Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for Plasmodium vivax in Ta Beik Kyin Township, Mandalay Region and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria in Ta-mu township, Sagaing Regio

Phase 3

Recruiting

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12614000216617
• Lead Sponsor: Department of Medical Research (Upper Myanmar)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Criteria are. ge between 6 years inclusive and above; mono-infection with plasmodium falciparum detected by microscopy (parasitaemia of 500-100,000/microlitre asexual forms) or plasmodium vivax detected by microscopy (parasitaemia great than 250/microlitre asexual forms); presence of axillary equal to or great than 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 or from a parent or guardian in the case of children.

Exclusion Criteria

presence signs of 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 less than 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; history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); a positive pregnancy test or breastfeeding for falciparum malaria; and unable to or unwilling to take a pregnancy test or contraceptives.

Study & Design

• Study Type: Interventional
• Study Design: Not specified