Back to resultsACT MALI: Treatment of Malaria Based on Combination Therapies
Primary Purpose
Malaria
Status
Completed
Phase
Phase 4
Locations
Mali
Study Type
Interventional
Intervention
Artesunate
Artesunate + Sulfadoxine-Pyrimethamine
arthemether + lumefantrine
Sponsored by
About this trial
This is an interventional treatment trial for Malaria
Eligibility Criteria
Inclusion Criteria:
- Body weight > 5kg
- Residence in the investigator site area for the duration of the trial
- Axillary temperature ≥ 37,5°C at Day 0
- Confirmed Plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood
Exclusion Criteria:
- Danger signs or signs of severe malaria
- Other severe illnesses
- Allergy to one of the drugs
- Pregnant women
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Arsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment
Arsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os
Coartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days
Outcomes
Primary Outcome Measures
Clinical and parasitological cure rate
Clinical and biological tolerability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00452907
Brief Title
ACT MALI: Treatment of Malaria Based on Combination Therapies
Official Title
Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia
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
780 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Arsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
Arsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os
Arm Title
3
Arm Type
Active Comparator
Arm Description
Coartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days
Intervention Type
Drug
Intervention Name(s)
Artesunate
Intervention Description
oad, per os, 3 days of treatment
Intervention Type
Drug
Intervention Name(s)
Artesunate + Sulfadoxine-Pyrimethamine
Intervention Description
oad, per os
Intervention Type
Drug
Intervention Name(s)
arthemether + lumefantrine
Intervention Description
bid, per os. Duration of treatment: 3 days
Primary Outcome Measure Information:
Title
Clinical and parasitological cure rate
Time Frame
at day 28
Title
Clinical and biological tolerability
Time Frame
During the study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body weight > 5kg
Residence in the investigator site area for the duration of the trial
Axillary temperature ≥ 37,5°C at Day 0
Confirmed Plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood
Exclusion Criteria:
Danger signs or signs of severe malaria
Other severe illnesses
Allergy to one of the drugs
Pregnant women
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 Administrative Office
City
Bougoula
Country
Mali
12. IPD Sharing Statement
Learn more about this trial
ACT MALI: Treatment of Malaria Based on Combination Therapies
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