A Trial of Antimalarial Drugs Used in Pregnancy in Tanzania
Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
Participant gender:
Summary
Pregnant women are vulnerable to malaria, with significant implications both for their health
and for the pregnancy. Sulfadoxine-pyrimethamine (SP) is currently the first line drug for
the treatment of malaria in pregnancy in Tanzania and surrounding countries, but resistance
is emerging rapidly. Alternative drugs must be found, and new drugs and drug combinations are
being recommended by many for deployment as first line treatment at the point that SP
resistance forces a policy change. However, there are few data on the safety and efficacy of
these combinations in pregnant women. This randomised trial aims to assess efficacy and
safety, including birth outcome, in pregnant women with malaria in the second or third
trimesters. A total of 900 pregnant women will be randomised either to standard treatment
(SP) or to one of three potential drugs, or drug combinations recently recommended by a WHO
expert panel. These will be SP-amodiaquine, chlorproguanil-dapsone (Lapdap), and
amodiaquine-artesunate. Primary outcome will be treatment failure. Secondary outcomes will
include 28 day slide clearance, maternal side effects, foetal viability and birth outcome.
Phase:
Phase 3
Details
Lead Sponsor:
Gates Malaria Partnership London School of Hygiene and Tropical Medicine