None listed
Conditions
Brief summary
To monitor the efficacy of artesunate plus sulphadoxine-pyrimethamine in the treatment of uncomplicated falciparum malaria in the malaria control center Asadabad in Kunar province of Afghanistan
Interventions
People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with a combiantion of artesunate plus sulphadoxine-pyrimethamine (AS plus SP) and observed for 42 days. Artesunate tablets (100 mg) will be administered orally once a day at a dose of 4 mg/kg per day for three consecutive days. Sulphadoxine-pyrimethamine tablets (500/25 mg) will be administered orally once a day for three days. The number of tablets to be administered is based on patient ag
People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with a combiantion of artesunate plus sulphadoxine-pyrimethamine (AS plus SP) and observed for 42 days. Artesunate tablets (100 mg) will be administered orally once a day at a dose of 4 mg/kg per day for three consecutive days. Sulphadoxine-pyrimethamine tablets (500/25 mg) will be administered orally once a day for three days. The number of tablets to be administered is based on patient age /5-11 months = half tablet; 1-6 years = 1 tablet; 7-13 years= 2 tablets; 13 years and over = 3 tablets). The dosing regimen of artesunate plus sulphadoxine-pyrimethamine correspond to the standard of care for the treatment of acute uncomplicated malaria in Afghanistan.
Sponsors
Research Department, Ministry of Publich Health, Afgahnistan
Eligibility
Sex/Gender
All
Age
4 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Age above 4 months, except females aged between 12 and 17 years Mono-infection with P. falciparum detected by microscopy Parasitemia 500-100,000 per microliter, asexual forms Axillary or tympanic temperature greater than 37.5 C or history of fever during the past 24 hours Ability to swallow oral medication Ability and willingness to follow protocol procedures and visit schedule Informed consent from patient or from parent or legal guardian for children under 16 years
Exclusion criteria
Presence of general danger signs of severe malaria in children under 5 years Mixed or mono-infection with another Palsmodium species Pregnancy or breastfeeding Presence of severe malnutrition Presence of febrile conditions due to diseases other than malaria Regular medication which may interfere with the antimalarial pharmacokinetics History of hypersensitivity reactions or contraindications to any study medications. Unable to or unwilling to take pregnancy test or contraceptives due to social-cultural reason
Outcome results
None listed