Efficacy and safety of Dihydroartemisinine-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for Plasmodium vivax in Homalin (Sagaing Division), Lashio (Shan State) and Bokepyin (Tanintharyi Division).

Phase 3

Recruiting

• Conditions: Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12614000214639
• Lead Sponsor: Clinical Research Unit (malaria), Defense Services General Hospital

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: 200

Inclusion Criteria

age above 13 years inclusive and above except females aged 13-17 year old inclusive;
- mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/micro litre asexual forms) or P. vivax detected by microscopy (parasitaemia greater than 250/micro litre asexual forms);
- presence of axillary equal to 37.5 degrees celsius 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 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); and
- a positive pregnancy test or breastfeeding;
- unable to or unwilling to take a pregnancy test or contraceptives.

Study & Design

• Study Type: Interventional
• Study Design: Not specified