None listed
Conditions
Brief summary
To study the efficacy of antimalarial drugs in India
Interventions
Artemether-lumefantrine will be administered orally twice daily to patients for 3 days. Adult patients (35kg and above) will receive dosage of 80 mg artemether and 480 mg lumefantrine twice daily for 3 days. For patients from 25 to 35 kg the dosage is 60mg artemether and 360 mg of lumefantrine twice daily for 3 days. For patients from 15 to 25 kg the dosage is 40mg artemether and 240 mg of lumefantrine twice daily for 3 days.
For patients from 5 to 15 kg the dosage is 20mg artemether and 120
Artemether-lumefantrine will be administered orally twice daily to patients for 3 days. Adult patients (35kg and above) will receive dosage of 80 mg artemether and 480 mg lumefantrine twice daily for 3 days. For patients from 25 to 35 kg the dosage is 60mg artemether and 360 mg of lumefantrine twice daily for 3 days. For patients from 15 to 25 kg the dosage is 40mg artemether and 240 mg of lumefantrine twice daily for 3 days. For patients from 5 to 15 kg the dosage is 20mg artemether and 120 mg of lumefantrine twice daily for 3 days. The first dose will be administered at the health centre by a study nurse or clinician. Every day morning doses of medicine on day 0, 1and 2 will be administered under the supervision of a qualified staff. The subsequent second dose on each day will be given at home by a parent or guardian and will be monitored by study personnel through mobile phone call or home visits if the parent/guardian is not reachable by mobile phone. All the doses will be administered after meals.
Sponsors
National Insititute of Malaria Research
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Age between 1 year to 65 years ; Mono infection with P. falciparum detected by microscopy, parasitaemia of (1000)–(100000)/microlitre asexual forms; presence of axillary great than or equal to 37.5 degrees celsius or history of fever during the past 48 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; 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, 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 contraceptives (for women of child-bearing age).
Outcome results
None listed