Status:
UNKNOWN
Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya
Lead Sponsor:
Sabah Ahmed Omar
Collaborating Sponsors:
World Bank
Kenya Medical Research Institute
Conditions:
Malaria
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
Brief Summary
Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of Malaria Control (DOMC...
Eligibility Criteria
Inclusion
- Age between 6 months - 5 years (in high endemic areas); 6 months to 10 years (in low endemic areas) inclusive.
- Presence of axillary temperature \> 37.5oC or rectal / tympanic temp \> 38.0oC, or history of fever in the last 24 hours.
- Monoinfection with Plasmodium falciparum with parasitaemia, asexual parasitemia between 2,000 - 200,000 p/µl (in areas of high transmission); 1,000-100,000p/ µl (in areas of low to moderate malaria transmission)
- Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
- Signed informed consent form by the parents or legal 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 co-morbid infection (e.g. acute lower respiratory tract infection, severe diarrhoea with dehydration, Severe Anaemia) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases,Epilepsy, HIV/AIDS);
- 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 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
2100 Patients enrolled
Trial Details
Trial ID
NCT01899820
Start Date
April 1 2013
End Date
July 1 2015
Last Update
October 8 2013
Active Locations (7)
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1
Busia district hospitals
Busia, Busia County, Kenya
2
Kisii district hospitals
Kisii, Kisii County, Kenya
3
Kitale district hospitals
Kitale, Kitale, Kenya
4
Msambweni sub-district hospital
Msambweni, Kwale County, Kenya