Routine Monitoring and Evaluation of efficacy and safety of dihydroartemisinin-piperaquine in Tasagn Health Centre (Battam Bang Province), in Promaoy Health Centre ( Pursat province), in Oral Health Centre (Kampong Speu province), and in Sandan health centre (Kampong Thom province) for the treatment of uncompleted Plasmodium falciparum malaria in Cambodia.

Ministry of Health of Cambodia0 个研究点目标入组 240 人开始时间: 2015年7月30日最近更新: 2020年1月13日

试验速览

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•age between 2 and 60 years except unmarried females between 12 and 18 years old (potential unpredicted pregnancy);
•- mono-infection with P. falciparum detected by microscopy; P. falciparum parasitaemia of 500-200,000/microliter asexual forms;
•- 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
•- Patients were evaluated clinically and parasitologically based on the specific inclusion criteria: over two years of age; fever (above 37.5 degrees Celsius) or history of fever in the last two days; P. falciparum mono-infection with parasite density between 500 to 200,000 asexual parasites/microliter and the exclusion criteria of the study;
•- If a patient is eligible for the study the researcher asks if the patient can involve in the study by explaining all the process, procedure and all potential risks of drug side effects.
•- If the patient agrees to participate in the study then the patient needs to sign in an inform consent.
•- The patients are to stay at the health facilities for 3 or 4 days until the parasites completely clear from their bodies
•- The patient has to come back to the study site for follow up on weekly basis over 42 days.
•- During the follow up the patient receives the physical and parasitological examination (i.e, blood slide).

•*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).

发起方

Ministry of Health of Cambodia