ACT MALI: Treatment of Malaria Based on Combination Therapies

Sanofi

Status and phase: Completed; Phase 4

Conditions: Malaria

Treatments: Drug: Artesunate + Sulfadoxine-Pyrimethamine; Drug: Artesunate; Drug: arthemether + lumefantrine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00452907

ARTEN_L_00848

Details and patient eligibility

About

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

Enrollment: 780 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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780 participants in 3 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Artesunate

2

Active Comparator group

Description:

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

Treatment:

Drug: Artesunate + Sulfadoxine-Pyrimethamine

3

Active Comparator group

Description:

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

Treatment:

Drug: arthemether + lumefantrine