Status:
COMPLETED
Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam
Lead Sponsor:
Oxford University Clinical Research Unit, Vietnam
Collaborating Sponsors:
Institute of Malaria, Parasitology and Entomology, Ho Chi Minh City, Viet Nam
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Conditions:
Plasmodium Vivax Malaria
Eligibility:
All Genders
3+ years
Phase:
PHASE4
Brief Summary
This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for treating vivax ma...
Eligibility Criteria
Inclusion
- Age \> 3 years;
- Mono-infection with P. vivax, parasitemia \> 250/µl asexual forms for in vivo and \>8000 asexual parasites/µl blood for in vitro testing;
- 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 malaria according to the definitions of WHO (2000);
- Mixed infection with P.falciparum and P.vivax of other plasmodium species;
- 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;
- Received 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;
- First trimester of pregnancy.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT01887821
Start Date
February 1 2013
End Date
June 1 2015
Last Update
September 30 2016
Active Locations (1)
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1
Bu Gia Map Health Station
Phước Hòa, Binh Phuoc, Vietnam