Randomised controlled trial testing the effect of cotrimoxazole prophylaxis on morbidity and mortality outcomes in breastfed HIV-exposed uninfected infants: study protocol
Randomised controlled trial testing the effect of cotrimoxazole prophylaxis on morbidity and mortality outcomes in breastfed HIV-exposed uninfected infants: study protocol
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DOI：
10.1136/bmjopen-2015-010656
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发表时间：
2016-01-01
期刊：
影响因子：
2.9
通讯作者：
Ramjee, Gita
中科院分区：
文献类型：
--
作者：
Coutsoudis, Anna;Daniels, Brodie;Ramjee, Gita
简介：在这个有效预防母婴传播（PMTCT）的新时代，没有随机对照试验（RCT）检查了复方新诺明（CTX）预防在母乳喂养期间暴露于HIV的未感染（HEU）婴儿中的疗效。CTX预防的有效性目前仅在HIV感染的儿童中得到证实。在与感染性疾病相关的高浓缩铀母乳喂养的婴儿中缺乏经证实的益处，因此有理由进行拟议的随机对照试验。Herewith在于进行拟议study.Methods的理由：部分盲随机对照试验，建议从6周龄的HEU婴儿接受PMTCT方案的CTX预防管理的疗效进行评估。将采用非劣效性设计，将1298名婴儿随机分为接受CTX或不接受CTX。将在以下时间点对受试者进行审查：6周（入组和随机化）、10周、14周、4个月和此后每月一次，直至12月龄。将对受试者的人体测量生长、间歇性疾病、CTX依从性、研究药物毒性的体征和症状、合并用药、母乳喂养状态和HIV感染状态进行评价。该研究将比较3级和4级常见儿童疾病（重点是肺炎和腹泻）的发病率和12个月之前的全因死亡率。在一个子集的参与者，我们将比较3级和4级血红蛋白和丙氨酸氨基转移酶的结果，以及调查肠道integrity.Ethics和传播：这项研究已从夸祖鲁-纳塔尔大学生物医学研究伦理委员会（BFC 212/13）的伦理批准。
Introduction: No randomised controlled trial (RCT) has examined the efficacy of cotrimoxazole (CTX) prophylaxis in HIV-exposed uninfected (HEU) infants during the breastfeeding period, in this new era of effective prevention of mother-to-child transmission (PMTCT) prophylaxis. The efficacy of CTX prophylaxis has presently been demonstrated only in HIV-infected children. The absence of proven benefits in HEU breastfed infants associated with infectious diseases justifies an RCT as proposed. Herewith lies the rationale for conducting the proposed study.Methods: A partially blinded RCT is proposed to evaluate the efficacy of CTX prophylaxis administered from 6 weeks of age to HEU infants receiving a PMTCT regimen. A non-inferiority design will be used, randomising 1298 infants to receive CTX or not to receive CTX. Participants will be reviewed at the following time points: 6 weeks (enrolment and randomisation), 10 weeks, 14 weeks, 4 months and monthly thereafter until 12 months of age. They will be evaluated for anthropometric growth, interval illness, CTX adherence, signs and symptoms of study drug toxicity, concomitant medication use, breastfeeding status and HIV infection status. The study will compare the incidence of grade 3 and grade 4 common childhood illnesses (focusing on pneumonia and diarrhoea) and all-cause mortality until 12 months of age. In a subset of participants, we will compare grade 3 and grade 4 haemoglobin and alanine aminotransferase results as well as investigate gut integrity.Ethics and dissemination: The study has ethical approval from the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC212/13).