Randomised controlled trial testing the effect of cotrimoxazole prophylaxis on morbidity and mortality outcomes in breastfed HIV-exposed uninfected infants: study protocol
Identifieur interne : 003889 ( Ncbi/Curation ); précédent : 003888; suivant : 003890Randomised controlled trial testing the effect of cotrimoxazole prophylaxis on morbidity and mortality outcomes in breastfed HIV-exposed uninfected infants: study protocol
Auteurs : Anna Coutsoudis [Afrique du Sud] ; Brodie Daniels [Afrique du Sud] ; Eshia Moodley-Govender [Afrique du Sud] ; Noluthando Ngomane [Afrique du Sud] ; Linda Zako [Afrique du Sud] ; Elizabeth Spooner [Afrique du Sud] ; Photini Kiepiela [Afrique du Sud] ; Shabashini Reddy [Afrique du Sud] ; Louise Kuhn [États-Unis] ; Gita Ramjee [Afrique du Sud]Source :
- BMJ Open [ 2044-6055 ] ; 2016.
Abstract
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.
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.
The study has ethical approval from the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC212/13).
PACTR201311000621110 and DOH-27-0614-4728; Pre-results.
Url:
DOI: 10.1136/bmjopen-2015-010656
PubMed: 27406638
PubMed Central: 4947798
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<front><div type="abstract" xml:lang="en"><sec><title>Introduction</title>
<p>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.</p>
</sec>
<sec><title>Methods</title>
<p>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.</p>
</sec>
<sec><title>Ethics and dissemination</title>
<p>The study has ethical approval from the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC212/13).</p>
</sec>
<sec><title>Trial registration numbers</title>
<p>PACTR201311000621110 and DOH-27-0614-4728; Pre-results.</p>
</sec>
</div>
</front>
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