Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201311000621110 Date of Approval: 21/08/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title RCT of effect of cotrimoxazole on the health of HIV-exposed unifected infants
Official scientific title Randomized controlled trial testing the effect of cotrimoxazole prophylaxis on morbidity and mortality outcomes in breastfed HIV-exposed uninfected infants
Brief summary describing the background and objectives of the trial There is a call for reconsideration of the current WHO guidelines on the use of an antibiotic, cotrimoxazole (CTX), as prophylaxis for HIV-exposed uninfected breastfeeding infants (HEUs). This RCT is a non-inferiority study design comparing the morbidity and mortality in those infants receiving CTX vs those who are not. Infants might be unnecessarily exposed to antibiotics which disturb the bacterial flora and gut immunity, therefore gut integrity and microbiota will be examined in a sub-sample.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 16/09/2013
Actual trial start date 16/10/2013
Anticipated date of last follow up 31/07/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 1298
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
BFC212/13 Biomedical Research Ethics Committee (UKZN)
BFC212/13 Biomedical Research Ethics (UKZN)
BFC212/13 Biomedical Research Ethics (UKZN)
BFC212/13 Biomedical Research Ethics Committee (UKZN)
BFC212/13 Biomedical Research Ethics (UKZN)
BFC212/13 Biomedical Research Ethics Committee (UKZN)
BFC212/13 Biomedical Research Ethics Committee (UKZN)
BFC212/13 Biomedical Research Ethics Committee (UKZN)
BFC212/13 Biomedical Research Ethics Committee (UKZN)
BFC212/13 Biomedical Research Ethics (UKZN)
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Open-label(Masking Not Used)
Randomised Simple randomisation using procedures such as coin-tossing (self-selected card system) Sealed opaque envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using by using procedures such as coin-tossing (self-selected card system) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group CTX prophylaxis According to WHO guidelines for HEUs According to WHO guidelines CTX prophylaxis for HEUs as per WHO guidelines 649
Control Group No CTX prophylaxis No CTX provided and no placebo provided Duration of study No CTX prophylaxis 649
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Infant born to a woman with confirmed HIV infection; Written informed consent to enroll infant into study obtained from mother; Infant age 6 weeks (between day 35-49) at study entry; Infant should be breastfeeding at time of screening and should be planning to breastfeed for at least 6 months; HIV-negative from a screening test performed prior to study entry; Mother (or infant) should be receiving PMTCT regimen or mother should be receiving lifelong ART; Singleton birth; Birth weight >2000g; Infant has not had any illness and has not received prior antibiotics or traditional medications; Indeterminate HIV test result at screening; Receipt of antibiotics or traditional medications prior to study entry; A known requirement for CTX prophylaxis prior to study entry; A known contra-indication for CTX prophylaxis prior to study entry; Infants with any major serious illness (eg., heart, liver, kidney disease) or congenital malformation; 35 Day(s) 49 Day(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/07/2013 Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Research Office, Westville Campus, Govan Mbeki Building Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare incidence of grade 3 and 4 common childhood illnesses or all-cause mortality through 54 weeks of age in HEUs receiving CTX or no CTX. Week 10 Week 14 Week 18 Week 22 Week 30 Week 38 Week 46 Week 54
Secondary Outcome To compare incidence of grade 3 and 4 diarrheal events through 54 weeks of age in group receiving CTX vs no CTX Week 10 Week 14 Week 18 Week 22 Week 30 Week 38 Week 46 Week 54
Secondary Outcome To compare incidence of grade 3 and 4 pneumonia events through 54 weeks of age in group receiving CTX vs no CTX Week 10 Week 14 Week 18 Week 22 Week 30 Week 38 Week 46 Week 54
Secondary Outcome To compare the incidence of growth faltering events through 54 weeks of age in the group recieving CTX vs no CTX Week 10 Week 14 Week 18 Week 22 Week 30 Week 38 Week 46 Week 54
Secondary Outcome To compare concentrations of LPS and 16s ribosomal RNA in infant plasma in a subsample of infants receiving CTX vs no CTX week 2 week 6 week 18 week 22
Secondary Outcome To compare characteristics of gut microbiota in a subsample of infants receiving CTX vs no CTX week 2 week 6 week 18 week 22
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lancers Road 90 Lancers Road Durban 4001 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
HIV Prevention Research Unit, Medical Research Council of South Africa Village Market, 123 Jan Hofmeyer Road, Westville Durban 3630 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor eThekwini Municipality Health Unit 90 LANCERS ROAD WARWICK TRIANGLE CBD Durban 4000 South Africa Hospital
Primary Sponsor University of KwaZulu Natal Umbilo Road, Congella Durban 4013 South Africa University
COLLABORATORS
Name Street address City Postal code Country
eThekwini Municipality Health Unit 90 LANCERS ROAD WARWICK TRIANGLE CBD Durban 4000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Brodie Daniels Daniels@ukzn.ac.za 0312604489 Medical School, 719 Umbilo Rd, Congella
City Postal code Country Position/Affiliation
Durban 4000 South Africa Postdoctoral Fellow/PI
Role Name Email Phone Street address
Public Enquiries Eshia Moodley-Govender Moodleye@ukzn.ac.za 0312604489 Medical School, 719 Umbilo Rd, Congella
City Postal code Country Position/Affiliation
Durban 4000 South Africa Postdoctoral Fellow
Role Name Email Phone Street address
Scientific Enquiries Anna Coutsoudis COUTSOUD@ukzn.ac.za 0312604489 Medical School, 719 Umbilo Rd, Congella
City Postal code Country Position/Affiliation
Durban 4000 South Africa Professor
REPORTING
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Result URL Hyperlinks
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