Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

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

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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Primary Objective:

To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day 14, of administration of Arsucam® as a single daily intake versus two daily intakes.

Secondary Objective:

To compare the clinical safety of the two treatment regimens.

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Detailed Description

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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

Interventions

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Artesunate

Intervention Type DRUG

Amodiaquine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* weighing ≥ 10 kg
* residing in the area covered by the investigating centre throughout the entire follow-up period
* axillary temperature ≥ 37.5 degrees Celsius or history of fever within the previous 24 hours
* Plasmodium falciparum density in the blood ranging from 1000 to 100,000 asexual forms per cubic millimetre

Exclusion Criteria

* presence of at least one sign of severe malaria or clinical danger sign : prostration, consciousness disorders, recent and repeated convulsions , respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic Blood Pressure \< 70 mmHg in adults or \< 50 in children, spontaneous bleeding, inability to sit or stand
* serious concomitant disease
* allergy to one of the investigational medicinal products
* pregnant women or breast-feeding women.
* documented intake of an antimalarial at a suitable dosage within seven days prior to inclusion.

Eligible Sex

ALL

Accepts Healthy Volunteers

No