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A Randomised Trial to Compare the Safety, Tolerability and Efficacy of Three Drug Combinations for Intermittent Preventive Treatment in Children

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  • Kalifa Bojang
  • Francis Akor
  • Ousman Bittaye
  • David Conway
  • Christian Bottomley
  • Paul Milligan
  • Brian Greenwood

Abstract

Background: Results from trials of intermittent preventive treatment (IPT) in infants and children have shown that IPT provides significant protection against clinical malaria. Sulfadoxine-pyrimethamine (SP) given alone or in combination with other drugs has been used for most IPT programmes. However, SP resistance is increasing in many parts of Africa. Thus, we have investigated whether SP plus AQ, SP plus piperaquine (PQ) and dihydroartemisinin (DHA) plus PQ might be equally safe and effective when used for IPT in children in an area of seasonal transmission. Methods: During the 2007 malaria transmission season, 1008 Gambian children were individually randomized to receive SP plus amodiaquine (AQ), SP plus piperaquine (PQ) or dihydroartemisinin (DHA) plus PQ at monthly intervals on three occasions during the peak malaria transmission season. To determine the risk of side effects following drug administration, participants in each treatment group were visited at home three days after the start of each round of drug administration and a side effects questionnaire completed. To help establish whether adverse events were drug related, the same questionnaire was administered to 286 age matched control children recruited from adjacent villages. Morbidity was monitored throughout the malaria transmission season and study children were seen at the end of the malaria transmission season. Results: All three treatment regimens showed good safety profiles. No severe adverse event related to IPT was reported. The most frequent adverse events reported were coughing, diarrhoea, vomiting, abdominal pain and loss of appetite. Cough was present in 15.2%, 15.4% and 18.7% of study subjects who received SP plus AQ, DHA plus PQ or SP plus PQ respectively, compared to 19.2% in a control group. The incidence of malaria in the DHA plus PQ, SP plus AQ and SP plus PQ groups were 0.10 cases per child year (95% CI: 0.05, 0.22), 0.06 (95% CI: 0.022, 0.16) and 0.06 (95% CI: 0.02, 0.15) respectively. The incidence of malaria in the control group was 0.79 cases per child year (0.58, 1.08). Conclusion: All the three regimens of IPT in children were safe and highly efficacious Trial Registration: ClinicalTrials.gov NCT00561899

Suggested Citation

  • Kalifa Bojang & Francis Akor & Ousman Bittaye & David Conway & Christian Bottomley & Paul Milligan & Brian Greenwood, 2010. "A Randomised Trial to Compare the Safety, Tolerability and Efficacy of Three Drug Combinations for Intermittent Preventive Treatment in Children," PLOS ONE, Public Library of Science, vol. 5(6), pages 1-9, June.
    • Handle: RePEc:plo:pone00:0011225
    DOI: 10.1371/journal.pone.0011225
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    References listed on IDEAS

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    1. Margaret Kweku & Dongmei Liu & Martin Adjuik & Fred Binka & Mahmood Seidu & Brian Greenwood & Daniel Chandramohan, 2008. "Seasonal Intermittent Preventive Treatment for the Prevention of Anaemia and Malaria in Ghanaian Children: A Randomized, Placebo Controlled Trial," PLOS ONE, Public Library of Science, vol. 3(12), pages 1-12, December.
    2. Cheikh Sokhna & Badara Cissé & El Hadj Bâ & Paul Milligan & Rachel Hallett & Colin Sutherland & Oumar Gaye & Denis Boulanger & Kirsten Simondon & François Simondon & Geoffrey Targett & Jo Lines & Bria, 2008. "A Trial of the Efficacy, Safety and Impact on Drug Resistance of Four Drug Regimens for Seasonal Intermittent Preventive Treatment for Malaria in Senegalese Children," PLOS ONE, Public Library of Science, vol. 3(1), pages 1-9, January.
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