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Efficacy of artesunate 7days therapy for the treatment of uncomplicated Plasmodium falciparum malaria in Pa-an (Mon State) in Myanmar.

Phase 3
Recruiting
Conditions
Malaria
Infection - Other infectious diseases
Registration Number
ACTRN12614000215628
Lead Sponsor
Clinical Research Unit ( Malaria), Defense Services General Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

male and female age older than 18 years; mono-infection with P. falciparum detected by microscopy (parasitaemia of 10 000-100 000/microlitres asexual forms or P. vivax detected by microscopy (parasitaemia greater than 250/microlitres asexual forms); presence of axillary greater than or equal to 37.5 degrees celcius 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; and informed consent from the patient

Exclusion Criteria

Presence of signs of severe falciparum malaria according to the definitions of WHO; mixed or mono-infection with another Plasmodium species detected by microscopy; presence of febrile conditions due to diseases other than malaria (e.g. 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; history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and a positive pregnancy test or breastfeeding unable to or unwilling to take a pregnancy test or contraceptives (for women of child-bearing age);patients presenting with splenectomy.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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