None listed
Conditions
Brief summary
Title: Efficacy and safety of artesunate+amodiaquine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum in Lambarene Gabon. Purpose: To assess the efficacy and safety of the first-line and second-line treatments for uncomplicated malaria. Objective: To assess the efficacy and safety of artesunate+amodiaquine and artemether+lumefantrine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: study will be conducted in Lambarene in Gabon. Study Period: The study will be conducted from December 2016 to July 2017. Study Design: A one arm prospective study for each drug combination. The patients will be assigned to the drugs sequentially. Patient population: Febrile patients aged 6 months to 12 years with confirmed uncomplicated P. falciparum infection will be enrolled. Sample Size: 60 patients per drug. Treatments and follow-up: artesunate+amodiaquine (daily dose for 3 days) and 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 (given twice a day for 3 days) and artesunate-amodiaquine (given daily for 3 days) for the treatment of uncomplicated P. falciparum infection. Doses of artemether-lumefantrine (20/120) will be administered according to the recommended weight bands as follows: 1 tablet to those weighing 5 to 14kg; 2 tablets for 15 to 24 kg;3 tablets for 25 to34 kg and 4 tablets for equal or greater than 35 kg. For the artesunate-amodiaquine, 4 mg/kg a
To assess the efficacy and safety of artemether-lumefantrine (given twice a day for 3 days) and artesunate-amodiaquine (given daily for 3 days) for the treatment of uncomplicated P. falciparum infection. Doses of artemether-lumefantrine (20/120) will be administered according to the recommended weight bands as follows: 1 tablet to those weighing 5 to 14kg; 2 tablets for 15 to 24 kg;3 tablets for 25 to34 kg and 4 tablets for equal or greater than 35 kg. For the artesunate-amodiaquine, 4 mg/kg artesunate and 10 mg/kg amodiaquine will be give daily. The treatment will be given in tablets by oral under direct supervision. Eligible subjects will be treated for three days and followed up for 28 days.
Sponsors
Ministry of Health and Population Gabon
Study design
Allocation
Non-randomised trial
Intervention model
Other
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 6 months to 12 years old 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 1000–100,000/microliter asexual forms; 4. presence of axillary temperature greater than or equal 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 patient or from a 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 below 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 symmetrical oedema involving at least the). 6. 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 (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