ACT MALI: Treatment of Malaria Based on Combination Therapies - Full Text View

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 Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine Lumefantrine

Genetic and Rare Diseases Information Center resources: Malaria

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Clinical and parasitological cure rate [ Time Frame: at day 28 ] [ Designated as safety issue: No ]
Clinical and biological tolerability [ Time Frame: During the study period ] [ Designated as safety issue: No ]


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
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations


Mali
Sanofi-Aventis Administrative Office
Bougoula, Mali

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	Valérie Lameyre	Sanofi

More Information

No publications provided


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
Health Authority:	Mali: University of Bamako

Additional relevant MeSH terms:


Malaria Parasitic Diseases Protozoan Infections Artesunate Fanasil, pyrimethamine drug combination Lumefantrine Pyrimethamine Sulfadoxine Amebicides Anti-Infective Agents	Anti-Infective Agents, Urinary Antimalarials Antiparasitic Agents Antiprotozoal Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Renal Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015