Efficacy and safety of dihydroartemisinin+piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Bosaso, Puntland, Somalia.

Ministry of Health of Puntland0 sites88 target enrollmentStarted: April 29, 2016Last updated: January 13, 2020

Conditions

Trial Snapshot

No summary available.

•1. age between six months and 60 years with the exception of 12-17 years old female minors and unmarried females 18 years and above;
•2. mono-infection with P. falciparum detected by microscopy;
•3. parasitaemia of 500–200,000/microliter asexual forms;
•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;
•7. informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years.
•8. informed assent from any minor participant aged from 12 to 18 years; and
•9.. consent for pregnancy testing from married female of 18 years and above.

•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 diarrhea 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);
•8. a positive pregnancy test or breastfeeding of married women aged 18 years and above; and
•9. unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active.

Sponsor

Ministry of Health of Puntland