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Despite declining risk of vertical  HIV  transmission, prophylactic cotrimoxazole ( CTX ) remains widely used to reduce morbidity and mortality in the event of  HIV  infection among exposed infants, with an inherent risk of conferring commensal antimicrobial resistance. Using data from a randomized, placebo‐controlled trial of infant  CTX  prophylaxis, we sought to quantify emergence of antibiotic resistance.    Methods   HIV ‐exposed uninfected infants enrolled in the Botswana Mpepu study were randomized to prophylactic  CTX  or placebo between 14 and 34 days of life and continued through 15 months. Stool samples were collected from a subset of participating infants at randomization, three, and six months, and stored at −70°C prior to culture. Specimens that grew  Escherichia coli (E. coli)  or  Klebsiella  species ( Klebsiella  spp.) underwent antibiotic susceptibility testing by Kirby Bauer method using  CTX  ( CTX  1.25/23.75 μg) and Amoxicillin (10 μg) in Mueller Hinton agar. Fisher's exact testing was used to compare prevalence of resistance by randomization arm ( CTX /placebo).    Results and Discussion  A total of 381 stool samples from 220 infants were cultured: 118 at randomization, 151 at three months, and 112 at six‐months.  E. coli  was isolated from 206 specimens and  Klebsiella  spp. from 138 specimens. Resistance to  CTX  was common in both  E. coli  and  Klebsiella  spp. at the randomization visit (52.2% and 37.7% respectively) and did not differ by study arm.  E. Coli  isolates from  CTX  recipients at three and six months had 94.9% and 84.2%  CTX  resistance, as compared with 51.4% and 57.5%  CTX  resistance in isolates from placebo recipients ( p =0.01).  Klebsiella  spp. isolates from  CTX  recipients had 79.0% and 68.8%  CTX  resistance at three and six months, as compared with 19.1% and 14.3% in isolates from placebo recipients ( p <0.01).    Conclusions   HIV ‐exposed infants randomized to  CTX  prophylaxis had increased  CTX ‐resistant commensal gastrointestinal bacteria compared with placebo recipients. Additional research is needed to determine the longer‐term clinical, microbiologic, and public health consequences of antimicrobial resistance selected by infant  CTX  prophylaxis.

journal of the international aids society

Cotrimoxazole prophylaxis was associated with enteric commensal bacterial resistance among HIV‐exposed infants in a randomized controlled trial, Botswana