Plasmodium Falciparum Malaria
Conditions
Keywords
Open randomized multi-centre clinical trial in Africa, Uncomplicated P. falciparum malaria, Artemisinin-based Combination Therapy, Artesunate + sulfalene + pyrimethamine, 24 hour treatment, Artemether + lumefantrine
Brief summary
The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.
Interventions
DRUGCo-Arinate FDC
DRUGCoartem
Sponsors
Dafra Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* age at least 6 months, * weight at least 5 kg, * residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda), * able to receive oral treatment, * having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours, * suffering from a mono specific P. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood.
Exclusion criteria
* presence of severe or complicated malaria (WHO 2000), * severe concomitant pathology or one that needs a medical follow-up incompatible with the study, * allergic to one of the drugs involved in this study, * pregnant (reported pregnancy, detected clinically or with the β HCG test), * use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR corrected Adequate Clinical and Parasitological Response | on day 28 (follow-up period) |
| Early treatment failure | between day 0 and day 3 |
| Late clinical failure | between day 4 and day 28 |
| Late parasitological failure | between day 7 and day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Safety - Adverse events | 28 day follow-up period |
| Parasitic clearance | 28 day follow-up period |
| Clinical and biological tolerance (Haemogram + Lever tests) | 28 day follow-up period |
| Haemoglobin levels | 28 day follow-up period |
| Fever clearance | 28 day follow-up period |
| Parasitological re-infection | 28 day follow-up period |
| Gametocyte carriage | 28 day follow-up period |
Countries
Cameroon, Mali, Rwanda, Sudan
Outcome results
None listed