Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

Phase 4

Completed

• Conditions: Malaria
• Interventions: Drug: Artesunate + Amodiaquine

• Registration Number: NCT01023399
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Artesunate + Amodiaquine	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

Primary Outcome Measures

Name	Time	Method
Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR)	Day 28

Secondary Outcome Measures

Name	Time	Method
Evolution of in vitro resistance rate	Day 3, Day 7, Day 14, Day 21 and Day 28
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

Trial Locations

Locations (1)

Investigational Site Number 1; 🇨🇮 Agboville district, Côte D'Ivoire