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Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials.

Aponte, J. J., Schellenberg, D., Egan, A., Breckenridge, A., Carneiro, I., Critchley, J., Danquah, I., Dodoo, A., Kobbe, R., Lell, B., May, J., Premji, Z., Sanz, S., Sevene, E., Soulaymani-Becheikh, R., Winstanley, P., Adjei, S., Anemana, S., Chandramohan, D., Issifou, S., Mockenhaupt, F., Owusu-Agyei, S., Greenwood, B., Grobusch, M. P., Kremsner, P. G., Macete, E., Mshinda, H., Newman, R. D., Slutsker, L., Tanner, M., Alonso, P. and Menendez, C. (2009) Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials. Lancet, 374 (9700). pp. 1533-1542. ISSN 1474-547X

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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.

Item Type: Article
Keywords: preventive treatment, sulfadoxine-pyrimethamine, Malaria, Africa, infant
Subjects: Biomedical Science > Immunology
Malaria > Surveillance, monitoring, evaluation
Malaria > Vaccines
Divisions: Ifakara Health Institute > Biomedical
Depositing User: Mr Joseph Madata
Date Deposited: 25 Jul 2012 20:39
Last Modified: 16 Aug 2012 15:57
URI: http://ihi.eprints.org/id/eprint/229

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