Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

PHASE3TerminatedINTERVENTIONAL
Enrollment

2,891

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

October 31, 2013

Study Completion Date

November 30, 2013

Conditions
Intermittent Preventive Treatment In Pregnancy (IPTp)
Interventions
DRUG

Azithromycin plus chloroquine

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.

DRUG

sulfadoxine-pyrimethamine

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.

Trial Locations (9)

1903

Bugando Medical Centre, Mwanza

Unknown

Centre de Santé d'AHOUANSORI-AGUE, Cotonou

Hôpital Bethesda, Cotonou

Siaya District Hospital, Siaya

Zomba Central Hospital, Zomba

Teule Hospital, Muheza

Nyamagana District Hospital, Mwanza

Nyamagana District Hospital, c/o National Institute for Medical Research, Mwanza Centre, Mwanza

Mulago Hospital Complex, Kampala

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

London School of Hygiene and Tropical Medicine

OTHER

collaborator

Medicines for Malaria Venture

OTHER

lead

Pfizer

INDUSTRY