ACT MALI: Treatment of Malaria Based on Combination Therapies

NCT ID: NCT00452907

Last Updated: 2010-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

780 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Arsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment

Group Type EXPERIMENTAL

Artesunate

Intervention Type DRUG

oad, per os, 3 days of treatment

2

Arsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os

Group Type ACTIVE_COMPARATOR

Artesunate + Sulfadoxine-Pyrimethamine

Intervention Type DRUG

oad, per os

3

Coartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days

Group Type ACTIVE_COMPARATOR

arthemether + lumefantrine

Intervention Type DRUG

bid, per os. Duration of treatment: 3 days

Interventions

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Artesunate

oad, per os, 3 days of treatment

Intervention Type DRUG

Artesunate + Sulfadoxine-Pyrimethamine

oad, per os

Intervention Type DRUG

arthemether + lumefantrine

bid, per os. Duration of treatment: 3 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Valérie Lameyre

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Bougoula, , Mali

Site Status

Countries

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Mali

Other Identifiers

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ARTEN_L_00848

Identifier Type: -

Identifier Source: org_study_id

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