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Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01023399
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : February 23, 2015
Medicines for Malaria Venture
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment Phase
Malaria Drug: Artesunate + Amodiaquine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 580 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2009
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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

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

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01023399

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanofi Identifier: NCT01023399    
Other Study ID Numbers: ARAMF_L_04314
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents