Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria
MalaRia
Effectiveness and Safety Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria : a Multicentric Study
2 other identifiers
interventional
317
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2010
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2010
CompletedFirst Posted
Study publicly available on registry
June 24, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedDecember 9, 2015
October 1, 2015
3.8 years
June 18, 2010
December 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of cases where a second line treatment is used for either intolerance or lack of effectiveness
within the 28 days after diagnosis of malaria
Secondary Outcomes (4)
Parasitological cure rate
At day 3
Fever clearance
At day 3
Digestive tolerance
At day 3
Number of relapses
At day 3
Study Arms (2)
Malarone
ACTIVE COMPARATORMalarone (atovaquone + proguanil combination): patients treated with Malarone®
Riamet
ACTIVE COMPARATORRIAMET (artemether + LUMEFANTRIN combination): patients treated with Riamet®
Interventions
4 X (250mg atovaquone + 100 mg proguanil) per os, once a day on 3 days as H0, H24 and H48.
4 X (20mg artemether + 120 mg lumefantrine) per os twice a day on 3 days as H0, H8, H24, H36, H48 and H60
Eligibility Criteria
You may qualify if:
- subjects aged more than 18,
- back from an endemic area with a positive diagnosis of Plasmodium falciparum by microscopic blood (thin and thick film) examination,
- absence of any severe manifestation according to the WHO definition of severe falciparum malaria
You may not qualify if:
- pregnancy,
- ECG abnormality,
- contraindication to treatment,
- previous anti-malaric treatment within 30 days,
- unable to come back at J3, J7 and J28,
- unwilling to consent to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Avicenne
Bobigny, Seine St Denis, 93000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier Bouchaud, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2010
First Posted
June 24, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2014
Study Completion
November 1, 2015
Last Updated
December 9, 2015
Record last verified: 2015-10