Efficacy and safety of artesunate tablet and drug combination (dihydroartemisinin – piperaquine) for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for vivax malaria in 5 sentinel sites (Binh Phuoc, Dak Nong, Gia Lai, Ninh Thuan and Quang Tri provinces), Viet Nam in 2008 and 2009

Phase 4

Completed

• Conditions: Malaria; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12611000181909
• Lead Sponsor: Ministry of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Adults and children over 6 months old;
- single Infection with P. falciparum;
- Parasitaemia: 1 000–200 000 asexual forms per micro ml of blood;
- Presence of axillary temperature greater than or eqqual 37.5 degrees Centigrade or history of fever within the previous 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 case of children.

Exclusion Criteria

- Presence of general danger signs among children <5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions.
- Mixed or mono-infection with another Plasmodium species;
- Presence of severe malnutrition
- Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS);
- History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment;
- Positive pregnancy test or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day cure rate or ACPR (adequate clinical and parasitological response) (absence of Parasitemia on day 28, irrespective of axillary temparature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure of late parasitological failure).[after start of the study: Day 1, Day 2, Day 3, Day 7, Day 14, Day 21 and D28.]

Secondary Outcome Measures

Name	Time	Method
PCR-corrected ACPR (PCR: polymerase chain reaction, a molecular tool/test to differentiate if the failure is a true resistance or reinfection)[after start of the study (Day 7, Day 14, Day 21 and Day 28)]