Authors

J.J. Aponte, University of Barcelona
D. Schellenberg, London School of Hygiene and Tropical Medicine
A. Egan, University of Barcelona
A. Breckenridge, Medicines and Healthcare Products Regulatory Agency, London
I. Carneiro, London School of Hygiene and Tropical Medicine
J. Critchley, University of Newcastle
I. Danquah, Charité-University Medicine Berlin
A. Dodoo, University of Ghana Medical School
R. Kobbe, Bernhard Nocht Institute for Tropical Medicine
B. Lell, University of Tübingen
J. May, Bernhard Nocht Institute for Tropical Medicine
Zul Premji, Aga Khan UniverstiyFollow
S. Sanz, University of Barcelona
E. Sevene, Eduardo Mondlane University
R. Soulaymani-Becheikh, Centre Anti-poisons et de Pharmacovigilance du Maroc
P. Winstanley, University of Liverpool
S. Adjei, Ministry of Health/Ghana Health Service
S. Anemana, Ministry of Health/Ghana Health Service
D. Chandramohan, London School of Hygiene and Tropical Medicine
S. Issifou, University of Tübingen
F. Mockenhaupt F., Charité-University Medicine Berlin
S. Owusu-Agyei, Ministry of Health/Ghana Health Service
B. Greenwood, London School of Hygiene and Tropical Medicine
M.P. Grobusch, University of Witwatersrand
P.G. Kremsner, University of Tübingen
E. Macete, Centro de Investigação em Saude de Manhiça
H. Mshinda, Ifakara Health Research Development Centre
R.D. Newman, Centers for Disease Control and Prevention, Atlanta
L. Slutsker, Centers for Disease Control and Prevention, Atlanta
M. Tanner, Swiss Tropical Institute
P. Alonso, University of Barcelona
C. Menendez, University of Barcelona

Document Type

Article

Department

Pathology (East Africa)

Abstract

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. © 2009 Elsevier Ltd. All rights reserved.

Publication

The Lancet

Included in

Pathology Commons

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