Daily Co-trimoxazole Prophylaxis to Prevent Malaria in Pregnancy
Status:
Terminated
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
Summary
Malaria is a major contributor of disease burden in Sub-Saharan Africa, and pregnant women
and children are the most vulnerable population. Malaria in pregnancy increases the risks of
abortion, prematurity, maternal anaemia, low birth weight (LBW), perinatal, neonatal and
infant mortality. For prevention and control of malaria in pregnancy, Intermittent Preventive
Treatment (IPT), insecticide treated nets (ITNs) and case management for malaria and anemia
are recommended.
HIV infection in pregnancy increases the risk of malaria, LBW, post-natal mortality and also
of anaemia. In pregnant women, HIV infection decreases the efficacy of IPT with the medicine
sulfadoxine-pyrimethamine (SP), which is the only treatment with proven efficacy and safety
in IPT and is recommended by the World Health Organization (WHO). Unfortunately, there is a
documented increase of resistance to SP, so cotrimoxazole (CTX) could be an alternative: many
studies in Zambia and Uganda demonstrated that it reduces mortality and morbidity in HIV
infected persons, and CTX prophylaxis significantly improves birth outcomes in
immuno-suppressed HIV women. Unfortunately, there is not yet information on its effectiveness
for preventing placental malaria infection, maternal anaemia and LBW. Thus in this study, we
aim to establish the safety and efficacy of daily CTX in preventing malaria infection during
pregnancy and its consequences, both in HIV infected and non-infected pregnant women. This
information is urgently needed to assist to issue guidelines on IPT in pregnancy.
Phase:
Phase 3
Details
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborator:
Tropical Diseases Research Centre, Zambia
Treatments:
Fanasil, pyrimethamine drug combination Pyrimethamine Sulfadoxine Trimethoprim, Sulfamethoxazole Drug Combination