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

NCT01136850 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2793

Last updated 2013-04-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Papua New Guinea Institute of Medical Research

    collaborator OTHER_GOV

  • The University of Western Australia

    collaborator OTHER

  • Walter and Eliza Hall Institute of Medical Research

    collaborator OTHER

  • University of Barcelona

    collaborator OTHER

  • University of Melbourne

    lead OTHER

Principal Investigators

  • Stephen J Rogerson, FRACP PhD · University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-12-31
Completion
2013-01-31

Countries

  • Papua New Guinea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01136850 on ClinicalTrials.gov