Efficacy and safety of dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in 6 sentinel sites in Indonesia
- Conditions
- MalariaInfection - Studies of infection and infectious agents
- Registration Number
- ACTRN12614000753651
- Lead Sponsor
- Ministry of Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 1200
*age between one year (weight more than 5 kgs) to 65 years old;
*mono-infection with P. falciparum or P. vivax detected by microscopy;
*parasitaemia of more than 1000/µl asexual parasites
*presence of axillary temperature equal to or greater than 37.5 degrees Centigrade 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.
*presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1); presence of danger signs as described in appendix 1 in patients with P. vivax infections
*Unmarried females over 12 years of age or who have had their menarche
*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 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 in eligible married women (include this criterion only if adults are included)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % of dihydroartemisinin-piperaquine treatment failures (early treatment failure+late clinical failure+late parasitological failure). Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 42 days follow-up and treatment outcomes will be classified according to the latest WHO protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).[At 42 day following treatment];% of adverse events (abdominal discomfort, nausea, headache and dizziness and any other events) in the dihydroartemisinin-piperaquine treated patients. All patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. All adverse events will be recorded on the adverse event form[At 42 day following treatment]
- Secondary Outcome Measures
Name Time Method To determine the blood concentration of piperaquine to assess treatment adherence and the relationships of drug level at these times and treatment failure[On day 7 and day of recurrence]