None listed
Conditions
Brief summary
This is an open label prospective surveillance study to confirm the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciaprum malaria in children from 6 months to 12 years of age in three provinces of Benin.
Interventions
This is a an open label single arm surveillance study to confirm the efficacy and safety of the first-line antimalarial treatment, artemether-lumefantrine, for the treatment of uncomplicated falciparum malaria in children aged between 6 months a 12 years. All eligible patients will be enrolled on day 0 and received artemether-lumefantrine as fixed-combination tablet (20 mg artemether and 120 mg lumefantrine) twice daily for 3 consecutive days. The number of tablets to be administered for each
This is a an open label single arm surveillance study to confirm the efficacy and safety of the first-line antimalarial treatment, artemether-lumefantrine, for the treatment of uncomplicated falciparum malaria in children aged between 6 months a 12 years. All eligible patients will be enrolled on day 0 and received artemether-lumefantrine as fixed-combination tablet (20 mg artemether and 120 mg lumefantrine) twice daily for 3 consecutive days. The number of tablets to be administered for each dose ( morning and evening) is based on body weight according to standard treatment (5-14 kg, 1 tb; 15-24 kg, 2 tb; 25-34 kg, 3 tb; over 35 kg 4 tb). Each dose will be administered under the supervision of a qualified study staff member. Clinical and parasitological examinations will be conducted at each of the scheduled follow-up visit on days 1,2,3,7,14,21, and 28 or any other day if symptoms re-occurred.
Sponsors
Ministere de la Sante Benin
Eligibility
Sex/Gender
All
Age
6 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
Age between 6 months and 12 years Minimum body weight of 5kg Mono-infection with plasmodium falciparum confirmed by microscopy Parasitemia between 1000-200000 asexual forms parasites per microliter Axillary temperature equal or greater than 37.5 degrees Celsius or history of fever in the past 24 hours Able to swallow oral medication Capable and willing to follow protocol requirement, including schedule of assessments Written consent from parent/guardian
Exclusion criteria
Presence of signs in children aged under 5 years, or signs of severe falciparum malaria according to WHO definition Mixed or mono infection with another Plasmodium species detected by microscopy Presence of severe malnutrition (defined as a child whose growth standard is below minus 3z score, has symmetrical oedema involving at least the feet, or has mid-upper arm circumference less than 110 mm Presence of febrile conditions due to diseases other than malaria (measles, acute lower respiratory tract infection, severe diarrhea with dehydration), or other known underlying chronic diseases (cardiac, renal and hepatic diseases, HIV/AIDS) Regular medications, which may interfere with the antimalarial pharmacokinetics History of hypersensitivity reaction or contraindications to any of the medicine(s) being tested or used as alternative treatments
Outcome results
None listed