drugset / Trial / NCT01103713

Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa

NCT01103713

Phase 3 Terminated 168 enrolled Pfizer
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The study will be conducted in asymptomatic pregnant women with P. falciparum parasitemia. The subjects will be given 3 day dosing regiment of the fixed-dose combination of Azithromycin and Chloroquine. Parasitological clearance rate with polymerase chain reaction data will be evaluated on Day 28 as primary endpoint.

Timeline

Start
2011-03
Primary completion
2013-06
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 1000 mg Oral
Subject Chloroquine Small molecule 620 mg Oral

Indications