Document Detail

Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials.
MedLine Citation:
PMID:  19765816     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Intermittent preventive treatment (IPT) is a promising strategy for malaria control in infants. We undertook a pooled analysis of the safety and efficacy of IPT in infants (IPTi) with sulfadoxine-pyrimethamine in Africa. METHODS: We pooled data from six double-blind, randomised, placebo-controlled trials (undertaken one each in Tanzania, Mozambique, and Gabon, and three in Ghana) that assessed the efficacy of IPTi with sulfadoxine-pyrimethamine. In all trials, IPTi or placebo was given to infants at the time of routine vaccinations delivered by WHO's Expanded Program on Immunization. Data from the trials for incidence of clinical malaria, risk of anaemia (packed-cell volume <25% or haemoglobin <80 g/L), and incidence of hospital admissions and adverse events in infants up to 12 months of age were reanalysed by use of standard outcome definitions and time periods. Analysis was by modified intention to treat, including all infants who received at least one dose of IPTi or placebo. FINDINGS: The six trials provided data for 7930 infants (IPTi, n=3958; placebo, n=3972). IPTi had a protective efficacy of 30.3% (95% CI 19.8-39.4, p<0.0001) against clinical malaria, 21.3% (8.2-32.5, p=0.002) against the risk of anaemia, 38.1% (12.5-56.2, p=0.007) against hospital admissions associated with malaria parasitaemia, and 22.9% (10.0-34.0, p=0.001) against all-cause hospital admissions. There were 56 deaths in the IPTi group compared with 53 in the placebo group (rate ratio 1.05, 95% CI 0.72-1.54, p=0.79). One death, judged as possibly related to IPTi because it occurred 19 days after a treatment dose, was subsequently attributed to probable sepsis. Four of 676 non-fatal hospital admissions in the IPTi group were deemed related to study treatment compared with five of 860 in the placebo group. None of three serious dermatological adverse events in the IPTi group were judged related to study treatment compared with one of 13 in the placebo group. INTERPRETATION: IPTi with sulfadoxine-pyrimethamine was safe and efficacious across a range of malaria transmission settings, suggesting that this intervention is a useful contribution to malaria control. FUNDING: Bill & Melinda Gates Foundation.
John J Aponte; David Schellenberg; Andrea Egan; Alasdair Breckenridge; Ilona Carneiro; Julia Critchley; Ina Danquah; Alexander Dodoo; Robin Kobbe; Bertrand Lell; Jürgen May; Zul Premji; Sergi Sanz; Esperanza Sevene; Rachida Soulaymani-Becheikh; Peter Winstanley; Samuel Adjei; Sylvester Anemana; Daniel Chandramohan; Saadou Issifou; Frank Mockenhaupt; Seth Owusu-Agyei; Brian Greenwood; Martin P Grobusch; Peter G Kremsner; Eusebio Macete; Hassan Mshinda; Robert D Newman; Laurence Slutsker; Marcel Tanner; Pedro Alonso; Clara Menendez
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Publication Detail:
Type:  Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't; Review     Date:  2009-09-16
Journal Detail:
Title:  Lancet     Volume:  374     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-11-02     Completed Date:  2009-11-12     Revised Date:  2010-02-01    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  1533-42     Citation Subset:  AIM; IM    
Barcelona Centre for International Health Research, Hospital Clinic, University of Barcelona, Barcelona, Spain.
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MeSH Terms
Africa / epidemiology
Anemia / epidemiology
Antimalarials / adverse effects,  therapeutic use*
Double-Blind Method
Drug Administration Schedule
Drug Combinations
Follow-Up Studies
Immunization Schedule
Infant Mortality
Malaria, Falciparum / epidemiology,  prevention & control*
Patient Admission / statistics & numerical data
Pyrimethamine / adverse effects,  therapeutic use*
Randomized Controlled Trials as Topic
Regression Analysis
Research Design
Risk Factors
Sulfadoxine / adverse effects,  therapeutic use*
Treatment Outcome
Reg. No./Substance:
0/Antimalarials; 0/Drug Combinations; 2447-57-6/Sulfadoxine; 37338-39-9/sulfadoxine-pyrimethamine; 58-14-0/Pyrimethamine
Comment In:
Lancet. 2010 Jan 9;375(9709):121   [PMID:  20109889 ]
Lancet. 2009 Oct 31;374(9700):1478-80   [PMID:  19765814 ]

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