Comparison of Three Drug Combinations for Intermittent Treatment of Malaria in Children
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
Intermittent preventive treatment (IPT) offers a way of preventing malaria infection without
compromising the development of malaria immunity or encouraging drug resistance. The effect
of IPT in children in the prevention of malaria has been evaluated in a number of trials in
areas of seasonal malaria transmission. Results from these trials have shown that IPTc
provided between 40% - 86% protection against clinical malaria. In 2006, a trial that
compared two methods of IPTc delivery was carried out in Upper River Division, The Gambia.
Preliminary results of the trial have shown that the treatment was very effective as only 4%
(45/1133) of the children seen at the end of year cross-sectional survey were parasitaemic.
Tolerability was assessed in a subset of 1100 children and the results showed that about
13.5% of children developed mild to moderate vomiting. Malaise was present in about 10% of
the study subjects. Severe adverse events were rare. Thus it is important to investigate if
other drug regimens might be equally effective in preventing malaria but less likely to cause
adverse events. During the 2007 malaria transmission season, 1009 children aged 1-5 years
will be individually randomized to receive amodiaquine plus SP, piperaquine plus SP or
Artekin TM (dihdroartemisinin plus piperaquine) at monthly intervals on three occasions
during the months of September, October, and November. To determine the prevalence of side
effects following drug administration participants in each treatment group will be visited at
home three and seven days after each round of drug administration and a side effects
questionnaire completed. To help establish whether these adverse events are drug related, the
same questionnaire will be administered after each treatment round, to 286 age-matched
children who are not part of the trial. The primary ends points will be the incidence of
adverse events.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Gates Malaria Partnership London School of Hygiene and Tropical Medicine
Collaborators:
Department of State for Health and Social Welfare, The Gambia London School of Hygiene and Tropical Medicine