Status:
COMPLETED
Single Low-dose Primaquine Efficacy and Safety.
Lead Sponsor:
Tropical Pesticides Research Institute, Tanzania
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions:
Malaria
Eligibility:
All Genders
1-10 years
Phase:
PHASE4
Brief Summary
Background: The World Health Organization has recommended addition of a 0.25 mg/kg single-dose primaquine (PQ) to standard artemisinin-based combination therapy (ACT) for elimination of malaria in low...
Eligibility Criteria
Inclusion
- Age from 1 to 10 years
- Weight ≥ 10 kg
- Body temperature ≥ 37.5°C or history of fever in the last 24 hours
- Microscopy confirmed P. falciparum mono-infection
- Parasitemia level of 2000 - 200000/µL
- Ability to swallow oral medication
- Ability and willingness to abide by the study protocol and the stipulated follow up visits
- Written proxy informed consent from a parent/guardian.
Exclusion
- Evidence of severe malaria or danger signs
- Known allergy to trial medicines
- Reported antimalarial intake ≤ 2 weeks
- Hemoglobin \< 5 g/dL
- Blood transfusion within last 90 days
- Febrile condition other than malaria
- Known underlying chronic or severe disease
Key Trial Info
Start Date :
June 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT03352843
Start Date
June 11 2019
End Date
February 28 2020
Last Update
February 24 2023
Active Locations (1)
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1
Tropical Pesticides Research Institute (TPRI)
Arusha, Tanzania