Conditions: Intermittent Preventive Treatment In Pregnancy (IPTp)
Keywords: P. falciparum malaria IPTp
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2891
Healthy volunteers: yes

Brief summary:
The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.

Detailed description:
After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.

Arms:
arm 1: Azithromycin/chloroquine arm 2: sulfadoxine-pyrimethamine (Fansidar)

Interventions: intervention 1: Azithromycin plus chloroquine intervention 2: sulfadoxine-pyrimethamine
Intervention descriptions: intervention 1: combination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation. intervention 2: Fansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.

Protocol document: