None listed
Conditions
Brief summary
To monitor the efficacy of artemether-lumefantrine in the treament of uncomplicated falciparum malaria in three sentinel sites in Nepal
Interventions
Treatment with artemether lumefantrine will be given orally in 6 doses twice daily over 3 days as per standard of care in Nepal. Each tablet contains 20 mg of artemether and 120 mg of lumefantrine. The number of tablets to be administered at each dose will be based on body weight (5-14 kg = 1 tablet; 15-24 kg = 2 tablets, 25-34 kg = 3 tablets and, 35 kg and over = 4 tablets). All patients will be confined in the hospital for three days and will return for efficacy and safety follow-up assessm
Treatment with artemether lumefantrine will be given orally in 6 doses twice daily over 3 days as per standard of care in Nepal. Each tablet contains 20 mg of artemether and 120 mg of lumefantrine. The number of tablets to be administered at each dose will be based on body weight (5-14 kg = 1 tablet; 15-24 kg = 2 tablets, 25-34 kg = 3 tablets and, 35 kg and over = 4 tablets). All patients will be confined in the hospital for three days and will return for efficacy and safety follow-up assessments at day 7, 14, 21 and 28 post-dosing.
Sponsors
Ministry of Health and Population, Nepal
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Patients above 6 months, except girls between 12-18 years and unmarried women above 18 years Malaria positive p. falciparum mono-infection with a parasite density of 1'000-100'000 parasites per microliter Axillary temperature of 37.5 C or greater or history of fever during the past 24 hours Ability to swallow oral medication Ability to comply with study procedures Written informed consent from patient or from parent or leagl guardian in case of children
Exclusion criteria
Presence general danger signs of severe and complicated malaria Mixed or mono-infection with another Plasmodium species Severe malnutrition Febrile conditions due to disease other than malaria Regular medication, whcih may interfere with antimalarial pharmacokinetics. History of hypersensitivity reactions to the medicinal products preganancy or breastfeeding Girls between 12-18 years, or unamrried women above 18 years Women unable or unwilling to take contraceptives
Outcome results
None listed