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OpenTrials
Completed

NCT Number: NCT00452907

ACT MALI: Treatment of Malaria Based on Combination Therapies

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

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Bougoula, Mali

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artesunate

Drug

oad, per os, 3 days of treatment

Artesunate + Sulfadoxine-Pyrimethamine

Drug

oad, per os

arthemether + lumefantrine

Drug

bid, per os. Duration of treatment: 3 days

Primary outcomes

  1. Clinical and parasitological cure rate

    Time frame: at day 28

  2. Clinical and biological tolerability

    Time frame: During the study period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Mar 28, 2007
Registry last updated
Feb 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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