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Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

This study has been completed.
Medicines for Malaria Venture
Information provided by (Responsible Party):
Sanofi Identifier:
First received: December 1, 2009
Last updated: February 20, 2015
Last verified: February 2015

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

Condition Intervention Phase
Malaria Drug: Artesunate + Amodiaquine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR) [ Time Frame: Day 28 ]

Secondary Outcome Measures:
  • Number of patients without fever [ Time Frame: Day 3 ]
  • Number of patients without parasite [ Time Frame: Day 3 ]
  • Number of gametocytes [ Time Frame: 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 ]

Enrollment: 580
Study Start Date: November 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT01023399

Côte D'Ivoire
Investigational Site Number 1
Agboville district, Côte D'Ivoire
Sponsors and Collaborators
Medicines for Malaria Venture
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT01023399     History of Changes
Other Study ID Numbers: ARAMF_L_04314
Study First Received: December 1, 2009
Last Updated: February 20, 2015

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials processed this record on June 23, 2017