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Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy

NCT00164255 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1614

Last updated 2012-09-11

No results posted yet for this study

Summary

This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.

Conditions

Interventions

DRUG

sulfadoxine/pyrimethamine

DRUG

sulfadoxine/pyrimethamine plus artesunate

Sponsors & Collaborators

Principal Investigators

  • John MacArthur, MD, MPH · Centers for Disease Control and Prevention

  • Salim Abdulla, MD, PhD · Ifakara Health Research and Development Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Diseases
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 NCT00164255 on ClinicalTrials.gov