Status:
COMPLETED
Malaria Therapeutic Efficacy Study, Rwanda
Lead Sponsor:
Jhpiego
Collaborating Sponsors:
Ministry of Health, Rwanda
Centers for Disease Control and Prevention
Conditions:
Uncomplicated Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief Summary
WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emer...
Detailed Description
WHO recommends that Therapeutic Efficacy Studies (TES) for 1st and 2nd line antimalarial medicines should be routinely carried out and data made available for decision-making due to the threat of emer...
Eligibility Criteria
Inclusion
- Children aged 6 months to 59 months old
- Monoinfection with P. falciparum and parasitaemia of 1,000 - 100,000 asexual parasites per µl
- Axillary temperature 37.5 °C or history of fever in the preceding 24 hours before recruitment
- Ability to swallow oral medication
- Haemoglobin ≥7.0 g/dL at admission
- Informed consent from guardian/parent of patient
- Parent/guardian agrees to bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, and 42 (35 and 42 in DHA-PPQ arm only)
- Ability for the child to be admitted to a health center for inpatient blood testing, observation and treatment for three days
Exclusion
- Danger signs of severe malaria or signs of severe malaria
- Other underlying diseases (cardiac, renal, hepatic diseases)
- Severe malnutrition according to WHO child growth standards (WHO, 2006), children - with marasmus or oedematous malnutrition
- History of allergy to study drugs
- A clear history of receiving any antimalarial treatment in the preceding 72 hours
- Ongoing prophylaxis with drugs having antimalarial activity, such as cotrimoxazole for the prevention of Pneumocisti jirovici pneumonia in children born to HIV+ women
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT04767217
Start Date
June 14 2021
End Date
January 31 2024
Last Update
February 2 2024
Active Locations (3)
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1
Bugarama health center
Bugarama, Rwanda
2
Masaka health center
Masaka, Rwanda
3
Rukara health center
Rukara, Rwanda