Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

Malaria Clinical Trial

— ATOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445796
• Other study ID #: PM_L_0163
• Status: Completed
• Phase: Phase 4
• First received: March 8, 2007
• Last updated: April 8, 2008
• Start date: June 2005

Study information

• Verified date: April 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Senegal: Ministere de la sante
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Artesunate

• Amodiaquine

Locations

Country	Name	City	State
Cameroon	Sanofi-Aventis	Yaounde
Senegal	Sanofi-Aventis	Dakar

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Cameroon,  Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical and parasitological cure on Day 14
Primary	Secondary: incidence and severity of adverse events