None listed
Conditions
Brief summary
This surveillance study is a one-arm prospective evaluation of the clinical and parasitological responses to directly observed treatment for uncomplicated malaria. The objective is to assess the efficacy and safety of dihydroartemisinin-piperaquine (DHA-PIP) and artesunate (AS7) monotherapy for the treatment of uncomplicated Plasmodium falciparum malaria in 2 sites Dehong and Menglian, Pu’er, Yunnan province in China. The WHO 28-day in vivo protocol will be used. People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with the ACT DHA-PIP or 7-day artesunate monotherapy and monitored weekly for 28 days. The follow-up consists of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. On the basis of the results of these assessments, the patients will be classified as having therapeutic failure (early or late) or an adequate response. The proportion of patients experiencing therapeutic failure during the follow-up period will be used to estimate the efficacy of the study drug. PCR analysis will be used to distinguish between a true recrudescence or reinfection. The results of this study will be used to assist the Ministry of Health of China in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria.
Interventions
The efficacy and safety of 2 drugs used by the control program as anti-malarial standard treatment, artesunate and DHA-PIP, will be assessed separately in 2 different groups of patients in 2 different study sites. Malaria patients in Yingjiang, Dehong site will receive co-formulated DHA-PIP for 3 days. Patients in Menglian site will receive Artesunate for 7 days.
All drugs will be given by oral route.
Artesunate will be administered at a total dose of 16 mg/kgbw over 7 days (1st day: 4 mg/kgbw,
The efficacy and safety of 2 drugs used by the control program as anti-malarial standard treatment, artesunate and DHA-PIP, will be assessed separately in 2 different groups of patients in 2 different study sites. Malaria patients in Yingjiang, Dehong site will receive co-formulated DHA-PIP for 3 days. Patients in Menglian site will receive Artesunate for 7 days. All drugs will be given by oral route. Artesunate will be administered at a total dose of 16 mg/kgbw over 7 days (1st day: 4 mg/kgbw, 2nd to 7th days: 2 mg/kgbw/day). Dydroartimisinin- piperquine(DHA-PIP) dose is a dose of 2mg/kg/day DHA and 16mg/kg/day PIP for 3 days. The “WHO 28 day in vivo” protocol, used in this study, consists of parasite count and temperature measurements at baseline (day0 before dosing) and on days 1, 2, 3, 7, 14, 21 and 28.
Sponsors
National Institute of Parasitic Diseases, China Center for Disease Control and Prevention
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 60 Years
Healthy volunteers
No
Inclusion criteria
- age between 6 months to 60 years old; - mono-infection with P. falciparum detected by microscopy with parasitaemia of 1000-100,000/ul asexual forms - presence of axillary or tympanic temperature = 37.5 degrees centigrade, or oral or rectal temperature of = 38 degrees centigrade or history of fever during the past 24 hours; - 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.
Exclusion criteria
- 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 that 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; - unable to or unwilling to take a pregnancy test or contraceptives (for women of child-bearing age). - Unmarried women 12-18 years old.
Outcome results
None listed