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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.
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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 Lumefantrine Pyrimethamine Artesunate Artemisinins Sulfadoxine Fanasil, pyrimethamine drug combination Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Amebicides Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on June 23, 2017