Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax Malaria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-06-30

Brief Summary

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Primary Objective:

\- To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine

Secondary Objectives:

* To assess the non inferiority on the same way as the main criteria:
* at Day 28 before corrected cure rate
* at Day 14 and Day 42 before and after corrected cure rate
* To compare the two groups of treatment in terms of:
* Efficacy:

* Proportion of aparasitaemic patients at 24, 48 an 72 hours
* Proportion of afebrile patients at 24, 48 and 72 hours
* Percentage of gametocyte carriers during follow-up
* Evolution of the mean of gametocytes during the 42 days of follow-up
* Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28
* Clinical and biological tolerability:

* Proportion of any adverse event
* Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins)
* ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above

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Detailed Description

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Each patient will be followed for a period of 42 days

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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artesunate/amodiaquine

artesunate (AS) / amodiaquine (AQ) as fixed dose combination

1 tablet of AS 25mg/ AQ 67,5mg or AS 50mg/AQ 135mg or AS 100mg/ AQ 270mg or 2 tablets of AS 100mg/ AQ 270mg dose according to bodyweight Once daily 3 days of treatment

Group Type EXPERIMENTAL

ARTESUNATE + AMODIAQUINE

Intervention Type DRUG

Pharmaceutical form:

Route of administration:

chloroquine

150mg tablets 25mg/kg in 3 days (10mg/kg on day 1 and 7,5 mg/kg on days 2 and 3) dose according to bodyweight Once daily 3 days of treatment

Group Type ACTIVE_COMPARATOR

Chloroquine

Intervention Type DRUG

Pharmaceutical form:tablet Route of administration: oral

Interventions

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ARTESUNATE + AMODIAQUINE

Pharmaceutical form:

Route of administration:

Intervention Type DRUG

Chloroquine

Pharmaceutical form:tablet Route of administration: oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults and children over 6 months old and bodyweight \> 5 kg
* Able to be treated by oral route
* Axillary temperature ≥ 37,5 C or history of fever during the previous 2 days
* Symptomatic biologically confirmed Plasmodium vivax mono-infection, with parasitemia from 250 to 100000 parasites /µl of blood
* Written informed consent of the patients and for children written informed consent of the parents/legal representative for children. Children able to understand the objectives and the risks of the study will sign an assent form.

Exclusion Criteria

* Known project of leaving the investigator site area during the follow-up period (42 days)
* Hypersensitivity to one of the investigational medicinal products or to any of the excipients
* Intake of an antimalarial treatment in the previous 30 days
* History of hepatic and (or) haematological impairment during treatment with amodiaquine
* Blurred vision suggesting a retinopathy
* Presence of at least one danger sign of malaria
* Pregnant or breast-feeding women
* Women with childbearing potential not willing to use an effective contraceptive method(s) for the duration of the study
* Known severe concomitant or underlying disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No