None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether-lumefantrine, artesunate-amodiaquine and dihydroartemisinin+piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Dolisie in Congo. Objective: To assess the efficacy and safety artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated P. falciparum malaria infections Study Sites: study will be conducted in two public health facilities in Dolisie. Study Period: The study period will cover October to December 2016. Study Design: Single arm prospective study for each drug. Patient population: Febrile patients aged between 6 months and 11 years with confirmed uncomplicated P. falciparum infection. Sample Size: 88 patients will be enrolled in each treatment arm. Treatments and follow-up: artemether-lumefantrine (twice daily doses for 3 days) and artesunate-amodiaquine (daily dose for 3 days) will be given under direct supervision. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy and safety. Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Day 3 malaria positivity rate will determined. Secondary endpoints: 1. The frequency of adverse events. 2. Frequency of molecular markers for artemisinin resistance (K13).
Interventions
The efficacy and safety of artemether-lumefantrine (twice daily doses for 3 days) and artesunate-amodiaquine (one daily dose for 3 days) for the treatment of uncomplicated P. falciparum malaria will be evaluated. For artemether-lumefantrine, each tablet contains 20 mg artemether and 120 mg lumefantrine, A total target dose ranges 5-24 mg/kg bw of artemether and 29-144 mg/kg bw of lumefantrine. Artemether+lumefantrine will be given by weight bands: 1 tablet for children 5 to less than 15kg, 2 ta
The efficacy and safety of artemether-lumefantrine (twice daily doses for 3 days) and artesunate-amodiaquine (one daily dose for 3 days) for the treatment of uncomplicated P. falciparum malaria will be evaluated. For artemether-lumefantrine, each tablet contains 20 mg artemether and 120 mg lumefantrine, A total target dose ranges 5-24 mg/kg bw of artemether and 29-144 mg/kg bw of lumefantrine. Artemether+lumefantrine will be given by weight bands: 1 tablet for children 5 to less than 15kg, 2 tablets per dose for children 15 to less than 25kg, 3 tablets for children 25 to less than 35 kg. For artesunate+amodiaquine treatment, a daily dose of 4 mg of artesunate/kg body weight and 10 mg of amodiaquine base/kg body weight will be given. The treatment will be given orally in tablets. Eligible children will be treated for three days and followed up for 28 days. The daily doses of the study medicines will be administered under direct supervision by the study team. Patients will be enrolled sequentially. The first cohort of recruited patients will be treated with artesunate+amodiaquine. When 88 patients have been enrolled and treated with artesunate+amodiaquine, the recruitment of the second cohort will begin; patients in the second cohort will be treated with artemether+lumefantrine and recruitment will continue until the target number of patients was reached.
Sponsors
Ministry of Health and Population
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 11 Years
Healthy volunteers
No
Inclusion criteria
1. age between 6 months and 11 years. 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 1000–200000/microliter asexual forms; 4. presence of axillary temperature equal to or greater than 37.5 degrees centigrade or history of fever during the past 24 h; 5. ability to swallow oral medication; 6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; 7. informed consent from the parent of children
Exclusion criteria
1. 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); 2. weight under 5 kg; 3. mixed or mono-infection with another Plasmodium species detected by microscopy; 4. presence of severe malnutrition defined as a child aged 6-60 months who has a mid-upper arm circumference < 115 mm; 5. 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); 6. regular medication, which may interfere with antimalarial pharmacokinetics; 7. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
Outcome results
None listed