Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Malaria

Intervention / Treatment
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* Drug: Artesunate + Amodiaquine


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artesunate + Amodiaquine<br>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<br>* Artesunate + Amodiaquine fixed dose combination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR) |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |