Cotrimoxazole versus sulfadoxine–pyrimethamine for intermittent preventive treatment of malaria in HIV‐infected pregnant women in Bangui, Central African Republic: A pragmatic randomised controlled trial

• Published in: Tropical medicine & international health 2021-10, Vol.26 (10), p.1314-1323
• Main Authors: Manirakiza, Alexandre, Tondeur, Laura, Ketta, Marie Yvette Batoumbou, Sepou, Abdoulaye, Serdouma, Eugène, Gondje, Samuel, Bata, Ghislain Géraud Banthas, Boulay, Aude, Moyen, Jean Methode, Sakanga, Olga, Le‐Fouler, Lenaig, Kazanji, Mirdad, Briand, Valerie, Lombart, Jean Pierre, Vray, Muriel
• Format: Article
• Language: English
• Subjects: Adult; Adverse events; Antimalarials - administration & dosage; Antimalarials - therapeutic use; Birth weight; CD4 antigen; Central African Republic - epidemiology; Cotrimoxazole; Drug Combinations; Female; HIV; HIV Infections - complications; HIV Infections - epidemiology; Human health and pathology; Human immunodeficiency virus; Humans; Infections; Infectious diseases; Life Sciences; Malaria; Malaria - epidemiology; Malaria - prevention & control; Neonates; Pharmaceutical sciences; Pharmacology; Pharmacovigilance; Placenta; Pregnancy; Pregnancy Complications, Parasitic - drug therapy; pregnant women; Prophylaxis; prophylaxis HIV; Public health; Pyrimethamine; Pyrimethamine - pharmacology; Santé publique et épidémiologie; Sulfadoxine; Sulfadoxine - pharmacology; Trimethoprim, Sulfamethoxazole Drug Combination - pharmacology; Vector-borne diseases; Young Adult
• ISSN: 1360-2276; 1365-3156
• DOI: 10.1111/tmi.13668

Objective The main objective of the MACOMBA (Maternity and Control of Malaria‐HIV co‐infection in Bangui) trial was to show that cotrimoxazole (CTX) is more effective than sulphadoxine–pyremethamine–IPTp (IPTp‐SP) to prevent placental malaria infection (primary end point) among HIV‐positive pregnant women with a CD4+ count ≥350 cells/mm3 in Bangui, CAR. Methods MACOMBA is a multicentre, open‐label randomised trial conducted in four maternity hospitals in Bangui. Between 2013 and 2017, 193 women were randomised and 112 (59 and 53 in CTX and IPTp‐SP arms, respectively) were assessed for placental infection defined by microscopic parasitaemia or PCR. Results Thirteen women had a placental infection: five in the CTX arm (one by microscopic placental parasitaemia and four by PCR) and eight by PCR in the SP‐IPTp (8.5% vs. 15.1%, p = 0.28). The percentage of newborns with low birthweight (