Table 1 Overview of the study

Study title

A Phase 3, Open-label, Randomized, Comparative Study to Evaluate Azithromycin plus Chloroquine and Sulfadoxine plus Pyrimethamine Combinations for Intermittent Preventive Treatment of Falciparum Malaria Infection in Pregnant Women in Africa

ClinicalTrial.gov identifier

NCT01103063

Primary objective

The primary objective was to establish superiority of AZCQ over SP in protective efficacy for intermittent preventative treatment in pregnancy (IPTp) as measured by the proportion of subjects with sub-optimal pregnancy outcome defined as any of the following: low-birth-weight live birth, premature birth, abortion, still birth, lost to follow-up prior to delivery or termination of pregnancy, or missing birth weight of the neonate

Key secondary objectives

1. Proportion of subjects with low-birth-weight live neonates

2. Proportion of subjects with severe anemia

3. Proportion of subjects with anemia

4. Proportion of subjects with placental parasitemia

5. Occurrence of sexually transmitted infections

6. Safety and tolerability of the two treatment regimens

7. Presence of subjects with a sub-optimal pregnancy outcome including those characteristics described in the primary outcome with the addition of neonatal deaths and congenital malformations

Study sites

Cotonou, Benin; Siaya, Kenya; Zomba, Malawi; Muheza, Tanga, Tanzania; Mwanza, Tanzania; and Kampala, Uganda

Subjects

Pregnant women age 16 years to 35 years

Study drugs

AZCQ 250 mg/155 mg QD for 3 days (3 treatments at 4–8-week intervals)

SP 500 mg/25 mg QD (3 treatments at 4–8-week intervals)