Status:
UNKNOWN
Effectiveness of Artemisinin Combination Regimens in Falciparum Malaria
Lead Sponsor:
Medecins Sans Frontieres, Netherlands
Collaborating Sponsors:
Mahidol University
University of Oxford
Conditions:
Uncomplicated Falciparum Malaria
Eligibility:
All Genders
6+ years
Phase:
PHASE4
Brief Summary
Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the ...
Detailed Description
Malaria in Myanmar: In Myanmar, malaria is the number one cause of morbidity. According to the Department of Health (DoH) and WHO there are approximately 500,000 patients with malaria each year. Abou...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age over 6 months and
- Weight ≥ 5 kg, and
- Slide-confirmed infection with Plasmodium falciparum (including mixed infections), and
- Asexual parasite density between 500 and 200,000/µl of blood, and
- Informed consent from a parent or guardian aged at least 18 years.
- Exclusion criteria
- General danger signs according to the WHO definition or
- Signs of severe/complicated malaria according to the WHO definition or
- Severe anaemia (haemoglobin \< 5 g/dL), or
- Known history of hypersensitivity to any of the study drugs, or
- Severe malnutrition (as defined by a weight-for-height below 70% of median and/or symmetrical oedemas involving at least the feet), or
- Concomitant febrile illness due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration, etc.; mild flu should not lead to exclusion) or
- History of psychiatric diseases, or
- Having received a full course treatment including MQ in the preceding 9 weeks or
- Having received any other antimalarials in the previous 48 hours.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00902811
Start Date
December 1 2008
End Date
December 1 2009
Last Update
May 15 2009
Active Locations (4)
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1
Dabhine and Mingan Clinic
Sittwe, Rakhine State, Burma
2
Myit Kyi Nar Clinic
Kachin, Burma
3
Myothugyi Rural Health Center, Bu Thee Daung
Maungdaw, Burma
4
Lashio Clinic
Shan, Burma