None listed
Conditions
Brief summary
This is an observational study to monitor the efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in children recruited from 4 provinces of Burundi. The protocol follows the standard WHO methods for surveillance of antimalrial drug efficacy.
Interventions
Patients with confirmed falciparum malaria from 4 provinces of Burundi (Bujumbura, Makamba, Karuzi and Gitega) will be treated with artesunate (4mg/kg)-amodiaquine (10 mg/kg) once daily for three days and will be followed for up to 28 days with fixed scheduled clinical and parasitological assessements. Three formulations of fixed combination tablets of artesunate-amodiaquine will be used: 25/67.5 mg; 50/135mg and 100/270 mg). Number of tablet(s) to be adminsitered is based on body weight accor
Patients with confirmed falciparum malaria from 4 provinces of Burundi (Bujumbura, Makamba, Karuzi and Gitega) will be treated with artesunate (4mg/kg)-amodiaquine (10 mg/kg) once daily for three days and will be followed for up to 28 days with fixed scheduled clinical and parasitological assessements. Three formulations of fixed combination tablets of artesunate-amodiaquine will be used: 25/67.5 mg; 50/135mg and 100/270 mg). Number of tablet(s) to be adminsitered is based on body weight according to the national policy. Once the target number of patients have been enrolled, a second cohort will be treated with artemether (4 mg/kg)-lumefantrine 25 mg/kg) given in two daily doses for three days and will be followed for up to 28 days with fixed scheduled clinical and parasitological assessements. Fixed combination tablet containing 20 mg artemether and 120 mg lumefantrine will be used: the number of tablets to be administered for the morning and evening dose is based on body weight according to the national policy. All doses for both treatments will be administered under supervsion of medical staff.
Sponsors
Ministry of Public Health
Eligibility
Sex/Gender
All
Age
6 Months to 10 Years
Healthy volunteers
No
Inclusion criteria
children aged 6 months to 10 years monoinfection with P falciparum confirmed by microscopy parasitemia between 1000-200000 parasites (asexual) per microliter fever (equal or greater than 37.5 celsius) or history of fever within past 24 hours able to swallow oral medication ability and willingness to follow protocol procedures and schedule of assessments written informed consent from parent or guardian
Exclusion criteria
presence of danger and signs of severe malaria mixed infection or infection of than P. falciparum detected by microscopy severely malnourished fever due to other diseases (measles, acute lower respiratory tract infection, severa diarrhea); chronic or severe hepatic, renal or cardiac diseases; HIV/AIDS clinical signs of acute jaundice abnormal level of granulocytes or liver transaminases regular medication that could interfere with antimalarial pharmacokinetics; history of hypersensitivity reactions or contraindications to any medicines being used
Outcome results
None listed