Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

Phase 4

Completed

• Conditions: Malaria

• Registration Number: NCT00445796
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2007-03-08
• Study First Submitted QC: 2007-03-08
• Study First Posted: 2007-03-09
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-08
• Last Update Posted: 2008-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
clinical and parasitological cure on Day 14
Secondary: incidence and severity of adverse events

Trial Locations

Locations (1)

Sanofi-Aventis; 🇸🇳 Dakar, Senegal