Status:
COMPLETED
Study of Malaria Treatment at Phuoc Long Hospital, Binh Phuoc Province, Vietnam
Lead Sponsor:
Oxford University Clinical Research Unit, Vietnam
Collaborating Sponsors:
World Health Organization
Conditions:
Malaria
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
Background: There are worrying signs from Western Cambodia that parasitological responses to artesunate containing treatment regimens for uncomplicated falciparum malaria are slower than elsewhere in ...
Detailed Description
This surveillance study is a three-arm prospective evaluation of the efficacy of artesunate and dihydroartemisinin-piperaquine in acute uncomplicated falciparum malaria. This will be an evaluation of ...
Eligibility Criteria
Inclusion
- male and aged \> 10 years OR;
- female patients \> 10 and \<12 years old, provided they have not reached menarche
- mono-infection with P. falciparum detected by microscopy;
- parasitaemia of 10,000 - 100,000/µl asexual forms;
- presence of axillary or tympanic 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;
- informed consent/assent.
Exclusion
- presence of general danger signs or severe falciparum malaria according to the definitions of WHO;
- mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference \< 110 mm);
- 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;
- treatment with antimalarial drugs in the previous 48 hours;
- history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
- splenectomy.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT01165372
Start Date
August 1 2010
End Date
May 1 2011
Last Update
September 15 2011
Active Locations (1)
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1
Phuoc Long Hospital
Dong Xoai, Binh Phuoc, Vietnam, 84