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Efficacy and Safety of IPTp-DP Versus IPTp-SP in Malawi

NCT03009526 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2021-07-26

No results posted yet for this study

Summary

This study aims to compare the efficacy of monthly IPTp-DP with monthly IPTp-SP to determine if IPTp-DP is associated with a reduction in malaria infection at delivery among HIV-negative women in an area with high levels of SP resistance in Malawi.

Conditions

Interventions

DRUG

Sulfadoxine-pyrimethamine

500 mg sulfadoxine and 25 mg pyrimethamine

DRUG

dihydroartemisinin-piperaquine

40 mg dihydroartemisinin and 320 mg piperaquine

Sponsors & Collaborators

Principal Investigators

  • Don P Mathanga, MBBS PhD · Malawi College of Medicine

  • Julie Gutman, MD MSc · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-17
Primary Completion
2018-10-24
Completion
2018-10-24

Countries

  • Malawi

Study Locations

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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 NCT03009526 on ClinicalTrials.gov