Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan
Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent
preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence
of malaria and anaemia in infants in an area with low SP resistance, low transmission
pressure and high bednet use. However, it is not clear whether this observation can be
generalised to areas with high transmission and high SP resistance. The mechanism of the
protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial
drugs that could be used for IPTi instead of SP.
This study objectives are:
1. Identification of a drug that could be used safely and effectively for IPTi instead of
SP in areas, such as north eastern Tanzania, where there is a high level of resistance
to SP and amodiaquine.
2. Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a
long acting drug (mefloquine) when used for IPTi.
3. Investigation of the effect of the intensity of transmission on the requirements for a
long or short acting drug for IPTi.
4. Assessment of the effect of IPTi on the development of clinical immunity in children in
low and high transmission areas.
A randomised trial with four treatment regimes is proposed which will be conducted in two
different transmission settings. The four treatment regimens are as follows: (1) placebo; (2)
mefloquine; (3) Lapdap; (4) SP. All medications will be given at the time of immunisation
with DPT/polio 2, DPT/polio 3, and measles vaccines. The study will involve 1280 infants in a
high endemic area and 2440 infants in a low endemic area, in Tanzania.The primary outcome is
the incidence of clinical malaria.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Gates Malaria Partnership London School of Hygiene and Tropical Medicine
Collaborators:
Kilimanjaro Christian Medical Centre, Tanzania National Institute for Medical Research, Tanzania University of Copenhagen
Treatments:
Chlorproguanil Dapsone Fanasil, pyrimethamine drug combination Mefloquine Proguanil Pyrimethamine Sulfadoxine