Monitoring the Efficacy of Artesunate+Sulfadoxine-Pyrimethamine and Artemether Plus Lumefantrine in Uncomplicated Falciparum Malaria in Pakistan

Bannu Medical College0 个研究点目标入组 240 人开始时间: 2012年10月12日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Age greater than 6 months, excluding 12-17 old female minors and unmarried females aged 18 years and above;
•2. mono-infection with P. falciparum detected by microscopy;
•3. Parasitaemia of 1000 – 250000 / microlitre asexual forms for sites in Sindh, Balochistan and Khyber Pakhtoonkwa.
•4. Presence of axillary temperature equal to or greater than 37.5 degrees celsius or history of fever during the past 48 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 consent from the patient or from a parent or guardian in the case of children.

•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. Mixed or mono-infection with another Plasmodium species detected by microscopy;
•3. 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 less than 110 mm);
•4. 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);
•5. Regular medication, which may interfere with antimalarial pharmacokinetics;
•6. History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and
•7. 12-17 old female minors and unmarried females aged 18 years and above;

发起方

Bannu Medical College