MedTrace Logo

Quinine vs. Artemether/Lumefantrine in Uncomplicated Malaria During Pregnancy

NCT00495508 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-06-03

No results posted yet for this study

Summary

A) for the treatment of uncomplicated malaria during second and third trimester pregnancy to oral Quinine hydrochloride. The PCR-corrected adequate clinical and parasitological response (ACPR) on day 42 is considered as the primary efficacy criterion. Newborns will be followed for growth and development indicators.

Conditions

Interventions

DRUG

Quinine

DRUG

artemether / lumefantrine

Sponsors & Collaborators

  • Medecins Sans Frontieres, Netherlands

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • Shoklo Malaria Research Unit

    collaborator OTHER

  • Epicentre

    lead OTHER

Principal Investigators

  • Patrice Piola, MD, MPH · Epicentre

  • Philippe J Guerin, MD, MPH, PhD · Epicentre

  • Elizabeth Ashley, MB BS · Epicentre

  • Rose McGready, MD, PhD · Shoklo Malaria Research Unit (SMRU)

  • François Nosten, MD, PhD · SMRU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

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 NCT00495508 on ClinicalTrials.gov