Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

Sanofi

Status and phase

Completed

Phase 4

Conditions

Malaria

Treatments

Drug: Coartem® (arthemether+ lumefantrine)

Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00540410

ARAMF_L_02873

Details and patient eligibility

About

Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject.

Secondary objectives:

For the first attack: To compare the two groups of treatment in terms of:

D14 efficacy
Parasitological and fever clearance
Clinical and biological tolerability
Evolution of gametocyte carriage
Cardiac tolerability (QTc)

For the repeated attacks: To compare the two groups of treatment in terms of:

D14 and D28 clinical and parasitological effectiveness (PCR adjusted)
Clinical and biological tolerability
Proportion of patients without fever at D3
Proportion of patients without parasite at D3
Compliance
Impact on anaemia

During the total follow-up of the cohort: To compare the two groups of treatment in term of:

Treatment incidence density
Impact of repeated treatment on clinical and biological safety
Impact of repeated treatment on hearing capacity

Enrollment

366 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Lists of Inclusion and Exclusion criteria:

Inclusion Criteria:

adults or children weighting more than 5 kg
axillary temperature >=37.5°C at D0 or history of fever within the previous 24hrs
confirmed Plasmodium falciparum monoinfection, with parasitemia>1000mcl
negative urinary pregnancy test for women of child bearing age before each new administration of treatment

Exclusion Criteria:

presence of any serious or clinical danger sign of malaria: prostration, consciousness disorders, recent and repeated convulsions, respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic BP< 70 mmHg in adults or < 50 mmHg in children, spontaneous bleeding, inability to sit or stand
severe concomitant disease
allergy to one of the investigational drugs.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.