None listed
Conditions
Brief summary
Title: Therapeutic Efficacy Testing For Artemether Lumefantrine in treatment of uncomplicated Plasmodium falciparum malaria in 3 sentinel sites (Katete, Mansa and Chipata) in Zambia. Background: Therapeutic efficacy studies will be done in Zambia to assess the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria. The participants will be febrile people above 6 months except female aged 12-18, inclusive. Patients will be treated with artemether-lumefantrine twice a day over 3 days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The results of this study will be used to assist the Ministry of Health of Zambia in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Interventions
One arm prospective evaluation with artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria. Eligible subjects will be treated with artemether-lumefantrine. All patients will be followed up for 28 days.
Dose regimen: artemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrine twice a day for 3 days according to the following weight bands:5-14 kg body weight (bw): 1 tablet; 15-24 kg body weig
One arm prospective evaluation with artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria. Eligible subjects will be treated with artemether-lumefantrine. All patients will be followed up for 28 days. Dose regimen: artemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrine twice a day for 3 days according to the following weight bands:5-14 kg body weight (bw): 1 tablet; 15-24 kg body weight (bw): 2 tablets; 25-34 kg bw: 3 tablets and greater than or equal to 35 kg body weight (bw): 4 tablets. All treatment will be orally taken tablets.
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 60 Years
Healthy volunteers
No
Inclusion criteria
*age equal to or above 6 months excluding female aged 12 to 18 years; *mono-infection with P. falciparum detected by microscopy; *parasitaemia of 1,000 to 200,000/microlitre asexual forms; *presence of axillary equal to or more than 37.5 degrees centigrade 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 World Health Organization (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 below 110 mm); *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, Human Immuno Deficiency Virus /Auto Immune Deficiency Syndrome(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; *unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age.
Outcome results
None listed