Malaria Clinical Trial
Official title:
A Pilot Randomized Controlled Trial of Azithromycin or Artesunate Added to Sulphadoxine Pyrimethamine as Therapy for Malaria in Pregnancy
The purpose of this study is to compare the efficacy and safety of three treatment regimens for the prevention of malaria during pregnancy.
Malaria infection during pregnancy poses substantial risk to the mother, her fetus, and the
neonate. Prevention of malaria during pregnancy is vital in decreasing maternal and child
mortality in Africa. There are data from studies that show that intermittent preventive
treatment (IPT) with two doses of sulfadoxine-pyrimethamine (SP) is safe, efficacious, and
effective in preventing maternal anemia, placental parasitemia, and LBW. Resistance to SP,
however, is increasing rapidly in Africa and there is an urgent need to find alternative
effective, safe and affordable drugs for the treatment and prevention of malaria in
pregnancy.
The investigators conducted a trial to determine the efficacy and safety of azithromycin and
artesunate combined with sulphadoxine-pyrimethamine as treatment against malaria during
pregnancy.Pregnant women 14 to 26 weeks gestation with P. falciparum parasitemia on
peripheral blood film were randomly assigned into 3 treatment groups and received two doses
of:(1) SP (3 tablets) only; (2) SP and azithromycin (1gram/day x 2 days)and (3) SP and
artesunate 200mg/day for 3 days). The two doses of the study drug were administered
approximately 4 weeks apart. All study drugs were taken under observation.Blood samples were
collected on days 1, 2, 3, 7 and 14 after treatment and at any visit when the women
presented with symptoms of malaria. The women were also given an insecticide-treated net
(ITN) and followed until delivery. Adverse effects were assessed at each scheduled visit,
any unscheduled visits during the study, and at delivery. Peripheral and placental blood
films and placental biopsies were prepared at delivery. Newborns were weighed, examined, and
gestational age was determined.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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