Advertisement

Topics

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

2014-08-27 03:12:42 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Imported Malaria

Intervention

Malarone (atovaquone + proguanil combination), Riamet (artemether + lumefantrin combination)

Location

Hôpital Avicenne
Bobigny
Seine St Denis
France
93000

Status

Not yet recruiting

Source

Assistance Publique - Hôpitaux de Paris

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:42-0400

Clinical Trials [2097 Associated Clinical Trials listed on BioPortfolio]

Weekly Dosing of Malarone ® for Prevention of Malaria

The purpose of this study is to determine whether Malarone ®, which is a drug approved to prevent malaria when taken daily, will still effectively prevent malaria if taken weekly.

Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.

Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America

The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to atovaquone-proguanil for the treatment of symptomatic, uncomplicated malaria due to...

Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function

To evaluate the potential effects of artemether- lumefantrine on the auditory function

Chloroquine Alone or in Combination for Malaria in Children in Malawi

Malaria is a sickness caused by a germ that can get into a person's body when a mosquito bites them. It can cause fever, headache, body aches and weakness. It can even cause death, especia...

PubMed Articles [424 Associated PubMed Articles listed on BioPortfolio]

Clinical implications of Plasmodium resistance to atovaquone/proguanil: a systematic review and meta-analysis.

Atovaquone/proguanil, registered as Malarone®, is a fixed-dose combination recommended for first-line treatment of uncomplicated Plasmodium falciparum malaria in non-endemic countries and its prevent...

Vivax malaria chemoprophylaxis: the role of Atovaquone-proguanil, compared to other options.

Atovaquone-Proguanil is considered causal prophylaxis (inhibition of liver-stage schizonts) for Plasmodium falciparum, however, its causal prophylactic efficacy for P. vivax is not known. Travelers re...

Acute malaria infection after atovaquone-proguanil prophylaxis.

On the Design of Combination Cancer Therapy.

Combination therapy programs are the hallmark of the successful treatment of all forms of human malignancies. In this issue of Cell, Palmer and Sorger present data suggesting that cell culture results...

Taxane-based Combination Therapies for Metastatic Prostate Cancer.

Multiple single-agent therapies improving survival are approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC), including two chemotherapies, two androgen-signaling axis-...

Medical and Biotech [MESH] Definitions

Inhibitor or Reverse Transcriptases or of RNA-dIrected DNA polymerase.

Therapy with two or more separate preparations given for a combined effect.

A pharmaceutical preparation of ezetimibe and simvastatin that is used in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.

A pharmaceutical preparation of amlodipine and valsartan that is used for the treatment of HYPERTENSION.

A pharmaceutical preparation of emtricitabine and tenofovir that is used as an ANTI-HIV AGENT in the treatment and prevention of HIV INFECTIONS.

More From BioPortfolio on "Evaluation of the Riamet® Versus Malarone® in the Treatment of Uncomplicated Malaria"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...

Malaria
Malaria is a serious tropical disease spread by mosquitoes. If malaria is not diagnosed and treated promptly, it can be fatal. What causes malaria? Malaria is caused by a type of parasite known as Plasmodium. There are many different types of Plasmod...


Searches Linking to this Trial