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Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria (MalaRia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01150344
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Malaria Drug: Malarone (atovaquone + proguanil combination) Drug: RIAMET (artemether + LUMEFANTRIN combination) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria : a Multicentric Study
Study Start Date : July 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Malarone

Malarone (atovaquone + proguanil combination):

patients treated with Malarone®

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.
Other Name: atovaquone+proguanil combination

Active Comparator: Riamet

RIAMET (artemether + LUMEFANTRIN combination):

patients treated with Riamet®

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
Other Name: artemether+LUMEFANTRIN combination




Primary Outcome Measures :
  1. Number of cases where a second line treatment is used for either intolerance or lack of effectiveness [ Time Frame: within the 28 days after diagnosis of malaria ]

Secondary Outcome Measures :
  1. Parasitological cure rate [ Time Frame: At day 3 ]
  2. Fever clearance [ Time Frame: At day 3 ]
  3. Digestive tolerance [ Time Frame: At day 3 ]
  4. Number of relapses [ Time Frame: At day 3 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

EXCLUSION CRITERIA:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150344


Locations
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France
Hôpital Avicenne
Bobigny, Seine St Denis, France, 93000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Olivier Bouchaud, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01150344    
Other Study ID Numbers: P081222
2010-019950-42 ( EudraCT Number )
First Posted: June 24, 2010    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: October 2015
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Multicentric study
Antimalarial
P. falciparum
Efficacy
Failures
Malarone
RIAMET
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Artemether
Atovaquone
Proguanil
Atovaquone, proguanil drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites