None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum will be evaluated. Objective: To assess the efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated P. falciparum malaria infections in four sentinel sites. Study Sites: study will be conducted in 4 sites: in Bangui: (i) Complex Pediatric of Bangui ; (ii) Centre de sante of Lakouanga and (iii) Centre de sante of Bede Combattant; and in Boali: (iv) Centre de sante de Boali. Study Period: The study will be conducted from November 2016 to December 2017. Study Design: A one arm prospective study. Patient population: Febrile patients aged between 6 months and 12 years with confirmed uncomplicated P. falciparum infection will be enrolled. Sample Size: 88 patients per site giving a total of 352 patients. Treatments and follow-up: artemether+lumefantrine (twice daily for 3 days) will be given. 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
To assess the efficacy and safety of artemether+lumefantrine (20 mg artemether and 120 mg lumefantrine in a tablet) for the treatment of uncomplicated P. falciparum infection. The doses of artemether+lumefantrine are based on weight bands: one tablet to those weighing 5 to14kg; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for greater than or equal to 35 kg. The treatment will be taken orally under direct supervision by the health worker. Eligible subjects will be treated tw
To assess the efficacy and safety of artemether+lumefantrine (20 mg artemether and 120 mg lumefantrine in a tablet) for the treatment of uncomplicated P. falciparum infection. The doses of artemether+lumefantrine are based on weight bands: one tablet to those weighing 5 to14kg; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for greater than or equal to 35 kg. The treatment will be taken orally under direct supervision by the health worker. Eligible subjects will be treated twice daily for three days and followed up for 28 days.
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 12 Years
Healthy volunteers
No
Inclusion criteria
1. age between 6 month and 12 years; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 1000 - 200000/mocroliter asexual forms; 4. presence of axillary temperature greater than or equal 37.5 degrees cntigrade 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 or guardian;
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; 2. weight under 5 kg; 3. haemoglobin less than 8g/dl; 4. mixed or mono-infection with another Plasmodium species detected by microscopy; 5. presence of severe malnutrition (defined as a child aged 6-60 months who has a mid-upper arm circumference < 115 mm); 6. 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); 7. regular medication, which may interfere with antimalarial pharmacokinetics; 8. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
Outcome results
None listed