Routine Monitoring and Evaluation of efficacy and safety of Dihydroartemisinin-Piperaquine in Kvav Health Centre (Siemreap), in Kbal Romeas ( Stung Treng), in Veurn Sai (Rattanakiri) and in Koh Ngek Health Centre (Mondulkiri) for the treatment of uncomplicated Plasmodium falciparum malaria in Cambodia 2014.

Completed

• Conditions: ncomplicated Plasmodium falciparum Malaria; Uncomplicated Plasmodium falciparum Malaria; Infection - Other infectious diseases

• Registration Number: ACTRN12615000696594
• Lead Sponsor: Ministry of Health, Cambodia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

*age between 2 and 60 years except unmarried females between 12 and 18 years old (potential unpredicted pregnancy);
mono-infection with P. falciparum by microscopy; P. falciparum parasitaemia of 500-100,000/microliter asexual forms;
*presence of axillary above to 37.5 °C or history of fever during the past 24 h;
*ability to swallow oral [by mouth] 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 aged less than 12 years;
*informed assent from any minor participant aged more than 12 years and less than 60 years; and
*consent for pregnancy testing from female of child-bearing potential and from their parent or guardian if under 18 years.

Exclusion Criteria

*presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
*weight under 5 kg;
*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 < 110 mm);
*presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea 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);
*unmarried women 12-18 years old;
*a positive pregnancy test or breastfeeding;
*unable to or unwilling to take a pregnancy test or unwilling to take pregnancy test or contraceptives (for women of child-bearing age).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with treatment failures. Patients will be classified as early late clinical failure, late parasitological failure or an adequate clinical and parasitological response. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis.[days 1, 2, 3, 7, 14, 21, 28, 35 and 42.]

Secondary Outcome Measures

Name	Time	Method
The frequency and nature of adverse events. Clinical examination to detect blistering, peeling, loosening of skin, chills, convulsions, difficulty swallowing, fast heartbeat, joint or muscle pain etc...<br> [days 1, 2, 3, 7, 14, 21, 28, 35 and 42.]