Status:
UNKNOWN
Have Malaria Infections in Kenya Become Less Responsive to Artemisinin Treatment?
Lead Sponsor:
KEMRI-Wellcome Trust Collaborative Research Program
Collaborating Sponsors:
University of Oxford
Heidelberg University
Conditions:
Malaria
Eligibility:
All Genders
6-10 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether P. falciparum infections in Kilifi District have developed tolerance to the artemisinin class of drugs.
Detailed Description
Artemisinin-based combination therapies (ACT) are the treatment of choice for episodes of uncomplicated P. falciparum malaria in all endemic countries. Rapid clearance of pathogenic blood stage malari...
Eligibility Criteria
Inclusion
- aged between 6 months to 10 years, inclusive
- mono-infection with P. falciparum detected by microscopy;
- parasitaemia of 10,000-300,000/µl asexual forms;
- presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24 h;
- ability to swallow oral medication;
- ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
- informed consent from a parent or guardian.
Exclusion
- presence of clinical danger signs: not able to drink or breast-feed, vomiting (\>twice in 24 hours), recent history of convulsions (\>1 in 24h), unconscious state, unable to sit or stand;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe acute malnutrition defined as weight for height \<70% of the median NCHS/WHO (Appendix 2);
- presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea 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 or pharmacodynamic assessments (e.g., antibiotics with known antimalarial activity); and
- history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT01190371
Start Date
April 1 2011
End Date
December 1 2018
Last Update
February 23 2018
Active Locations (3)
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1
Kadzinuni Dispensary
Kadzinuni, Kilifi County, Kenya
2
Junju Dispensary
Kilifi, Kenya
3
Pingilikani Dispensary
Kilifi, Kenya