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 and chloroquine (CQ) for the treatment of Plasmodium vivax malaria in 4 sites in Vietnam. The drugs and study sites are: AS7 in Bu Dang of Binh Phuoc and Tuy Duc of Dak Nong, DHA-PIP in Gia Lai, and DHA-PIP and CQ in Huong Hoa of Quang Tri, Viet Nam. 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 or chloroquine.
Interventions
The efficacy and safety of 3 drugs used by the control program as anti-malarial standard treatment, artesunate, DHA-PIP and CQ, will be assessed separately in 4 different groups of patients in 3 different study sites. Pf malaria patients in Binh Phuoc and Dak Nong sites will receive Artesunate for 7 days; Pf patienst in Quang Tri and Gia Lai will recieve co-formulated DHA-PIP for 3 days; and vivax patienst in Quang Tri will receive CQ.
- Oral artesunate (50 mg/tab) will be administered at a tot
The efficacy and safety of 3 drugs used by the control program as anti-malarial standard treatment, artesunate, DHA-PIP and CQ, will be assessed separately in 4 different groups of patients in 3 different study sites. Pf malaria patients in Binh Phuoc and Dak Nong sites will receive Artesunate for 7 days; Pf patienst in Quang Tri and Gia Lai will recieve co-formulated DHA-PIP for 3 days; and vivax patienst in Quang Tri will receive CQ. - Oral artesunate (50 mg/tab) 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). - Oral dihydroartemisinin-piperaquine(DHA-PIP) will be administered at a dose of 2mg/kg/day DHA and 16mg/kg/day PIP for 3 days. - Oral chloroquine will be administered at a total dose of 25mg/kgbw (10 mg/kgbw on day0, 10mg/kgbw on day1 and 5 mg/kgbw on day2). 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
Ministry of Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
- age between 02 to 60 years old; - mono-infection with P. falciparum or P. vivax detected by microscopy; - Pf= parasitaemia of 500 – 100,000 asexual forms/ micro ml of blood; - Pv = parasitemia 250-50,000 asexual forms/ micro ml of blood; - presence of axillary temperature greater than or equal 37.5 degrees Centigrade 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.
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 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); - 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 - Single female with ages 12 – 18 years old. - a positive pregnancy test or breastfeeding. - unable to or unwilling to take contraceptives (for women of child-bearing age).
Outcome results
None listed