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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01150344
First received: June 18, 2010
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Malaria
Drug: Malarone (atovaquone + proguanil combination)
Drug: RIAMET (artemether + LUMEFANTRIN combination)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parasitological cure rate [ Time Frame: At day 3 ] [ Designated as safety issue: No ]
  • Fever clearance [ Time Frame: At day 3 ] [ Designated as safety issue: No ]
  • Digestive tolerance [ Time Frame: At day 3 ] [ Designated as safety issue: No ]
  • Number of relapses [ Time Frame: At day 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 640
Study Start Date: July 2010
Estimated Study Completion Date: October 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150344

Locations
France
Hôpital Avicenne
Bobigny, Seine St Denis, France, 93000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Olivier Bouchaud, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01150344     History of Changes
Other Study ID Numbers: P081222, 2010-019950-42
Study First Received: June 18, 2010
Last Updated: June 13, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Multicentric study
Antimalarial
P. falciparum
Efficacy
Failures
Malarone
RIAMET

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Proguanil
Artemether
Atovaquone
Malarone
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014