None listed
Conditions
Brief summary
This study is an open 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 ASMQ and low dose primaquine for both Pf and Pv, and monitored for 42 days and 28 days for Pv. The follow-up will consist 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 true recrudescence due to treatment failure and episodes of reinfection.
Interventions
One oral tablet for children contains 25 mg artesunate+ 55 mg Mefloquine (ASMQ), and for adults it contains 100 mg artesunate+ 220 mg Mefloquine. Drug will be administered under direct supervision according to body weight, once daily for 3 days for both P. vivax and P. falciparum.
For children:
5-8 kg one tablet daily for 3 days
9-17 kg two tablets daily for 3 days
For adults:
18-29 kg one tablet daily for 3 days
Equal to or more than 30 kg 2 tablets daily for 3 days
Oral prim
One oral tablet for children contains 25 mg artesunate+ 55 mg Mefloquine (ASMQ), and for adults it contains 100 mg artesunate+ 220 mg Mefloquine. Drug will be administered under direct supervision according to body weight, once daily for 3 days for both P. vivax and P. falciparum. For children: 5-8 kg one tablet daily for 3 days 9-17 kg two tablets daily for 3 days For adults: 18-29 kg one tablet daily for 3 days Equal to or more than 30 kg 2 tablets daily for 3 days Oral primaquine will be administered under direct supervision as a single 15-mg adult dose (0.25 mg base/kg) on day 0 for P. falciparum cases only, and once daily (0.25 base/kg) for 14 days for G6PD defficient P. vivax participants.
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
- Age between aged between 6 months and above - Mono-infection with P. falciparum and P. vivax confirmed by positive blood smear (no mixed infection); - P. falciparum parasitaemia of 250 to 100,000 per µl asexual forms; - P. vivax parasitaemia of 250 to 60,000 per µl asexual forms - Presence of axillary temperature equal or more then 37.5 °C 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; - 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 more than 12 years and sexually active) and from their parent or guardian if under the age of majority years.
Exclusion criteria
-presence of general danger signs in children aged under 12 years or signs of severe falciparum malaria according to the definitions of WHO - female aged from 12 years and age of majority - weight under 5 kg; - haemoglobin less than 8 g per dl -mixed or mono-infection with another Plasmodium species detected by microscopy; - presence of severe malnutrition defined as a child aged between 6to 60 months whose weight-for-high is below –3 z-score - presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea 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); - glucose-6-phosphate dehydrogenase deficiency for patient treated with 14 day primaquine; - unmarried women 12 to 18 years old; - 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 more than 12 years and sexually active).
Outcome results
None listed