ACT MALI: Treatment of Malaria Based on Combination Therapies
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00452907
First received: March 27, 2007
Last updated: February 16, 2010
Last verified: February 2010
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria |
Drug: Artesunate Drug: Artesunate + Sulfadoxine-Pyrimethamine Drug: arthemether + lumefantrine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Clinical and parasitological cure rate [ Time Frame: at day 28 ]
- Clinical and biological tolerability [ Time Frame: During the study period ]
| Enrollment: | 780 |
| Study Start Date: | July 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Arsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment
|
Drug: Artesunate
oad, per os, 3 days of treatment
|
|
Active Comparator: 2
Arsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os
|
Drug: Artesunate + Sulfadoxine-Pyrimethamine
oad, per os
|
|
Active Comparator: 3
Coartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days
|
Drug: arthemether + lumefantrine
bid, per os. Duration of treatment: 3 days
|
Eligibility| Ages Eligible for Study: | 6 Months and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452907
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452907
Locations
| Mali | |
| Sanofi-Aventis Administrative Office | |
| Bougoula, Mali | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Valérie Lameyre | Sanofi |
More Information
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00452907 History of Changes |
| Other Study ID Numbers: |
ARTEN_L_00848 |
| Study First Received: | March 27, 2007 |
| Last Updated: | February 16, 2010 |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Artesunate Artemisinins Sulfadoxine Fanasil, pyrimethamine drug combination Pyrimethamine Lumefantrine Amebicides |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Antimalarials Anti-Infective Agents, Urinary Renal Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 24, 2017