None listed
Conditions
Brief summary
This is a surveillance study to monitor the safety and efficacy of the fixed combination of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in children and adults. Patients will be recruited from 8 sentinel sites located in 8 malarious provinces of Zimbabwe. The primary outcome is the proportion of patients with PCR-adjusted adequate clinical and parasitological response accroding to WHO protocol (2009).
Interventions
This is a single-arm open label study to monitor the efficacy of artemether-lumefantrine, the first-line antimalarial in Zimbabwe. Eligible patients will be treated with fixed combination tablet containing 1.5 mg base artemether and 12 mg base lumefantrine. The number of tablets per dose will be determined according to body weight as per standard of care. Patients will be administered the dose by study staff twice a day for three consecutive days. Patients will be seen daily for the first 3 day
This is a single-arm open label study to monitor the efficacy of artemether-lumefantrine, the first-line antimalarial in Zimbabwe. Eligible patients will be treated with fixed combination tablet containing 1.5 mg base artemether and 12 mg base lumefantrine. The number of tablets per dose will be determined according to body weight as per standard of care. Patients will be administered the dose by study staff twice a day for three consecutive days. Patients will be seen daily for the first 3 days and then will return to the health center for clinical and parasitological evaluation on days 7, 14, 21 and 28 or any other day if symptoms re-occurred.
Sponsors
Ministry of Health and Child Welfare
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Age 6 months and above; Mono-infection with P. falciparum detected by microscopy; Parasitaemia between 1000 to 100,000 per microliter asexual forms; Axillary temperature equal or greater than 37.5 degrees C or history of fever within the past 24 hours; Ability to swallow oral medication; Ability and willingness to comply with the study protocol for the duration of the study including the study visit schedule; Informed consent from the patient or parent Resident within 5 km radius from study site
Exclusion criteria
Presence of general danger signs in children under 5 years or signs of severe malaria Mixed or mono-infection with another Plasmodium species detected by microscopy; Presence of severe malnutrition (according to WHO definitions); 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; Regular medication which may interfere with antimalarial pharmacokinetics; History of hypersensitivity reaction or contraindications to any of the medicines being tested or used as alternative treatment; Positive pregnancy test or breastfeeding (for women of child-bearing age); Unable or unwilling to take a preganancy test or contraceptives; Resident outside 5 km radius from study site
Outcome results
None listed