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Cluster randomised trial of intermittent preventive treatment for malaria in infants in area of high, seasonal transmission in Ghana

BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7519.727 (Published 29 September 2005) Cite this as: BMJ 2005;331:727
  1. Daniel Chandramohan, clinical senior lecturer (daniel.chandramohan{at}lshtm.ac.uk)1,
  2. Seth Owusu-Agyei, director2,
  3. Ilona Carneiro, lecturer1,
  4. Timothy Awine, research officer3,
  5. Kwame Amponsa-Achiano, research physician3,
  6. Nathan Mensah, data manager3,
  7. Shabbar Jaffar, senior lecturer1,
  8. Rita Baiden, research physician3,
  9. Abraham Hodgson, director3,
  10. Fred Binka, executive director4,
  11. Brian Greenwood, director,director, Gates Malaria Partnership1
  1. 1 London School of Hygiene and Tropical Medicine, London WC1E 7HT
  2. 2 Kintampo Health Research Centre, Kintampo, Ghana,
  3. 3Navrongo Health Research Centre, Navrongo, Ghana
  4. 4 INDEPTH-Network, Accra, Ghana
  1. Correspondence to: D Chandramohan

    Abstract

    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 (≥ 5000 parasites/μl) 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.

    Footnotes

    • Embedded Image A figure and three tables are on bmj.com

    • Contributors DC was involved in protocol development, implementation of the trial, data analysis, and drafting the manuscript; he is the guarantor. SO-A and FB were involved in protocol development, implementation of the trial, and reviewing the manuscript. IC was involved in data analysis and drafting the manuscript. TA and NM were involved in implementation of the trial, data management, and reviewing the manuscript. KA-A, RB, and AH were involved in implementation of the trial and reviewing the manuscript. SJ was involved in randomisation, data analysis, and reviewing the manuscript. BG was involved in protocol development, monitoring of the trial, data analysis, and drafting the manuscript.

    • Funding This study was funded by a grant from the Department for International Development (DFID) UK (grant No R7602). The analytical plan and the manuscript were not influenced by the DFID. The DFID cannot accept any responsibility for the information and views presented in this manuscript. The subsidiary study of sensitivity of malaria parasites to sulfadoxine-pyrimethamine was funded by the Gates Malaria Partnership.

      Competing interest statement: None declared.

    • Ethical approval The study was approved by the ethical committees of the Ministry of Health of Ghana and the London School of Hygiene and Tropical Medicine.

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