Status:
UNKNOWN
Evaluation of Three Artemisinin-based Combinations for the Treatment of Uncomplicated Malaria in Childreen in Burkina Faso (CHIMIO2)
Lead Sponsor:
Centre national de recherche et de formation sur le paludisme
Collaborating Sponsors:
Programme national de lutte contre le paludisme (PNLP), Burkina Faso
Unité de recherche clinique de Nanoro (URCN)
Conditions:
Malaria
Burkina Faso
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
Bakground In Burkina Faso, since the adoption of this new malaria treatment policy in 2005, several studies evaluating the efficacy and tolerance of ACTs have been carried out by different research te...
Eligibility Criteria
Inclusion
- Children of both sexes aged 6 months to 12 years inclusive;
- Microscopic confirmation of a monospecific infection by P. falciparum (Parasitaemia between 2000 - 200,000 / μl);
- Fever (uncorrected axillary or tympanic temperature ≥37.5 ° C or history of fever reported within the last 24 hours
- Hemoglobin level ≥ 5.0 g / dl
- Ability to take oral medication;
- Ability and willingness of parents to respect the protocol for the duration of the study and to respect the consultation schedule;
- Signature (or fingerprint (thumb) when parents / guardians are illiterate) of the consent form by the child's parents or guardians.
Exclusion
- General danger signs in children under five (inability to drink or breastfeed, repeated vomiting (\> 2 times in 24 hours), convulsions, unconsciousness, inability to sit or stand standing)
- Body weight less than 5 kg;
- Fever due to illnesses other than malaria (e.g. measles, acute lower respiratory infection, severe diarrheal illness with dehydration) or presence of other known chronic or serious underlying illnesses or any other condition (e.g. illness cardiac, renal or hepatic, HIV / AIDS) which in the judgment of the clinical investigator would place the subject at potential risk or interfere with the conduct of the study;
- Previous complete antimalarial treatment with an ACT within the last two weeks;
- History of hypersensitivity to any of the drugs tested
- Severe malnutrition (defined by a z score of weight for age less than -3 or other severe malnutrition sign).
- Known individual or family history of clinical disorders of prolongation of QT intervals or sudden death
- Previous participation in a malaria vaccine clinical trial
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT04778813
Start Date
June 1 2021
End Date
June 1 2022
Last Update
March 3 2021
Active Locations (1)
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1
Centre national de recherche et de formation sur le paludisme (CNRFP)
Ouagadougou, Kadiogo, Burkina Faso, 2208