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Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria

NCT01150344 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2015-12-09

No results posted yet for this study

Summary

Riamet® or Malarone® are both recommended as the first line treatment for uncomplicated malaria in France, according to the French consensus Conference revised in 2007 on the treatment of imported malaria.

The aim of the study is to compare both tolerance and efficacy of Malarone® and Riamet® in the treatment of uncomplicated imported malaria and to determine clinical and parasitological predictive factors associated with a less effectiveness. It's a multicentric, randomised study in adults with uncomplicated malaria. Treatment will be administered for 3 days, and patients will be followed for 28 days, to evaluate the therapeutic evolution. 640 patients will be included among 15 centres.

Conditions

Interventions

DRUG

Malarone (atovaquone + proguanil combination)

4 X (250mg atovaquone + 100 mg proguanil) per os, once a day on 3 days as H0, H24 and H48.

DRUG

RIAMET (artemether + LUMEFANTRIN combination)

4 X (20mg artemether + 120 mg lumefantrine) per os twice a day on 3 days as H0, H8, H24, H36, H48 and H60

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Olivier Bouchaud, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-04-30
Completion
2015-11-30

Countries

  • France

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 NCT01150344 on ClinicalTrials.gov