Malaria
Conditions
Brief summary
Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient. Secondary objectives: For the first attack: To compare the 2 groups of treatment in terms of: * Day 42 efficacy * Parasitological and fever clearance * Clinical and Biological tolerability * Evolution of gametocyte carriage For attack 2nd and following: To compare the 2 groups of treatment in terms of: * Day 28 and Day 42 clinical and parasitological effectiveness * Clinical and Biological tolerability * Proportion of patients without fever at Day 3 * Proportion of patients without parasites at Day 3 * Evolution of gametocyte carriage * Compliance During the total follow up of the cohort: To compare the 2 groups of treatment in terms of: * Treatment incidence density * Impact of repeated treatment on clinical and biological tolerability * Impact on anaemia * Impact on Hackett score.
Interventions
DRUGCoartem
Oral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days
DRUGCoarsucam
Oral route, once 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
Age
6 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
Specific inclusion criteria for initial enrollment: * Confirmed mono infection with Plasmodium falciparum, with parasite density ≥2000 asexual forms per µl of blood, Inclusion criteria for each attacks: * Body weight ≥5 kg * Able to be treated by oral route * Fever (axillary temperatur ≥37.5 degrees Celsius) at D0 or history of fever within the previous 24 hours * Confirmed Plasmodium falciparum infection with positive paratesimia * Haemoglobin value ≥5.0 g/dl
Exclusion criteria
Specific
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR corrected and uncorrected clinical and parasitological cure rate | At Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of afebrile patients and proportion of patients without parasites | At Day 3 (following attacks) |
| Evolution of baseline symptoms (Clinical efficacy measure) | During the study conduct |
| Number of residual tablets in blisters (compliance) | At the end of the study treatment |
| Treatment incidence density: comparison of the number of malaria attacks between the 2 arms | During the 2 years of follow-up |
| Fever and parasitological clearance evaluation by measuring the axillary temperature and monitoring paratesimia | At the first attack |
| Incidence and intensity of recorded AE | from the informed consent signed up to the end of the study |
| Biological tolerability (Hb, Bilirubin, ALAT, Creatinine, Leucocytes, Neutrophils and Platelets count) | During the study conduct |
| PCR corrected and uncorrected clinical and parasitological cure rate | At Day 42 |
| Mean delay between 2 attacks | during the 2 years of follow-up |
Countries
Uganda
Outcome results
None listed