Efficacy and safety of artesunate+mefloquine+primaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Tak, Ratchaburi, Ranong and Yala provinces in Thailand

Bureau of Vector-borne Disease0 sites300 target enrollmentStarted: July 9, 2010Last updated: January 13, 2020

Conditions

Trial Snapshot

No summary available.

•Age 6 months and above;
•-Mono-infection with Plasmodium falciparum detected by microscopy
•-P. falciparum parasitaemia of 500-1000000/ul asexual forms
•-presence of axillary or tympanic temperature equal or more than 37.5C 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
•-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 or other known underlying chronic or severe diseases
•-Regular medication, which may interfere with antimalarial pharmacokinetics
•-history of hypersensitivity reactions or contraindications to any of the medicine being tested or used as alternative treatment
•-Female of child-bearing potential with ages 12-17 years old inclusive
•-A positive pregnancy test or breastfeeding
•-Unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age

Sponsor

Bureau of Vector-borne Disease