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 5 sites in Vietnam. The drugs and study sites are: AS7 in Bu Dang of Binh Phuoc, Huong Hoa of Quang Tri and Bac Ai of Ninh Thuan, DHA-PIP in Gia Lai, Quang Tri, Binh phuoc, and Dak Nong, CQ in Ninh Son of Ninh Thuan and Bu Dang of Binh Phuoc, 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 monotherapy for Pf cases and CQ for Pv cases, 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 Viet Nam in assessing the current national treatment guidelines for uncomplicated P. falciparum and P. vivax malaria.
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 9 different groups of patients in 5 different study sites. Pf malaria patients in Binh Phuoc and Ninh Thuan sites will receive Artesunate for 7 days in 2008 and in Quang Tri site in 2009. Pf malaria patients in Quang Tri, Gia Lai sites will receive DHA-PIP for 3 days in 2008 and in Binh Phuoc, Dak Nong sites in 2009. Pv malaria patients i
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 9 different groups of patients in 5 different study sites. Pf malaria patients in Binh Phuoc and Ninh Thuan sites will receive Artesunate for 7 days in 2008 and in Quang Tri site in 2009. Pf malaria patients in Quang Tri, Gia Lai sites will receive DHA-PIP for 3 days in 2008 and in Binh Phuoc, Dak Nong sites in 2009. Pv malaria patients in Ninh Thuan and Binh phuoc will receive CQ for 3 days in 2009. - 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
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
- Adults and children over 6 months old; - single Infection with P. falciparum; - Parasitaemia: 1 000–200 000 asexual forms per micro ml of blood; - Presence of axillary temperature greater than or eqqual 37.5 degrees Centigrade or history of fever within the previous 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; - Informed consent from the patient or from a parent or guardian in case of children.
Exclusion criteria
- Presence of general danger signs among children <5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions. - Mixed or mono-infection with another Plasmodium species; - Presence of severe malnutrition - Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS); - History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment; - Positive pregnancy test or lactating
Outcome results
None listed