Malaria
Conditions
Interventions
Evaluation de l efficacite et de l innocute des antipaludiques
There is no control group in a phse IV
Sponsors
Ministere de la Sante Publique
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 6 and 120 months (6 months and 10 years). Mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection). Parasitemia of 1000 - 200.000 parasites/µl. Presence of axillary temperature = 37.5 °C or history of fever during the past 24 h Ability to swallow oral medication. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule. Informed consent from the patient or from a parent or guardian in the case of children aged less than age of majority.
Exclusion criteria
Exclusion criteria: Pesence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO. Mixed or mono-infection with another Plasmodium species detected by microscopy. Presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below –3 z-score, or has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 115 mm). Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS). Regular medication, which may interfere with antimalarial pharmacokinetics. History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early treatment failure •danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia; •parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature; •parasitaemia on day 3 with axillary temperature = 37.5 ºC; •parasitaemia on day 3 = 25% of count on day 0. Late treatment failure Late clinical failure •danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 in patients who did not previously meet any of the criteria of early treatment failure; •presence of parasitaemia on any day between day 4 and day 28 with axillary temperature = 37.5 ºC or history of fever in patients who did not previously meet any of the criteria of early treatment failure. Late parasitological failure •presence of parasitaemia on any day between day 7 and day 28 with axillary temperature < 37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure. Adequate clinical and parasitological response •absence of parasitaemia on day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the polymorphism of molecular markers for antimalarial drug(s) resistance; K13, pfmdr1, dhfr et dhps. | — |
Countries
Burundi
Contacts
Public ContactBaza Bismas
Medical officer
Outcome results
None listed