Randomised, Comparative Study of the Efficacy and Safety of Arsucam® Administered as a Single Daily Intake Versus Two Daily Intakes in the Treatment of Plasmodium Falciparum Malaria Attack

Sanofi1 site in 1 country300 target enrollmentJune 2005

ConditionsMalaria

DrugsArtesunate Amodiaquine

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Malaria
Sponsor: Sanofi
Enrollment: 300
Locations: 1
Primary Endpoint: clinical and parasitological cure on Day 14
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

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.