Abstract
BackgroundResults 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.MethodsDuring 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.ResultsAll 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).ConclusionAll the three regimens of IPT in children were safe and highly efficaciousTrial RegistrationClinicalTrials.gov NCT00561899
Highlights
Significant advances have been made in controlling malaria during the last two decades, the disease remains a major cause of mortality and morbidity in sub-Saharan Africa
The most important recent steps in improving malaria control include the introduction of artemisinin-based combination therapy (ACT), intermittent preventive treatment (IPT) in pregnancy and increased coverage with insecticide-treated bednets (ITNs)
The first dose of IPT treatment was given between 13–24 September 2007, the second dose between 16–26 October and the final dose between 13–24 Novembers
Summary
Significant advances have been made in controlling malaria during the last two decades, the disease remains a major cause of mortality and morbidity in sub-Saharan Africa. The most important recent steps in improving malaria control include the introduction of artemisinin-based combination therapy (ACT), intermittent preventive treatment (IPT) in pregnancy and increased coverage with ITNs. malaria is still estimated to cause directly nearly one million deaths a year and the vast majority of deaths occur among young children, especially among those living in remote rural areas of Africa [1]. The strategy of intermittent preventive treatment (IPT) has become an integral part of malaria control in pregnancy. IPT in infants was endorsed by WHO as a recommended malaria control strategy in areas with moderate or high transmission and a low prevalence of resistance to sulphadoxine/pyrimethamine (SP). Results from trials of intermittent preventive treatment (IPT) in infants and children have shown that IPT provides significant protection against clinical malaria. We have investigated whether SP plus AQ, SP plus piperaquine (PQ) and dihydroartemisinin (DHA) plus PQ might be safe and effective when used for IPT in children in an area of seasonal transmission
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