Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

June 22, 2010 updated by: Sanofi

A Randomized Study to Compare Artesunate + Amiodaquine Versus Artemether + Lumefantrine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During 2 Years in a Cohort in Senegal

Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject.

Secondary objectives:

For the first attack: To compare the two groups of treatment in terms of:

  • D14 efficacy
  • Parasitological and fever clearance
  • Clinical and biological tolerability
  • Evolution of gametocyte carriage
  • Cardiac tolerability (QTc)

For the repeated attacks: To compare the two groups of treatment in terms of:

  • D14 and D28 clinical and parasitological effectiveness (PCR adjusted)
  • Clinical and biological tolerability
  • Proportion of patients without fever at D3
  • Proportion of patients without parasite at D3
  • Compliance
  • Impact on anaemia

During the total follow-up of the cohort: To compare the two groups of treatment in term of:

  • Treatment incidence density
  • Impact of repeated treatment on clinical and biological safety
  • Impact of repeated treatment on hearing capacity

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Senegal
      • Dakar, Senegal
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Lists of Inclusion and Exclusion criteria:

Inclusion Criteria:

  • adults or children weighting more than 5 kg
  • axillary temperature >=37.5°C at D0 or history of fever within the previous 24hrs
  • confirmed Plasmodium falciparum monoinfection, with parasitemia>1000mcl
  • negative urinary pregnancy test for women of child bearing age before each new administration of treatment

Exclusion Criteria:

  • presence of any serious or clinical danger sign of malaria: prostration, consciousness disorders, recent and repeated convulsions, respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic BP< 70 mmHg in adults or < 50 mmHg in children, spontaneous bleeding, inability to sit or stand
  • severe concomitant disease
  • allergy to one of the investigational drugs.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)
Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg
Active Comparator: 2
Drug: Coartem® (arthemether+ lumefantrine)

Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range.

Duration of treatment: 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PCR corrected and uncorrected clinical and parasitological cure rate
Time Frame: at D28 and for the first attack
at D28 and for the first attack

Secondary Outcome Measures

Outcome Measure
Time Frame
PCR corrected and uncorrected clinical and parasitological cure rate
Time Frame: at D28 and for the next attacks
at D28 and for the next attacks
Fever and parasitological clearance
Time Frame: first attack
first attack
Proportion of afebrile patients and proportion of patients without parasites
Time Frame: at D3 for the following attacks
at D3 for the following attacks
Clinical tolerability (incidence and intensity of recorded AE)
Time Frame: during the study period
during the study period
Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count)
Time Frame: during the study period
during the study period
Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years)
Time Frame: at the time of the first attack
at the time of the first attack
Assessment and evolution of hearing function in patients groupe aged >=12 years
Time Frame: during the study period
during the study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Valerie Lemeyre, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimate)

October 8, 2007

Study Record Updates

Last Update Posted (Estimate)

June 23, 2010

Last Update Submitted That Met QC Criteria

June 22, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARAMF_L_02873

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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