ATOL: Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00445796
• Collaborator: (none)
• Enrollment: 300
• Locations: 2
• Patients Per Site: 150

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Artesunate; Drug: Amodiaquine	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

1. clinical and parasitological cure on Day 14 []

2. Secondary: incidence and severity of adverse events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Yaounde		Cameroon
2	Sanofi-Aventis	Dakar		Senegal

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Valérie Lameyre, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00445796
• Other Study ID Numbers: PM_L_0163
• First Posted: Mar 9, 2007
• Last Update Posted: Apr 10, 2008
• Last Verified: Apr 1, 2008

• Additional relevant MeSH terms: Malaria; Artesunate; Amodiaquine

Study Results

No Results Posted as of Apr 10, 2008