Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT01023399

Collaborator

Medicines for Malaria Venture (Other)

580

Enrollment

Location

Arm

Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Nov 1, 2009

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR) [Day 28]

Secondary Outcome Measures

Number of patients without fever [Day 3]
Number of patients without parasite [Day 3]
Number of gametocytes [Day 3, Day 7, Day 14, Day 21 and Day 28]
Evolution of in vitro resistance rate [Day 3, Day 7, Day 14, Day 21 and Day 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 1	Agboville district		Côte D'Ivoire

Sponsors and Collaborators

Sanofi
Medicines for Malaria Venture

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT01023399

Other Study ID Numbers:

ARAMF_L_04314

First Posted:

Dec 2, 2009

Last Update Posted:

Feb 23, 2015

Last Verified:

Feb 1, 2015

Additional relevant MeSH terms:

Malaria

Artesunate

Amodiaquine

Study Results

No Results Posted as of Feb 23, 2015