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Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

This study has been completed.
Sponsor:
Collaborator:
Medicines for Malaria Venture
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01023399
First received: December 1, 2009
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 in the Treatment of Uncomplicated Plasmodium Falciparum Malaria Attacks

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients without fever [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Number of patients without parasite [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Number of gametocytes [ Time Frame: Day 3, Day 7, Day 14, Day 21 and Day 28 ] [ Designated as safety issue: No ]
  • Evolution of in vitro resistance rate [ Time Frame: Day 3, Day 7, Day 14, Day 21 and Day 28 ] [ Designated as safety issue: No ]

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023399

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01023399     History of Changes
Other Study ID Numbers: ARAMF_L_04314
Study First Received: December 1, 2009
Last Updated: November 4, 2013
Health Authority: Cote d'Ivoire: National Research and Ethics Committee

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections
Amodiaquine
Artesunate
Amebicides
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014