Masking of an intravenous preparation of ceftriaxone for use in clinical trials: A technical report

IF 1.4 4区医学 Q3 CRITICAL CARE MEDICINE Critical Care and Resuscitation Pub Date : 2023-12-01 DOI:10.1016/j.ccrj.2023.10.002

David M. Golding MBBCh, BSc, PGDip , Tak Wai Chan BMedSci, BMBS , Nikola G. Orozov MPharm, PGDipClinPharm , Paul J. Young MBChB, PhD

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Abstract

Background

Intravenous antibiotics are often evaluated in clinical trials in hospitalised patients but for blinded trials masking of antibiotics is required.

Objective

To evaluate the effectiveness of masking of ceftriaxone and amoxicillin / clavulanic acid for use in blinded clinical trials.

Design, setting, and participants

Amoxicillin / clavulanic acid (1.2g) and ceftriaxone (1g and 2g) were diluted in 100mL of sodium chloride. Clinicians from a single centre were asked to attempt to distinguish solutions containing antibiotics from solutions without added antibiotics at time points up to 12 hours following dilution.

Results

1g of ceftriaxone diluted in 100 mL of 0.9 sodium chloride stored in a light-protected bag and refrigerated at 3–4 °C for up to 10 h could not readily be distinguished from 100 mL of 0.9 % sodium chloride. However, solutions containing either amoxicillin / clavulanic acid (1.2g) or ceftriaxone (2g) were readily identifiable.

Conclusions

1 g of ceftriaxone can be effectively masked by dilution in 100mL of sodium chloride.

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掩蔽用于临床试验的头孢曲松静脉注射制剂：技术报告

背景在住院患者的临床试验中经常会对静脉注射抗生素进行评估，但在盲法试验中需要对抗生素进行掩蔽。目的评估头孢曲松和阿莫西林/克拉维酸在盲法临床试验中的掩蔽效果。结果1克头孢曲松稀释在100毫升0.9%氯化钠中，储存在一个避光袋中，并在3-4 °C下冷藏10小时，不能轻易与100毫升0.9%氯化钠区分开来。然而，含有阿莫西林/克拉维酸（1.2 克）或头孢曲松（2 克）的溶液则很容易辨别。

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来源期刊

Critical Care and Resuscitation CRITICAL CARE MEDICINE-

CiteScore

7.70

自引率

3.40%

发文量

审稿时长

>12 weeks

期刊介绍： ritical Care and Resuscitation (CC&R) is the official scientific journal of the College of Intensive Care Medicine (CICM). The Journal is a quarterly publication (ISSN 1441-2772) with original articles of scientific and clinical interest in the specialities of Critical Care, Intensive Care, Anaesthesia, Emergency Medicine and related disciplines. The Journal is received by all Fellows and trainees, along with an increasing number of subscribers from around the world. The CC&R Journal currently has an impact factor of 3.3, placing it in 8th position in world critical care journals and in first position in the world outside the USA and Europe.