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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Melbourne
• Collaborators: Papua New Guinea Institute of Medical Research; The University of Western Australia; University of Barcelona; Walter and Eliza Hall Institute of Medical Research
• Treatments: Azithromycin; Chloroquine; Chloroquine diphosphate; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• pregnant

• 14-26 weeks'gestation

• permanent resident of study area

• exclusive use of study health facilities for primary health care

• Age is between 16 and 49 years

Exclusion Criteria:

• Known chronic illness, e.g. TB, diabetes, renal failure

• Severe anaemia requiring hospitalisation (Hb < 6 g/dl accompanied by symptoms requiring urgent treatment)

• permanent disability, that prevents or impedes study participation and/or comprehension

• Known multiple pregnancy