Back to resultsArsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance (ATOL)
Primary Purpose
Malaria
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Artesunate
Amodiaquine
Sponsored by
About this trial
This is an interventional treatment trial for Malaria
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.
Sites / Locations
- Sanofi-Aventis
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
clinical and parasitological cure on Day 14
Secondary: incidence and severity of adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00445796
Brief Title
Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Artesunate
Intervention Type
Drug
Intervention Name(s)
Amodiaquine
Primary Outcome Measure Information:
Title
clinical and parasitological cure on Day 14
Title
Secondary: incidence and severity of adverse events
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Lameyre
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Yaounde
Country
Cameroon
Facility Name
Sanofi-Aventis
City
Dakar
Country
Senegal
12. IPD Sharing Statement
Learn more about this trial
Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance
We'll reach out to this number within 24 hrs