Efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in 2 sentinel sites in Indonesia

Phase 4

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

• Registration Number: ACTRN12616001533482
• Lead Sponsor: Ministry of Health of Indonesia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

1.age between one year to 65 years old, excluding female minors aged 12 to 17 years;
2.mono-infection with P. falciparum or P. vivax detected by microscopy;
3.parasitaemia of more than 500 asexual parasites per microliter for P. falciparum and 250 asexual parasites per microliter P.vivax
4.presence of axillary temperature greater or equal to 37.5 degrees C or history of fever during the past 24 h;
5.ability to swallow oral medication;
6.ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
7.informed assent from any minor participant aged from 12 to 17 years (age of majority in the country); and
8.consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under the age of majority years.

Exclusion Criteria

1.presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
2.weight under 5 kg;
3.mixed or mono-infection with another Plasmodium species detected by microscopy;
4.presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference below 115 mm);
5.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);
6.regular medication, which may interfere with antimalarial pharmacokinetics;
7.history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and
8.a positive pregnancy test or breastfeeding (include this criterion only if adults are included)
9.unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent of treatment failures (early treatment failure + late clinical failure +late parasitological failure). This is composite primary outcome.<br>Enrolled patients will be assessed for parasitological and clinical responses during the 42 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.<br>[At days 1, 2, 3, 7, 14, 21 and 28, 35 and 42 following treatment.]