Therapeutic efficacy of pyronaridine-artesunate for Plasmodium vivax in Myanmar

• Conditions: malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12618001621202
• Lead Sponsor: Ministry of Health and Sports

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-02
• Last Update Posted: 16 September 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

•patients aged 6 year and above
•mono-infection with P. vivax detected by microscopy (parasitaemia > 250/µl asexual forms);
•presence of axillary temperature greater than or equal to 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 from the patient or from a parent or guardian in the case of children aged less than age of majority;
•informed assent from any minor participant aged from 12 to age of majority years; and
•consent for pregnancy testing from female of child-bearing age(defined as age > 17 years and sexually active).

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;
•female aged from 12 and 17 years;
•Body weight under 20 kg;
•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; and
•unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age(defined as age > 12 years and sexually active).

Study & Design

• Study Type: Interventional
• Study Design: Not specified