Status:
COMPLETED
Malaria Therapeutic Efficacy Study (TES) Kenya
Lead Sponsor:
Jhpiego
Collaborating Sponsors:
Kenya Ministry of Health
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
- age between 6 months to 59 months; mono-infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection);
- parasitaemia of 1,000 - 100,000/µl asexual forms;
- presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24 h;
- ability to swallow oral medication;
- haemoglobin ≥5.0 g/dL at admission;
- informed consent from a parent or guardian;
- parent/guardian agrees to bring the patient for planned follow-up visits at day 7, 14, 21, and 28
Exclusion
- general danger signs or signs of severe falciparum malaria according to the definitions of WHO;
- severe malnutrition according to WHO child growth standards (WHO, 2006), children with marasmus or oedematous malnutrition;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- 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);
- history of receiving any antimalarial treatment in the preceding 72 hours;. exposure to malaria vaccine
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2022
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04767191
Start Date
March 15 2021
End Date
December 18 2022
Last Update
November 1 2023
Active Locations (2)
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1
Makhonge Health Centre
Bungoma, Bungoma County, Kenya
2
Kaluo Health Centre
Siaya, Siaya County, Kenya