At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 2,793 enrolled

Drug / intervention

chloroquine, sulphadoxine pyrimethamine, LLIN +1 moredrug

Likely dose

chloroquine, sulphadoxine pyrimethamine, LLIN 150 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01136850

NCT01136850Phase 3Completed

Compare CT.gov

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

University of Melbourne·interventional·Posted Jun 4, 2010·Updated Apr 23, 2013

In Brief

A Phase 3 clinical trial evaluating chloroquine, sulphadoxine pyrimethamine, LLIN and azithromycin, sulphadoxine pyrimethamine, LLIN for Malaria in Pregnancy and 2 related conditions. Completed, enrolled 2,793 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMalaria in Pregnancy, Sexually Transmitted Infections, Anaemia

CountriesPapua New Guinea

CollaboratorsPapua New Guinea Institute of Medical Research, The University of Western Australia, Walter and Eliza Hall Institute of Medical Research, University of Barcelona

Timeline

Phase 3CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartNov 2009

First PostedJun 2010

Primary CompletionDec 2012

Study CompletionJan 2013

TodayJul 2026

First PostedJun 4, 2010

Enrollment StartNov 1, 2009

Primary CompletionDec 1, 2012

Study CompletionJan 1, 2013

TodayJul 2, 2026

Enrollment to primary: 3.1 yearsPosted 16.1 years ago

Interventions

chloroquine, sulphadoxine pyrimethamine, LLINdrug

\> 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.

azithromycin, sulphadoxine pyrimethamine, LLINdrug

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.