南非健康婴儿的中性粒细胞计数:在非洲环境下临床试验的入组和不良事件分级的含义

Journal of Pediatrics: X Pub Date : 2019-03-01 DOI:10.1016/j.ympdx.2019.100005

Anthonet Koen MBBCh , Lisa Jose MBBCh , Shabir A. Madhi PhD , Alan Fix MD , Stanley Cryz PhD , Michelle J. Groome PhD

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引用次数: 2

摘要

在临床试验中，绝对中性粒细胞计数用于评估合格性和安全性，但使用的毒性分级量表可能会影响不良事件的登记和报告。在南非一项调查肠外轮状病毒疫苗的试验中，由于中性粒细胞减少症，我们将未感染艾滋病毒的健康婴儿排除在外。临床试验注册:NCT02109484。

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Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting

Absolute neutrophil counts are used to assess eligibility and safety during clinical trials but the toxicity grading scale used can affect enrollment and reporting of adverse events. During a trial investigating a parenteral rotavirus vaccine in South Africa, we excluded otherwise healthy infants without HIV infection from participation owing to neutropenia.