NCT01136850

Intermittent Preventive Treatment With Azithromycin-containing Regimens in Pregnant Women in Papua New Guinea

Intermittent Preventive Treatment With Azithromycin-containing Regimens for the Prevention of Malarial Infections and Anaemia and the Control of Sexually Transmitted Infections in Pregnant Women in Papua New Guinea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,793 (actual)
• Sponsor: University of Melbourne · Academic / Other
• Sex: Female
• Age: 16 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether repeated courses of sulphadoxine-pyrimethamine (SP) in combination with azithromycin given at Antenatal Clinic, leads to lower rates of low birth weight deliveries (\<2.5 kg) among Papua New Guinean women, than the current standard treatment of SP and chloroquine.

Conditions

• Malaria in Pregnancy
• Sexually Transmitted Infections
• Anaemia

Interventions

Type	Name	Description
DRUG	chloroquine, sulphadoxine pyrimethamine, LLIN	\> 50Kg: chloroquine base 150 mg 4 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose. \< 50 Kg: chloroquine base 150 mg 3 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose. Given at enrolment, 14-26 weeks gestation, by mouth.
DRUG	azithromycin, sulphadoxine pyrimethamine, LLIN	sulphadoxine pyrimethamine (1500 mg/75 mg as single dose) plus azithromycin (1 g twice daily for 2 days). Given three times by mouth at monthly intervals, commencing at between 14 and 26 weeks gestation.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2010-06-04
• Last updated: 2013-04-23

Locations

1 site across 1 country: Papua New Guinea