Skip to main content
OpenTrials
Completed

NCT Number: NCT01023399

Artesunate Plus Amodiaquine in Malaria in Cote 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number 1

Agboville District, Côte d’Ivoire

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artesunate + Amodiaquine

Drug

Artesunate + Amodiaquine fixed dose combination

Primary outcomes

  1. Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR)

    Time frame: Day 28

Secondary outcomes

  1. Number of patients without fever

    Time frame: Day 3

  2. Number of patients without parasite

    Time frame: Day 3

  3. Number of gametocytes

    Time frame: Day 3, Day 7, Day 14, Day 21 and Day 28

  4. Evolution of in vitro resistance rate

    Time frame: Day 3, Day 7, Day 14, Day 21 and Day 28

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Medicines for Malaria Venture

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Dec 2, 2009
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.