PMID- 16195288 OWN - NLM STAT- MEDLINE DCOM- 20051011 LR - 20240314 IS - 1756-1833 (Electronic) IS - 0959-8138 (Print) IS - 0959-8138 (Linking) VI - 331 IP - 7519 DP - 2005 Oct 1 TI - Cluster randomised trial of intermittent preventive treatment for malaria in infants in area of high, seasonal transmission in Ghana. PG - 727-33 AB - OBJECTIVE: To evaluate the effects of intermittent preventive treatment for malaria in infants (IPTi) with sulfadoxine-pyrimethamine in an area of intense, seasonal transmission. DESIGN: Cluster randomised placebo controlled trial, with 96 clusters allocated randomly to sulfadoxine-pyrimethamine or placebo in blocks of eight. INTERVENTIONS: Children received sulfadoxine-pyrimethamine or placebo and one month of iron supplementation when they received DPT-2, DPT-3, or measles vaccinations and at 12 months of age. MAIN OUTCOME MEASURES: Incidence of malaria and of anaemia determined through passive case detection. RESULTS: 89% (1103/1242) of children in the placebo group and 88% (1088/1243) in the IPTi group completed follow-up to 24 months of age. The protective efficacy of IPTi against all episodes of malaria was 24.8% (95% confidence interval 14.3% to 34.0%) up to 15 months of age. IPTi had no protective effect against malaria between 16 and 24 months of age (protective efficacy -4.9%, -21.3% to 9.3%). The incidence of high parasite density malaria (> or = 5000 parasites/mul) was higher in the IPTi group than in the placebo group between 16 and 24 months of age (protective efficacy -19.5%, -39.8% to -2.2%). IPTi reduced hospital admissions with anaemia by 35.1% (10.5% to 52.9%) up to 15 months of age. IPTi had no significant effect on anaemia between 16 and 24 months of age (protective efficacy -6.4%, -76.8% to 35.9%). The relative risk of death up to 15 months of age in the IPTi group was 1.26 (95% confidence interval 0.81 to 1.96; P = 0.31), and from 16 to 24 months it was 1.28 (0.77 to 2.14; P = 0.35). CONCLUSIONS: Intermittent preventive treatment for malaria with sulfadoxine-pyrimethamine can reduce malaria and anaemia in infants even in seasonal, high transmission areas, but concern exists about possible rebound in the incidence of malaria in the second year of life. FAU - Chandramohan, Daniel AU - Chandramohan D AD - London School of Hygiene and Tropical Medicine, London WC1E 7HT. daniel.chandramohan@lshtm.ac.uk FAU - Owusu-Agyei, Seth AU - Owusu-Agyei S FAU - Carneiro, Ilona AU - Carneiro I FAU - Awine, Timothy AU - Awine T FAU - Amponsa-Achiano, Kwame AU - Amponsa-Achiano K FAU - Mensah, Nathan AU - Mensah N FAU - Jaffar, Shabbar AU - Jaffar S FAU - Baiden, Rita AU - Baiden R FAU - Hodgson, Abraham AU - Hodgson A FAU - Binka, Fred AU - Binka F FAU - Greenwood, Brian AU - Greenwood B LA - eng PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - BMJ JT - BMJ (Clinical research ed.) JID - 8900488 RN - 0 (Antimalarials) RN - 0 (Drug Combinations) RN - 37338-39-9 (fanasil, pyrimethamine drug combination) RN - 88463U4SM5 (Sulfadoxine) RN - Z3614QOX8W (Pyrimethamine) SB - IM MH - Anemia/mortality/parasitology MH - Antimalarials/*therapeutic use MH - Cluster Analysis MH - Drug Combinations MH - Ghana/epidemiology MH - Hospitalization/statistics & numerical data MH - Humans MH - Incidence MH - Infant MH - Malaria/mortality/*prevention & control MH - Parasitemia/epidemiology MH - Prevalence MH - Pyrimethamine/*therapeutic use MH - Seasons MH - Sulfadoxine/*therapeutic use MH - Treatment Outcome PMC - PMC1239974 EDAT- 2005/10/01 09:00 MHDA- 2005/10/12 09:00 PMCR- 2005/10/01 CRDT- 2005/10/01 09:00 PHST- 2005/10/01 09:00 [pubmed] PHST- 2005/10/12 09:00 [medline] PHST- 2005/10/01 09:00 [entrez] PHST- 2005/10/01 00:00 [pmc-release] AID - 331/7519/727 [pii] AID - 03310727 [pii] AID - 10.1136/bmj.331.7519.727 [doi] PST - ppublish SO - BMJ. 2005 Oct 1;331(7519):727-33. doi: 10.1136/bmj.331.7519.727.