PMID- 36633492 OWN - NLM STAT- MEDLINE DCOM- 20230116 LR - 20230118 IS - 1465-3664 (Electronic) IS - 0142-6338 (Linking) VI - 69 IP - 1 DP - 2022 Dec 5 TI - Cluster-randomized controlled trial of intermittent preventive treatment in infancy using sulfadoxine-pyrimethamine (SP-IPTi): a pilot study in Nigeria. LID - fmad001 [pii] LID - 10.1093/tropej/fmad001 [doi] AB - BACKGROUND: Malaria kills a child in sub-Saharan Africa every 2 min despite widely available interventions including intermittent preventive treatment in infants (IPTi). Since 2010, when World Health Organization (WHO) recommended IPTi, no country has implemented it. To our knowledge, no IPTi study has been conducted in Nigeria. Considering severity of malaria in infancy and urgency to improve malaria prevention, we proposed a study to investigate the efficacy of this intervention in reducing malarial morbidity and mortality. OBJECTIVE(S): The aim of this was to determine the safety and efficacy of SP-IPTi in reducing the prevalence of asymptomatic malaria parasitemia and malarial-associated hospital admissions. METHODS: We performed a cluster-randomized controlled trial in 1379 infants. SP was administered alongside routine vaccinations in immunization centers randomized to intervention groups. Infants in control groups received only routine vaccines. Malarial 'morbidity and adverse events were monitored through passive case-detection and cross-sectional surveys'. RESULTS: SP-IPTi was safe. There was no statistically significant difference in terms of risks of asymptomatic parasitemia at 9 months, fever or hospitalization between our control and intervention groups. CONCLUSIONS: Our study demonstrated that SP-IPTi had no benefit but was well tolerated. WHO and some researchers have also reported declining efficacy of SP, due to increasing drug resistance. CI - (c) The Author(s) [2023]. Published by Oxford University Press. FAU - Adeleke, Olumide Thomas AU - Adeleke OT AUID- ORCID: 0000-0001-6503-6416 AD - Department of Pediatrics, Bowen University Teaching Hospital, Ogbomoso 232101, Nigeria. FAU - Oyenuga, Abayomi AU - Oyenuga A AD - Department of Pediatrics, University of Minnesota, Minneapolis, MN 55414, USA. FAU - Slusher, Tina M AU - Slusher TM AUID- ORCID: 0000-0002-5798-5774 AD - Department of Pediatrics, Bowen University Teaching Hospital, Ogbomoso 232101, Nigeria. AD - Department of Pediatrics, University of Minnesota, Minneapolis, MN 55414, USA. AD - Department of Pediatrics, Hennepin Healthcare, Minneapolis, MN 55404, USA. FAU - Gbadero, Daniel A AU - Gbadero DA AD - Department of Pediatrics, Bowen University Teaching Hospital, Ogbomoso 232101, Nigeria. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - J Trop Pediatr JT - Journal of tropical pediatrics JID - 8010948 RN - 37338-39-9 (fanasil, pyrimethamine drug combination) RN - 0 (Antimalarials) RN - 0 (Drug Combinations) SB - IM MH - Child MH - Infant MH - Humans MH - *Antimalarials/therapeutic use MH - Pilot Projects MH - Nigeria/epidemiology MH - Cross-Sectional Studies MH - Parasitemia/diagnosis/drug therapy/epidemiology MH - *Malaria/epidemiology/prevention & control/drug therapy MH - Drug Combinations OTO - NOTNLM OT - Infant malaria OT - Intermittent preventive treatment OT - Malaria OT - Malaria prevention OT - Perennial malaria chemoprevention OT - SP-IP Ti EDAT- 2023/01/13 06:00 MHDA- 2023/01/17 06:00 CRDT- 2023/01/12 09:44 PHST- 2023/01/12 09:44 [entrez] PHST- 2023/01/13 06:00 [pubmed] PHST- 2023/01/17 06:00 [medline] AID - 6986163 [pii] AID - 10.1093/tropej/fmad001 [doi] PST - ppublish SO - J Trop Pediatr. 2022 Dec 5;69(1):fmad001. doi: 10.1093/tropej/fmad001.