Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: Malarone (atovaquone + proguanil combination) (Drug); RIAMET (artemether + LUMEFANTRIN combination) (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s): Olivier Bouchaud, MD, PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
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.
Clinical Details
Official title: Effectiveness and Safety Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria : a Multicentric Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of cases where a second line treatment is used for either intolerance or lack of effectiveness
Secondary outcome: Parasitological cure rateFever clearance Digestive tolerance Number of relapses
Detailed description:
Background : 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. Today no randomized controlled trial (RCT)
comparing both treatments are available for either tolerance or efficacy especially in the
field of imported malaria.
Malarone®, an atovaquone+proguanil combination, has become these last years the most
prescribed treatment in adult in this indication in France. With Malarone®, therapeutic
failures are rare, but digestive side effects are observed, such as vomiting, possibly
leading to the use of a second line treatment.
Riamet®, an artemether+lumefantrine combination, is available in France since only July
2007, but is largely used in endemic areas (as CO-ARTEM). A good tolerance and efficacy are
reported by studies performed in endemic areas.
Both antimalarials are to be taken for a 3-days treatment period, once a day for Malarone®,
but twice a day for Riamet®, which is supposed to affect the observance, on the one hand. On
the other hand, parasitological cure rate and apyrexia occur faster with RIAMETt® than with
Malarone®.
Primary objective: to compare both tolerance et efficacy of Malarone® and RIAMET® in the
treatment of uncomplicated imported malaria.
Secondary objective: to determine clinical and parasitological predictive factors associated
with a less effectiveness.
Primary outcome: 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 outcome: parasitological cure rate at J3, fever clearance, digestive tolerance,
number of relapses.
Design: Multicentric, open-label, randomized, controlled trial of superiority in adults with
uncomplicated malaria and no contraindications to the oral treatment. Treatment will be
administered for 3 days, and patients will be followed for 28 days, according to the
national recommendations, to evaluate the therapeutic evolution. 640 patients will be
included within 36 months. Recruitment will take place among 15 of the corresponding centres
of the Malaria National Reference Centre.
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,
able to come back at J3, J7 and J28, consent to participate.
Non inclusion criteria: pregnancy, ECG abnormality, contraindication to treatment, previous
anti-malaric treatment within 30 days (HALOFANTRIN) or 48 hours (other antimalarial
treatments).
Sample size justification: considering that 13% of patients on Malarone® will be treated by
a second line of treatment, 300 patients per group would be necessary to achieve a relative
reduction of 50% of patients treated by a second line of treatment (i. e. 6,5%) in the
RIAMET® group, with a 80% of statistical power and a type I error rate taken to be 0,05.
Considering 5% of patients lost of follow up, 640 patients have to be included.
Perspectives : these data should help to define the best 1st line of treatment in the
uncomplicated malaria.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hôpital Avicenne, Bobigny, Seine St Denis 93000, France
Additional Information
Starting date: July 2010
Last updated: July 7, 2015
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