Malaria
Conditions
Brief summary
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
Interventions
DRUGCoarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)
Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg
DRUGCoartem® (arthemether+ lumefantrine)
Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range. Duration of treatment: 3 days
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR corrected and uncorrected clinical and parasitological cure rate | at D28 and for the first attack |
Secondary
| Measure | Time frame |
|---|---|
| Fever and parasitological clearance | first attack |
| Proportion of afebrile patients and proportion of patients without parasites | at D3 for the following attacks |
| Clinical tolerability (incidence and intensity of recorded AE) | during the study period |
| PCR corrected and uncorrected clinical and parasitological cure rate | at D28 and for the next attacks |
| Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years) | at the time of the first attack |
| Assessment and evolution of hearing function in patients groupe aged >=12 years | during the study period |
| Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) | during the study period |
Countries
Senegal
Outcome results
None listed