None listed
Conditions
Brief summary
This surveillance study is a one-arm 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 the ACT artemether-lumefantrine for uncomplicated P. falciparum and P. vivax malaria and monitored for 28 days. 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(s). PCR analysis will be used to distinguish between a true recrudescence/relapse due to treatment failure and episodes of reinfection.
Interventions
Artemether-Lumefantrine(AL) drug combination (Artemether 20mg-Lumefantrine 120mg per tablet) will be administered daily for 3 days according to body weight for the treatment of uncomplecated pP.falciparum(P.f) and P.vivax (P.v) malaria. Both P.f and P.v patients will be administered AL according to the following dosage:
1). Patients between 5-14kg = 1 AL tablet will be given twice a day
2). Patients between 15-24kg = 2 AL tablets will be given twice a day
3). Patients between 25-34kg = 3 AL tabl
Artemether-Lumefantrine(AL) drug combination (Artemether 20mg-Lumefantrine 120mg per tablet) will be administered daily for 3 days according to body weight for the treatment of uncomplecated pP.falciparum(P.f) and P.vivax (P.v) malaria. Both P.f and P.v patients will be administered AL according to the following dosage: 1). Patients between 5-14kg = 1 AL tablet will be given twice a day 2). Patients between 15-24kg = 2 AL tablets will be given twice a day 3). Patients between 25-34kg = 3 AL tablets will be given twice a day 4). Patients 35kg and above = 4 AL tablets will be given twice a day In addition to AL, P.f cases will be given a single dose of 0.25mg/kg ( body weight) Primaquine(PQ) on the day of enrolment (D0). G6PD normal P.v cases will be given daily a PQ tablet ( 0.25mg/kg/day for 14 days start on D0. G6PD deficiency P.v patients will be given a weekly dose of PQ: 0.75mg/kg per week for 8 weeks start on D0. Doses of AL medicine will be administered under the supervision of a qualified member of the staff designated by principal investigater. The study patients will be observed for 30 minute aftter medicine administration for adverse reactions or vomiting. For P.f cases the single low dose will also be administered under supervision on D0. For G6PD normal P.v patients, PQ administration will be observed D0-D3 and D7. All other nine days, staff will follow up PQ administration by telephone and will confirm the number of remaining tablets at the following visit. For G6PD deficiency P.v patients, administration of PQ will be under supervision for the first 5 weeks , while the remaining 3 weeks will be follow up by telephone.
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
• Aged 6 months and above; • Mono-infection with P. falciparum and P. vivax confirmed by positive blood smear (no mixed infection); • P. falciparum parasitaemia of 250-100,000/µl asexual forms; • P. vivax parasitaemia of 250-60,000/µl asexual forms • Presence of axillary temperature greater than or equal to 37.5 °C or history of fever during the past 24 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 (Appendix 1); • 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); • 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