None listed
Conditions
Brief summary
Title: Efficacy and safety of chloroquine for Plasmodium vivax in Kawthaung – Mawhtaung, Tanintharyi Region and Kyainseikkyi-Myawaddy, Kayin State in Myanmar To assess the efficacy of chloroquine against P. vivax malaria to support updating of the national policy. The study will be conducted from May to December 2017.It is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with chloroquine for uncomplicated P. vivax malaria and monitored for 28 days. Febrile patients with uncomplicated P. vivax malaria attending the study clinic, who are aged 6 years and above, both sexes will be included. Total 70 patients for each specie at each study site. Clinical and parasitological parameters will be monitored over a 28 day follow-up , to evaluate the efficacy of chloroquine .
Interventions
Treating malaria patients with chloroquine in standard dose and course described in Malaria Manual for private the general practice.
Chloroquine tablets containing 250 mg chloroquine phosphate over three days will be given orally (10mg/kg/day on the first two days and 5 mg/kg on the 3rd day) (total dose 25mg base/kg) as the treatment of choice for P. vivax infection and for radical curative treatment with primaquine oral tablet (0.25mg base/kg/day for 14 days). If there is mild G6PD deficienc
Treating malaria patients with chloroquine in standard dose and course described in Malaria Manual for private the general practice. Chloroquine tablets containing 250 mg chloroquine phosphate over three days will be given orally (10mg/kg/day on the first two days and 5 mg/kg on the 3rd day) (total dose 25mg base/kg) as the treatment of choice for P. vivax infection and for radical curative treatment with primaquine oral tablet (0.25mg base/kg/day for 14 days). If there is mild G6PD deficiency then 0.75mg/kg is given once weekly for 8 weeks. To monitor adherence, fist dose of treatment was given directly observed by Field team leader, usually medical officer, then following doses by malaria volunteers. Empty blistered cards were recollected. The trial objective is to monitor the efficacy of CQ, but primaquine is given to kill liver stage hypnozoites to prevent relapse and also to block transmission of vivax malaria to other.
Sponsors
Ministry of Health and Sports
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• patients aged 6 year and above • mono-infection with P. vivax detected by microscopy (parasitaemia > 250/µl asexual forms); • presence of axillary temperature greater than or equal to 37.5 °C 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; • informed consent from the patient or from a parent or guardian in the case of children aged less than age of majority; • informed assent from any minor participant aged from 12 to age of majority years; and • consent for pregnancy testing from female of child-bearing age(defined as age > 17 years and sexually active).
Exclusion criteria
• presence signs of severe falciparum malaria according to the definitions of WHO • mixed or mono-infection with another Plasmodium species detected by microscopy; • female aged from 12 and 17 years; • Body weight under 20 kg; • 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); • a positive pregnancy test or breastfeeding; and • unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age(defined as age > 12 years and sexually active).
Outcome results
None listed