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Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants

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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, John J; Schellenberg, David; Egan, Andrea; Breckenridge, Alasdair; Carneiro, Ilona; Critchley, Julia; Danquah, Ina; Dodoo, Alexander; Kobbe, Robin; Lell, Bertrand; May, Jürgen; Premji, Zul; Sanz, Sergi; Sevene, Esperanza; Soulaymani-Becheikh, Rachida; Winstanley, Peter; Adjei, Samuel; Anemana, Sylvester; Chandramohan, Daniel; Issifou, Saadou; Mockenhaupt, Frank; Owusu-Agyei, Seth; Greenwood, Brian; Grobusch, Martin P; Kremsner, Peter G; Macete, Eusebio; Mshinda, Hassan; Newman, Robert D; Slutsker, Laurence; Tanner, Marcel; Alonso, Pedro; Menendez, Clara.

In: LANCET, Vol. 374, No. 9700, 31.10.2009, p. 1533-42.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Aponte, JJ, 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, MP, Kremsner, PG, Macete, E, Mshinda, H, Newman, RD, Slutsker, L, Tanner, M, Alonso, P & 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, vol. 374, no. 9700, pp. 1533-42. https://doi.org/10.1016/S0140-6736(09)61258-7

APA

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., ... 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), 1533-42. https://doi.org/10.1016/S0140-6736(09)61258-7

Vancouver

Aponte JJ, Schellenberg D, Egan A, Breckenridge A, Carneiro I, Critchley J et al. 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. 2009 Oct 31;374(9700):1533-42. https://doi.org/10.1016/S0140-6736(09)61258-7

Bibtex

@article{30e244233b074fd8bb58d567b3a1ff00,
title = "Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials",
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.",
keywords = "Africa, Anemia, Antimalarials, Double-Blind Method, Drug Administration Schedule, Drug Combinations, Follow-Up Studies, Humans, Immunization Schedule, Incidence, Infant, Infant Mortality, Malaria, Falciparum, Patient Admission, Pyrimethamine, Randomized Controlled Trials as Topic, Regression Analysis, Research Design, Risk Factors, Safety, Sulfadoxine, Treatment Outcome",
author = "Aponte, {John J} and David Schellenberg and Andrea Egan and Alasdair Breckenridge and Ilona Carneiro and Julia Critchley and Ina Danquah and Alexander Dodoo and Robin Kobbe and Bertrand Lell and J{\"u}rgen May and Zul Premji and Sergi Sanz and Esperanza Sevene and Rachida Soulaymani-Becheikh and Peter Winstanley and Samuel Adjei and Sylvester Anemana and Daniel Chandramohan and Saadou Issifou and Frank Mockenhaupt and Seth Owusu-Agyei and Brian Greenwood and Grobusch, {Martin P} and Kremsner, {Peter G} and Eusebio Macete and Hassan Mshinda and Newman, {Robert D} and Laurence Slutsker and Marcel Tanner and Pedro Alonso and Clara Menendez",
year = "2009",
month = oct,
day = "31",
doi = "10.1016/S0140-6736(09)61258-7",
language = "English",
volume = "374",
pages = "1533--42",
journal = "LANCET",
issn = "0140-6736",
publisher = "Elsevier Limited",
number = "9700",

}

RIS

TY - JOUR

T1 - Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants

T2 - a pooled analysis of six randomised, placebo-controlled trials

AU - Aponte, John J

AU - Schellenberg, David

AU - Egan, Andrea

AU - Breckenridge, Alasdair

AU - Carneiro, Ilona

AU - Critchley, Julia

AU - Danquah, Ina

AU - Dodoo, Alexander

AU - Kobbe, Robin

AU - Lell, Bertrand

AU - May, Jürgen

AU - Premji, Zul

AU - Sanz, Sergi

AU - Sevene, Esperanza

AU - Soulaymani-Becheikh, Rachida

AU - Winstanley, Peter

AU - Adjei, Samuel

AU - Anemana, Sylvester

AU - Chandramohan, Daniel

AU - Issifou, Saadou

AU - Mockenhaupt, Frank

AU - Owusu-Agyei, Seth

AU - Greenwood, Brian

AU - Grobusch, Martin P

AU - Kremsner, Peter G

AU - Macete, Eusebio

AU - Mshinda, Hassan

AU - Newman, Robert D

AU - Slutsker, Laurence

AU - Tanner, Marcel

AU - Alonso, Pedro

AU - Menendez, Clara

PY - 2009/10/31

Y1 - 2009/10/31

N2 - 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.

AB - 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.

KW - Africa

KW - Anemia

KW - Antimalarials

KW - Double-Blind Method

KW - Drug Administration Schedule

KW - Drug Combinations

KW - Follow-Up Studies

KW - Humans

KW - Immunization Schedule

KW - Incidence

KW - Infant

KW - Infant Mortality

KW - Malaria, Falciparum

KW - Patient Admission

KW - Pyrimethamine

KW - Randomized Controlled Trials as Topic

KW - Regression Analysis

KW - Research Design

KW - Risk Factors

KW - Safety

KW - Sulfadoxine

KW - Treatment Outcome

U2 - 10.1016/S0140-6736(09)61258-7

DO - 10.1016/S0140-6736(09)61258-7

M3 - SCORING: Journal article

C2 - 19765816

VL - 374

SP - 1533

EP - 1542

JO - LANCET

JF - LANCET

SN - 0140-6736

IS - 9700

ER -