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 artemether-lumfantrine for the treatment of uncomplicated Plasmodium falciparum malaria in 3 sites Luang Prabang, Khammoune and Attapeu provinces in Lao PDR. The WHO 28-day in vivo protocol will be used. People with uncomplicated falciparum malaria who meet the study inclusion criteria will be enrolled, treated on site with the ACT artemether-lumefantine 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 Lao PDR in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria.
Interventions
Single co-formulated drug treatment. Standard treatment: 6 doses of oral artemether(20mg)-lumefantrine(120mg) / tablet, given twice a day for 3 days for specific weight groups; 5-14kg = 1 tablet twice daily for 3 days; 15-24kg = 2 tablets twice daily for 3 days; 25-34kg = 3 tablets twice daily for 3 days and 35 kg and above = 4 tablets twice daily for 3 days.
The "WHO 28 day in vivo" protocol, used in this study, consists of parasite count and temperature measurements at baseline (day 0 before
Single co-formulated drug treatment. Standard treatment: 6 doses of oral artemether(20mg)-lumefantrine(120mg) / tablet, given twice a day for 3 days for specific weight groups; 5-14kg = 1 tablet twice daily for 3 days; 15-24kg = 2 tablets twice daily for 3 days; 25-34kg = 3 tablets twice daily for 3 days and 35 kg and above = 4 tablets twice daily for 3 days. The "WHO 28 day in vivo" protocol, used in this study, consists of parasite count and temperature measurements at baseline (day 0 before dosing) and on days 1, 2, 3, 7, 14, 21, 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
- age between 6 months and above; - mono-infection with P. falciparum detected by microscopy; P. falciparum parasitaemia of 250-100,000/u asexual forms; - presence of axillary temperature = 37.5 degrees 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; 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 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); and - Unmarried women age 12-18 years old - a positive pregnancy test or lactating - Unable to or unwilling to take contraceptives for pregnancy negative married women of child- bearing age.
Outcome results
None listed