Background: Vaccination is the primary method of preventing influenza infection and complications in young children. We evaluated the efficacy and safety of a single dose of MEDI3250 (intranasal, quadrivalent, live attenuated influenza vaccine) in healthy Japanese children during the 2016/17 influenza season.
Methods: In this multicenter, randomized, double-blind, phase 3 study (jRCT2080223345), participants aged 2-18 years received MEDI3250 or placebo (2:1), stratified by age (2-6 years, 7-18 years). The primary and secondary endpoints were the incidence of confirmed symptomatic onset of influenza caused by a circulating wild-type strain or by a vaccine-matched strain, respectively. Safety outcomes included the incidence of adverse events (AEs) and vaccine-related AEs.
Results: Overall, 910 participants received MEDI3250 (n = 608) or placebo (n = 302). For the primary endpoint (regardless of the influenza subtype), the incidence of influenza onset was 25.5 % (MEDI3250) and 35.9 % (placebo); relative risk reduction, 28.8 % (95 % confidence interval, 12.5 %-42.0 %). For the secondary endpoint (vaccine-matched strain), the incidence was 10.9 % (MEDI3250) and 17.2 % (placebo); relative risk reduction, 36.6 % (95 % confidence interval, 6.5 %-56.8 %). Solicited AEs occurred in 67.6 % (MEDI3250) and 63.6 % (placebo). Most events were mild; nasal discharge was most common (59.2 % [MEDI3250] and 52.6 % [placebo]). Unsolicited AEs occurred in 36.0 % (MEDI3250) and 33.1 % (placebo). The most common unsolicited vaccine-related AE was diarrhea (2.3 %, both groups).
Conclusions: MEDI3250 had a greater preventive effect against influenza onset in Japanese children than placebo; no new safety signals were observed relative to previous clinical and post-marketing studies of MEDI3250.
{"title":"The efficacy and safety of a quadrivalent live attenuated influenza nasal vaccine in Japanese children: A phase 3, randomized, placebo-controlled study.","authors":"Tetsuo Nakayama, Takuya Hayashi, Kentaro Makino, Keiji Oe","doi":"10.1016/j.jiac.2024.06.023","DOIUrl":"10.1016/j.jiac.2024.06.023","url":null,"abstract":"<p><strong>Background: </strong>Vaccination is the primary method of preventing influenza infection and complications in young children. We evaluated the efficacy and safety of a single dose of MEDI3250 (intranasal, quadrivalent, live attenuated influenza vaccine) in healthy Japanese children during the 2016/17 influenza season.</p><p><strong>Methods: </strong>In this multicenter, randomized, double-blind, phase 3 study (jRCT2080223345), participants aged 2-18 years received MEDI3250 or placebo (2:1), stratified by age (2-6 years, 7-18 years). The primary and secondary endpoints were the incidence of confirmed symptomatic onset of influenza caused by a circulating wild-type strain or by a vaccine-matched strain, respectively. Safety outcomes included the incidence of adverse events (AEs) and vaccine-related AEs.</p><p><strong>Results: </strong>Overall, 910 participants received MEDI3250 (n = 608) or placebo (n = 302). For the primary endpoint (regardless of the influenza subtype), the incidence of influenza onset was 25.5 % (MEDI3250) and 35.9 % (placebo); relative risk reduction, 28.8 % (95 % confidence interval, 12.5 %-42.0 %). For the secondary endpoint (vaccine-matched strain), the incidence was 10.9 % (MEDI3250) and 17.2 % (placebo); relative risk reduction, 36.6 % (95 % confidence interval, 6.5 %-56.8 %). Solicited AEs occurred in 67.6 % (MEDI3250) and 63.6 % (placebo). Most events were mild; nasal discharge was most common (59.2 % [MEDI3250] and 52.6 % [placebo]). Unsolicited AEs occurred in 36.0 % (MEDI3250) and 33.1 % (placebo). The most common unsolicited vaccine-related AE was diarrhea (2.3 %, both groups).</p><p><strong>Conclusions: </strong>MEDI3250 had a greater preventive effect against influenza onset in Japanese children than placebo; no new safety signals were observed relative to previous clinical and post-marketing studies of MEDI3250.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141498179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Human cytomegalovirus (HCMV) infection occurs in immunosuppressed individuals and is known to increase mortality. Patients with coronavirus disease 2019 (COVID-19) are often treated with steroids, require intensive care unit (ICU) treatment, and may therefore be at risk for HCMV infection. However, which factors predispose severely ill patients with COVID-19 to HCMV infection and the prognostic value of such infections remain largely unexplored. This study aimed to examine the incidence and potential risk factors of HCMV infection in patients with severe or critical COVID-19 and evaluate the relationship between HCMV infection and mortality.
Methods and findings: We used administrative claims data from advanced treatment hospitals in Japan to identify and analyze patients with severe or critical COVID-19. We explored potential risk factors for HCMV infection using multivariable regression models and its contribution to mortality in patients with COVID-19. Overall, 33,151 patients who progressed to severe or critical COVID-19 illness were identified. The incidence of HCMV infection was 0.3-1.7 % depending on the definition of HCMV infection. Steroids, immunosuppressants, ICU admission, and blood transfusion were strongly associated with HCMV infection. Furthermore, HCMV infection was associated with patient mortality independent of the observed risk factors for death.
Conclusions: HCMV infection is a notable complication in patients with severe or critical COVID-19 who are admitted to the ICU or receive steroids, immunosuppressants, and blood transfusion and can significantly increase mortality risk.
{"title":"Incidence and potential risk factors of human cytomegalovirus infection in patients with severe and critical coronavirus disease 2019.","authors":"Waki Imoto, Takumi Imai, Ryota Kawai, Yasutaka Ihara, Yuta Nonomiya, Hiroki Namikawa, Koichi Yamada, Hisako Yoshida, Yukihiro Kaneko, Ayumi Shintani, Hiroshi Kakeya","doi":"10.1016/j.jiac.2024.06.015","DOIUrl":"10.1016/j.jiac.2024.06.015","url":null,"abstract":"<p><strong>Background: </strong>Human cytomegalovirus (HCMV) infection occurs in immunosuppressed individuals and is known to increase mortality. Patients with coronavirus disease 2019 (COVID-19) are often treated with steroids, require intensive care unit (ICU) treatment, and may therefore be at risk for HCMV infection. However, which factors predispose severely ill patients with COVID-19 to HCMV infection and the prognostic value of such infections remain largely unexplored. This study aimed to examine the incidence and potential risk factors of HCMV infection in patients with severe or critical COVID-19 and evaluate the relationship between HCMV infection and mortality.</p><p><strong>Methods and findings: </strong>We used administrative claims data from advanced treatment hospitals in Japan to identify and analyze patients with severe or critical COVID-19. We explored potential risk factors for HCMV infection using multivariable regression models and its contribution to mortality in patients with COVID-19. Overall, 33,151 patients who progressed to severe or critical COVID-19 illness were identified. The incidence of HCMV infection was 0.3-1.7 % depending on the definition of HCMV infection. Steroids, immunosuppressants, ICU admission, and blood transfusion were strongly associated with HCMV infection. Furthermore, HCMV infection was associated with patient mortality independent of the observed risk factors for death.</p><p><strong>Conclusions: </strong>HCMV infection is a notable complication in patients with severe or critical COVID-19 who are admitted to the ICU or receive steroids, immunosuppressants, and blood transfusion and can significantly increase mortality risk.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141468557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-27DOI: 10.1016/j.jiac.2024.06.021
Some reports suggest that coronavirus disease 2019 (COVID-19) may affect male reproductive function. There is also concern in Japan that COVID-19 may contribute to the pre-existing decline in male fertility; however, no studies have investigated the effects of COVID-19 on male reproductive function. In this study, we aimed to analyze the semen quality of men who had recovered from COVID-19. Male patients who had recovered from COVID-19 between February 2020 and September 2021 were recruited for this study. Participants were sent a semen collection kit; they were asked to collect semen at home and deliver it to a laboratory at Osaka University. We used these samples to analyze sperm concentration, total sperm count, and semen volume. In total, 125 participants were included in this study. The median age of all patients was 46 years (interquartile range (IQR): 38–52 years). The severity of COVID-19 was mild in 80 patients; 19 were moderate I, 22 were moderate II, and four were severe. The median semen volume was 2.5 mL (IQR: 1.8–3.1), the median sperm concentration was 98.9 million/mL (IQR: 43.8–162.2), and the median total sperm count was 212.1 million (IQR: 89.7–368.2). In a previous study in Japan, the median sperm count in adult men was reported to be 201 million. Participants in our study did not have lower sperm counts than this, despite their older age. Our results suggest that the long-term effects of COVID-19 on spermatogenesis are minimal.
{"title":"Association between post-COVID-19 conditions and male semen quality in Japan: A descriptive investigation","authors":"","doi":"10.1016/j.jiac.2024.06.021","DOIUrl":"10.1016/j.jiac.2024.06.021","url":null,"abstract":"<div><p>Some reports suggest that coronavirus disease 2019 (COVID-19) may affect male reproductive function. There is also concern in Japan that COVID-19 may contribute to the pre-existing decline in male fertility; however, no studies have investigated the effects of COVID-19 on male reproductive function. In this study, we aimed to analyze the semen quality of men who had recovered from COVID-19. Male patients who had recovered from COVID-19 between February 2020 and September 2021 were recruited for this study. Participants were sent a semen collection kit; they were asked to collect semen at home and deliver it to a laboratory at Osaka University. We used these samples to analyze sperm concentration, total sperm count, and semen volume. In total, 125 participants were included in this study. The median age of all patients was 46 years (interquartile range (IQR): 38–52 years). The severity of COVID-19 was mild in 80 patients; 19 were moderate I, 22 were moderate II, and four were severe. The median semen volume was 2.5 mL (IQR: 1.8–3.1), the median sperm concentration was 98.9 million/mL (IQR: 43.8–162.2), and the median total sperm count was 212.1 million (IQR: 89.7–368.2). In a previous study in Japan, the median sperm count in adult men was reported to be 201 million. Participants in our study did not have lower sperm counts than this, despite their older age. Our results suggest that the long-term effects of COVID-19 on spermatogenesis are minimal.</p></div>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1341321X24001764/pdfft?md5=a2f6ebf03c4a8eae77867d731f97ce6a&pid=1-s2.0-S1341321X24001764-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141468543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: We investigated whether the initial voriconazole (VRCZ) dosing design, as determined using simulation software with a population pharmacokinetic model of Japanese patients, impacts the effectiveness and safety when compared with VRCZ initiation according to the package insert.
Methods: In this single-center retrospective observational study, we employed records from Tosei General Hospital (a 633-bed hospital), dated April 2017 to September 2023. Eligible patients were divided into the software-based simulation group, comprising patients administered initial VRCZ dosage adjustment by pharmacists using software-based simulation, and the standard therapy group, whose dosage was administered by a physician following the package insert recommendations without simulation. The primary objective of this study was to determine the efficacy of VRCZ first-dose design in reducing the incidence of hepatotoxicity and visual symptoms.
Results: The median ages of enrolled participants (n = 93) were 75 (68-79) and 72 (65-78) years in the software-based simulation and standard therapy groups, respectively. Regardless of formulation, initial trough concentrations were lower in the VRCZ software-based first dosage adjustment group and higher rate within the appropriate range (1-4 μg/mL). The incidence of all-grade hepatotoxicity or visual symptoms was significantly lower in the software-based simulation group. The log-rank test revealed a significant impact on the occurrence of ≥grade 2 hepatotoxicity in the software-based first dosage adjustment group compared to that in the standard therapy group.
Conclusions: The initial VRCZ dosing design using simulation software improved the achievement of appropriate initial trough concentrations and resulted in fewer occurrences of hepatotoxicity (≥grade 2) when compared with the standard therapy.
{"title":"Effectiveness and safety of the simulation-based first-dose design of voriconazole.","authors":"Takumi Umemura, Hiromi Kakizaki, Yoshikazu Mutoh, Takahito Mizuno, Yuki Ito, Tatsuya Hioki, Hideo Kato, Mao Hagihara, Tetsuya Yamada, Yoshiaki Ikeda, Hiroshige Mikamo, Toshihiko Ichihara, Yukihiro Hamada","doi":"10.1016/j.jiac.2024.06.016","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.06.016","url":null,"abstract":"<p><strong>Background: </strong>We investigated whether the initial voriconazole (VRCZ) dosing design, as determined using simulation software with a population pharmacokinetic model of Japanese patients, impacts the effectiveness and safety when compared with VRCZ initiation according to the package insert.</p><p><strong>Methods: </strong>In this single-center retrospective observational study, we employed records from Tosei General Hospital (a 633-bed hospital), dated April 2017 to September 2023. Eligible patients were divided into the software-based simulation group, comprising patients administered initial VRCZ dosage adjustment by pharmacists using software-based simulation, and the standard therapy group, whose dosage was administered by a physician following the package insert recommendations without simulation. The primary objective of this study was to determine the efficacy of VRCZ first-dose design in reducing the incidence of hepatotoxicity and visual symptoms.</p><p><strong>Results: </strong>The median ages of enrolled participants (n = 93) were 75 (68-79) and 72 (65-78) years in the software-based simulation and standard therapy groups, respectively. Regardless of formulation, initial trough concentrations were lower in the VRCZ software-based first dosage adjustment group and higher rate within the appropriate range (1-4 μg/mL). The incidence of all-grade hepatotoxicity or visual symptoms was significantly lower in the software-based simulation group. The log-rank test revealed a significant impact on the occurrence of ≥grade 2 hepatotoxicity in the software-based first dosage adjustment group compared to that in the standard therapy group.</p><p><strong>Conclusions: </strong>The initial VRCZ dosing design using simulation software improved the achievement of appropriate initial trough concentrations and resulted in fewer occurrences of hepatotoxicity (≥grade 2) when compared with the standard therapy.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141468546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-26DOI: 10.1016/j.jiac.2024.06.013
Background
Drug resistance is an important factor in the fight against influenza A virus (IAV). Natural products offer a rich source of lead compounds for the discovery of novel antiviral drugs. In a previous study, we isolated the sorbicillinoid polyketide HSL-2 from the mycelium of fungus Trichoderma sp. T-4-1. Here, we show that this compound exerts strong antiviral activity against a panel of IAVs.
Methods
The immunofluorescence and qRT-PCR assays were used to detect the inhibitory effect of HSL-2 toward the replication of influenza virus and IAV-induced expression of the pro-inflammatory cytokines such as TNF-α, IL-6, and IL-1β.
Results
The results indicated that HSL-2 inhibited influenza virus replication, and it significantly inhibited IAV-induced overexpression of the pro-inflammatory cytokines TNF-α, IL-6, and IL-1β through modulating the PPAR-γ/NF-κB pathway. Notably, this effect was decreased when cells were transfected with PPAR-γ siRNA or treated with the PPAR-γ inhibitor T0070907. In addition, HSL-2 was able to attenuate lung inflammatory responses and to improve lung lesions in a mouse model of IAV infection.
Conclusions
In this paper, we identified a microbial secondary metabolite, HSL-2, with anti-influenza virus activity. This report is the first to describe the antiviral activity and mechanism of action of HSL-2, and it provides a new strategy for the development of novel anti-influenza virus drugs from natural sources.
{"title":"Sorbicillinoid HSL-2 inhibits the infection of influenza A virus via interaction with the PPAR-γ/NF-κB pathway","authors":"","doi":"10.1016/j.jiac.2024.06.013","DOIUrl":"10.1016/j.jiac.2024.06.013","url":null,"abstract":"<div><h3>Background</h3><div><span><span>Drug resistance is an important factor in the fight against influenza A virus<span> (IAV). Natural products offer a rich source </span></span>of lead compounds<span> for the discovery of novel antiviral drugs. In a previous study, we isolated the sorbicillinoid polyketide </span></span><strong>HSL-2</strong><span> from the mycelium of fungus </span><span><span>Trichoderma</span></span><span> sp. T-4-1. Here, we show that this compound exerts strong antiviral activity against a panel of IAVs.</span></div></div><div><h3>Methods</h3><div>The immunofluorescence and qRT-PCR assays were used to detect the inhibitory effect of <strong>HSL-2</strong> toward the replication of influenza virus and IAV-induced expression of the pro-inflammatory cytokines such as TNF-α, IL-6, and IL-1β.</div></div><div><h3>Results</h3><div>The results indicated that <strong>HSL-2</strong><span><span> inhibited influenza virus replication, and it significantly inhibited IAV-induced overexpression of the pro-inflammatory cytokines TNF-α, IL-6, and IL-1β through modulating the PPAR-γ/NF-κB pathway. Notably, this effect was decreased when cells were transfected with PPAR-γ siRNA or treated with the PPAR-γ inhibitor </span>T0070907. In addition, </span><strong>HSL-2</strong><span> was able to attenuate lung inflammatory responses<span><span> and to improve lung lesions in a mouse model of </span>IAV infection.</span></span></div></div><div><h3>Conclusions</h3><div><span>In this paper, we identified a microbial secondary metabolite, </span><strong>HSL-2</strong><span>, with anti-influenza virus activity. This report is the first to describe the antiviral activity and mechanism of action of </span><strong>HSL-2</strong>, and it provides a new strategy for the development of novel anti-influenza virus drugs from natural sources.</div></div>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141468559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-26DOI: 10.1016/j.jiac.2024.06.019
Enterococci are Gram-positive coccus bacteria that are normally present in the gastrointestinal tract and ordinarily function commensally with humans. Very few studies have investigated the characteristics of enterococcal infections. We aimed to characterize patients with urinary tract infections (UTIs) due to Enterococci and their outcomes. This was a retrospective cohort study between June 2012–November 2022. Patients who had clinically and microbiologically confirmed Enterococcal UTI based on a urine culture positive for E. faecalis or E. faecium with a count of ≥105 CFU/mL and having urinary tract symptoms were included. A total of 396 patients were eligible and included. The patients had a median age of 61 years and were mostly females (56.8 %). The most common characteristics were hospitalization in a non-ICU ward, having a urinary catheter, and recent use of antibiotics within the last 3 months (66.4 %, 59.3 %, and 51.8 %, respectively). Infection with E. faecalis was more common than E. faecium (77.3 % vs. 22.7 %). However, the latter exhibited higher rates of antibiotic resistance (P < 0.001 to several antibiotics) and was associated with significantly higher median C-reactive protein level (26.7 vs. 13 mg/dL; P = 0.025), mortality (23 % vs. 10.1 %; P = 0.002), and median length of stay (25 vs. 11.5 days; P < 0.001). We found that most patients with enterococcal UTIs had a history of having a urinary catheter and recent antibiotic use and were mostly females and hospitalized in non-ICU wards. E. faecium-infected patients experienced more severe episodes and poorer outcomes compared to patients infected with E. faecalis; thus, would need more aggressive therapy.
{"title":"Characteristics and outcomes of urinary tract infections caused by Enterococci: A multicenter retrospective study from two tertiary hospitals in Saudi Arabia","authors":"","doi":"10.1016/j.jiac.2024.06.019","DOIUrl":"10.1016/j.jiac.2024.06.019","url":null,"abstract":"<div><p><em>Enterococci</em> are Gram-positive coccus bacteria that are normally present in the gastrointestinal tract and ordinarily function commensally with humans. Very few studies have investigated the characteristics of enterococcal infections. We aimed to characterize patients with urinary tract infections (UTIs) due to <em>Enterococci</em> and their outcomes. This was a retrospective cohort study between June 2012–November 2022. Patients who had clinically and microbiologically confirmed Enterococcal UTI based on a urine culture positive for <em>E. faecalis</em> or <em>E. faecium</em> with a count of ≥10<sup>5</sup> CFU/mL and having urinary tract symptoms were included. A total of 396 patients were eligible and included. The patients had a median age of 61 years and were mostly females (56.8 %). The most common characteristics were hospitalization in a non-ICU ward, having a urinary catheter, and recent use of antibiotics within the last 3 months (66.4 %, 59.3 %, and 51.8 %, respectively). Infection with <em>E. faecalis</em> was more common than <em>E. faecium</em> (77.3 % vs. 22.7 %). However, the latter exhibited higher rates of antibiotic resistance (<em>P</em> < 0.001 to several antibiotics) and was associated with significantly higher median C-reactive protein level (26.7 vs. 13 mg/dL; <em>P</em> = 0.025), mortality (23 % vs. 10.1 %; <em>P</em> = 0.002), and median length of stay (25 vs. 11.5 days; <em>P</em> < 0.001). We found that most patients with enterococcal UTIs had a history of having a urinary catheter and recent antibiotic use and were mostly females and hospitalized in non-ICU wards. <em>E. faecium</em>-infected patients experienced more severe episodes and poorer outcomes compared to patients infected with <em>E. faecalis</em>; thus, would need more aggressive therapy.</p></div>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1341321X24001740/pdfft?md5=eb96cea5053e17eeb571ab6408904e59&pid=1-s2.0-S1341321X24001740-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141468545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Severe fever with thrombocytopenia syndrome (SFTS) is an infectious disease that presents a formidable challenge due to the absence of established therapeutic strategies that are explicitly tailored to its management. This study aimed to assess the impact of routine antimicrobial therapy on patients diagnosed with SFTS in Japan. We conducted a comprehensive retrospective cohort analysis using extensive data from a national inpatient database.
Methods: This study scrutinized data from adult patients with SFTS and categorized them based on whether they received antimicrobial treatment within the initial 2 days of hospital admission. A meticulous evaluation was carried out on a range of outcomes, such as in-hospital mortality rates, overall costs associated with hospitalization, and length of hospital stay. Overlap weighting was applied along with multivariate regression models to enhance the reliability of the findings through confounder adjustment. The outcomes showed no significant improvement in the prognosis of patients with SFTS who received routine antimicrobial therapy. The use of antimicrobials did not yield statistically significant improvements in in-hospital mortality rates or other secondary outcomes, suggesting that such therapeutic interventions may not be necessary during the early stages of hospital admission.
Conclusion: In our study, administration of antimicrobials within 2 days of admission for SFTS did not affect prognosis. The standard use of antimicrobial treatments may be an issue that should be reconsidered.
{"title":"Exploring the efficacy of routine antimicrobial therapy in severe fever with thrombocytopenia syndrome: Overlap weighting analysis using a nationwide inpatient database.","authors":"Satoshi Kutsuna, Hiroyuki Ohbe, Hiroki Matsui, Hideo Yasunaga","doi":"10.1016/j.jiac.2024.06.020","DOIUrl":"https://doi.org/10.1016/j.jiac.2024.06.020","url":null,"abstract":"<p><strong>Background: </strong>Severe fever with thrombocytopenia syndrome (SFTS) is an infectious disease that presents a formidable challenge due to the absence of established therapeutic strategies that are explicitly tailored to its management. This study aimed to assess the impact of routine antimicrobial therapy on patients diagnosed with SFTS in Japan. We conducted a comprehensive retrospective cohort analysis using extensive data from a national inpatient database.</p><p><strong>Methods: </strong>This study scrutinized data from adult patients with SFTS and categorized them based on whether they received antimicrobial treatment within the initial 2 days of hospital admission. A meticulous evaluation was carried out on a range of outcomes, such as in-hospital mortality rates, overall costs associated with hospitalization, and length of hospital stay. Overlap weighting was applied along with multivariate regression models to enhance the reliability of the findings through confounder adjustment. The outcomes showed no significant improvement in the prognosis of patients with SFTS who received routine antimicrobial therapy. The use of antimicrobials did not yield statistically significant improvements in in-hospital mortality rates or other secondary outcomes, suggesting that such therapeutic interventions may not be necessary during the early stages of hospital admission.</p><p><strong>Conclusion: </strong>In our study, administration of antimicrobials within 2 days of admission for SFTS did not affect prognosis. The standard use of antimicrobial treatments may be an issue that should be reconsidered.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141468547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-26DOI: 10.1016/j.jiac.2024.06.014
Sinan Çetin, Ahmet Melih Şahin
Background: In Crimean-Congo hemorrhagic fever, bleeding has a significant impact on the prognosis of the disease. In our study, we aimed to identify independent risk factors for the development of bleeding in Crimean-Congo hemorrhagic fever and to contribute to the management of the disease.
Methods: Cases with a definitive diagnosis of Crimean-Congo hemorrhagic fever were divided into two groups: those who developed bleeding and those who did not. Demographic, clinical and laboratory parameters were subjected to logistic regression analysis in terms of risk factors for bleeding development. Cut-off values for numerical variables were determined by receiver operating characteristics.
Results: A total of 74 patients diagnosed with CCHF were included in the study. Bleeding occurred in at least one defined focus in 21 patients. In the multivariate logistic regression model, procalcitonin, days from symptom onset to admission, platelet count, and d-dimer were identified as independent risk factors for bleeding development. Procalcitonin had the most significant effect, with an approximately 5.3-fold increase in bleeding risk for each unit increase in its level. For discriminate bleeding, LDH and ferritin exhibited the highest sensitivity, while procalcitonin showed the highest specificity.
Conclusion: This study demonstrates the potential use of specific clinical and laboratory variables to predict bleeding development in CCHF patients. Procalcitonin elevation and the time from symptom onset to hospital admission have a significant effect in predicting bleeding.
{"title":"Can we predict bleeding at admission in Crimean-Congo hemorrhagic fever?","authors":"Sinan Çetin, Ahmet Melih Şahin","doi":"10.1016/j.jiac.2024.06.014","DOIUrl":"10.1016/j.jiac.2024.06.014","url":null,"abstract":"<p><strong>Background: </strong>In Crimean-Congo hemorrhagic fever, bleeding has a significant impact on the prognosis of the disease. In our study, we aimed to identify independent risk factors for the development of bleeding in Crimean-Congo hemorrhagic fever and to contribute to the management of the disease.</p><p><strong>Methods: </strong>Cases with a definitive diagnosis of Crimean-Congo hemorrhagic fever were divided into two groups: those who developed bleeding and those who did not. Demographic, clinical and laboratory parameters were subjected to logistic regression analysis in terms of risk factors for bleeding development. Cut-off values for numerical variables were determined by receiver operating characteristics.</p><p><strong>Results: </strong>A total of 74 patients diagnosed with CCHF were included in the study. Bleeding occurred in at least one defined focus in 21 patients. In the multivariate logistic regression model, procalcitonin, days from symptom onset to admission, platelet count, and d-dimer were identified as independent risk factors for bleeding development. Procalcitonin had the most significant effect, with an approximately 5.3-fold increase in bleeding risk for each unit increase in its level. For discriminate bleeding, LDH and ferritin exhibited the highest sensitivity, while procalcitonin showed the highest specificity.</p><p><strong>Conclusion: </strong>This study demonstrates the potential use of specific clinical and laboratory variables to predict bleeding development in CCHF patients. Procalcitonin elevation and the time from symptom onset to hospital admission have a significant effect in predicting bleeding.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141468544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-25DOI: 10.1016/j.jiac.2024.06.017
So Yun Lim, Hong Soon Yim, Eun Jung Ahn, Euijin Chang, Jonghee Yoon, Ja-Hee Suh, Jihye Um, Hyang Su Kim, Min-Kyung Kim, Yeonjae Kim, Gayeon Kim, Jaehyun Jeon, Jun-Sun Park, BumSik Chin
This severe monkeypox case described a 23-year-old male with advanced HIV-1 disease presenting perirectal abscess, extensive anal ulcerative lesions requiring colostomy, and tecovirimat resistance. Radiologically non-liquefied perirectal abscess presented diagnostic challenges highlighting the complexity of aggressive monkeypox manifestations in immunocompromised individuals.
{"title":"Severe mpox requiring colostomy in a patient with advanced HIV disease: A case report and literature review.","authors":"So Yun Lim, Hong Soon Yim, Eun Jung Ahn, Euijin Chang, Jonghee Yoon, Ja-Hee Suh, Jihye Um, Hyang Su Kim, Min-Kyung Kim, Yeonjae Kim, Gayeon Kim, Jaehyun Jeon, Jun-Sun Park, BumSik Chin","doi":"10.1016/j.jiac.2024.06.017","DOIUrl":"10.1016/j.jiac.2024.06.017","url":null,"abstract":"<p><p>This severe monkeypox case described a 23-year-old male with advanced HIV-1 disease presenting perirectal abscess, extensive anal ulcerative lesions requiring colostomy, and tecovirimat resistance. Radiologically non-liquefied perirectal abscess presented diagnostic challenges highlighting the complexity of aggressive monkeypox manifestations in immunocompromised individuals.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141468558","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: A change in empirical antibiotics or the addition of glycopeptide antibiotics is often applied in cases of persistent febrile neutropenia (FN) despite the administration of broad-spectrum antibiotics. However, the clinical benefit of these approaches remains unclear.
Methods: We conducted a retrospective study to evaluate the effectiveness of a change in antibiotics or the addition of glycopeptide antibiotics for persistent FN after autologous hematopoietic cell transplantation (auto-HCT). We retrospectively reviewed the records of 208 patients who received auto-HCT at our institution between 2007 and 2019. FN that lasted for 4 days or longer was defined as persistent FN. We compared the time to defervescence between patients whose initial antibiotics were changed and/or who additionally received glycopeptide antibiotics, and those without these antibiotic modifications.
Results: Among patients who fulfilled the criteria of persistent FN (n = 125), changes in antibiotics were not significantly associated with the time to defervescence in a multivariate analysis (hazard ratio [HR] 0.72, p = 0.27). On the other hand, the addition of glycopeptide antibiotics was paradoxically associated with a delay in defervescence (HR 0.56, p = 0.033).
Conclusions: Although there may be differences in patient backgrounds, no significant differences were observed in either a univariate or multivariate analysis. Since neither a change in antibiotics nor the addition of glycopeptide antibiotics was associated with earlier defervescence in persistent FN after auto-HCT, routine antibiotic modifications might not be necessary in this setting.
{"title":"Clinical impact of a change in antibiotics or the addition of glycopeptide antibiotics for persistent febrile neutropenia after autologous stem cell transplantation.","authors":"Nozomu Yoshino, Shun-Ichi Kimura, Koji Kawamura, Yuya Nakata, Akari Matsuoka, Takuto Ishikawa, Tomohiro Meno, Yuhei Nakamura, Masakatsu Kawamura, Shunto Kawamura, Junko Takeshita, Yukiko Misaki, Kazuki Yoshimura, Ayumi Gomyo, Yosuke Okada, Masaharu Tamaki, Machiko Kusuda, Kazuaki Kameda, Yu Akahoshi, Miki Sato, Aki Tanihara, Hideki Nakasone, Shinichi Kako, Yoshinobu Kanda","doi":"10.1016/j.jiac.2024.06.018","DOIUrl":"10.1016/j.jiac.2024.06.018","url":null,"abstract":"<p><strong>Background: </strong>A change in empirical antibiotics or the addition of glycopeptide antibiotics is often applied in cases of persistent febrile neutropenia (FN) despite the administration of broad-spectrum antibiotics. However, the clinical benefit of these approaches remains unclear.</p><p><strong>Methods: </strong>We conducted a retrospective study to evaluate the effectiveness of a change in antibiotics or the addition of glycopeptide antibiotics for persistent FN after autologous hematopoietic cell transplantation (auto-HCT). We retrospectively reviewed the records of 208 patients who received auto-HCT at our institution between 2007 and 2019. FN that lasted for 4 days or longer was defined as persistent FN. We compared the time to defervescence between patients whose initial antibiotics were changed and/or who additionally received glycopeptide antibiotics, and those without these antibiotic modifications.</p><p><strong>Results: </strong>Among patients who fulfilled the criteria of persistent FN (n = 125), changes in antibiotics were not significantly associated with the time to defervescence in a multivariate analysis (hazard ratio [HR] 0.72, p = 0.27). On the other hand, the addition of glycopeptide antibiotics was paradoxically associated with a delay in defervescence (HR 0.56, p = 0.033).</p><p><strong>Conclusions: </strong>Although there may be differences in patient backgrounds, no significant differences were observed in either a univariate or multivariate analysis. Since neither a change in antibiotics nor the addition of glycopeptide antibiotics was associated with earlier defervescence in persistent FN after auto-HCT, routine antibiotic modifications might not be necessary in this setting.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141457342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}