Status:
WITHDRAWN
Artemisone for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Mahidol University
Medicines for Malaria Venture
Conditions:
Uncomplicated Falciparum Malaria
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
It has now been demonstrated clearly that in Western Cambodia parasitological responses to artesunate and artemether containing treatment regimens for uncomplicated falciparum malaria are slower than ...
Detailed Description
This is a small detailed randomised open-label clinical trial comparing the efficacy of oral artemisone with oral artesunate in the treatment of uncomplicated falciparum malaria in Western Cambodia. A...
Eligibility Criteria
Inclusion
- Age ≥ 16 years
- Full written informed consent is obtained
- Willingness and ability to comply with the study protocol for the duration of the trial including agreement to 5 days hospitalisation.
- History of fever or presence of fever (tympanic or axillary temperature at \>37.5 °C).
- Peripheral blood P.falciparum parasitaemia between 10,000/uL and 200,000/uL. (Mixed malaria infection included)
Exclusion
- Known hypersensitivity to the study drugs.
- Any antimalarial drug treatment in the 48 hours prior to enrolment.
- Clinical and/or laboratory features of severe malaria (as defined by WHO).
- Gastrointestinal dysfunction that could alter absorption or motility (i.e. active peptic ulcer, inflammatory bowel disease, malabsorption syndromes, intestinal sub-occlusion or previous major gastrointestinal surgery).
- Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
- Splenectomy.
- Pregnant or lactating women. Serum test for β-HCG to be performed on any woman of child bearing age unless menstruating.
- Taking any contraindicated medicines (as listed in the most up to date product information)
- Participation in a clinical study within the previous 12 weeks
- Any other condition in the opinion of the investigator makes the patient unsuitable to be a subject
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00936767
Start Date
October 1 2010
End Date
October 1 2010
Last Update
August 31 2018
Active Locations (1)
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1
Pailin Hospital
Pailin, Cambodia