Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

February 20, 2015 updated by: Sanofi

A Nested Open Labeled Study to Compare the Effectiveness and Safety of a Fixed-dose Combination of Artesunate Plus Amodiaquine (ASAQ Winthrop®) in the Unsupervised Treatment of Uncomplicated Plasmodium Falciparum Malaria Attacks in Two Patient Groups Enrolled at Two Year-intervals in a Pilot District of Côte d'Ivoire

The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate plus amodiaquine implementation program and 24 months later.

The secondary objectives are Clinical and biological tolerability Evolution of gametocyte carriage Proportion of patients without fever at Day 3 Proportion of patients without parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite sensibility to amodiaquine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

580

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

  • Côte D'Ivoire
      • Agboville district, Côte D'Ivoire
        • Investigational Site Number 1

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body weight >=5kg
  • Plasmodium falciparum infection with parasite density > 2000/µL
  • Fever or history of fever
  • Able to be treated by oral route
  • No signs of severe malaria
  • No known allergy to study drugs
  • No other severe illnesses or underlying diseases
  • No known pregnancy or negative urinary pregnancy test for women of child bearing age
  • No participation in another ongoing clinical study

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Artesunate + Amodiaquine

Oral fixed combination of artesunate (AS) and amodiaquine (AQ)

Once daily, dose according to age

Infants 2-11 months: AS 25/AQ 67,5 mg (3 tablets/ blister)

Toddlers 1-5 years: AS 50/AQ 135 mg (3 tablets/ blister)

Children: 6-13 years: AS 100/AQ 270 mg (3 tablets/ blister)

Adults: >= 14 years: AS 100/AQ 270 mg (6 tablets/ blister)

3 day-treatment
Drug: Artesunate + Amodiaquine
Artesunate + Amodiaquine fixed dose combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR)
Time Frame: Day 28
Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients without fever
Time Frame: Day 3
Day 3
Number of patients without parasite
Time Frame: Day 3
Day 3
Number of gametocytes
Time Frame: Day 3, Day 7, Day 14, Day 21 and Day 28
Day 3, Day 7, Day 14, Day 21 and Day 28
Evolution of in vitro resistance rate
Time Frame: Day 3, Day 7, Day 14, Day 21 and Day 28
Day 3, Day 7, Day 14, Day 21 and Day 28

Collaborators and Investigators

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

Sponsor

Sanofi

Collaborators

Medicines for Malaria Venture

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

November 1, 2009

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (ESTIMATE)

December 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 20, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARAMF_L_04314

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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