None listed
Conditions
Brief summary
Title: Efficacy and safety of artemisinin-based combinations: artesunate+amodiaquine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum in the sites of BUHIGA, KAZIRABAGENI and KIGOBE MUTOYI in KARUZI , MAKAMBA, BUJUMBURA MAIRIE et GITEGA provinces, respectively, BURUNDI. Purpose: To assess the efficacy and safety of the first-line and second-line treatments. 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 4 sites: Buhiga, Kazirabageni, Kigobe and Mutoyi located in Karuzi , Makamba, Bujumbura Mairie and Gitega provinces, respectively. Study Period: The study will be conducted from July 2016 to March 2016. Study Design: A one arm prospective study for each drug combination. Patient population: Febrile patients aged between 6 months and 11 years with confirmed uncomplicated P. falciparum infection will be enrolled. Sample Size: 88 patients per drug per site. Artesunate+amodiaquine will be tested in all the 4 sites (352 patients) while artemether+lumefantrine will be evaluated in two sites (176 patients) 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 artesunate+amodiaquine (artesunate 4 mg/kg body weight + amodiaquine 10mg/kg body weight once daily for 3 consecutive days) and 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 is based on weight bands: one tablet to those weighing 5-14kg; two tablets for 15-24 kg; three tablets for 25-34 kg and four tablets for greater than or equal
To assess the efficacy and safety of artesunate+amodiaquine (artesunate 4 mg/kg body weight + amodiaquine 10mg/kg body weight once daily for 3 consecutive days) and 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 is based on weight bands: one tablet to those weighing 5-14kg; two tablets for 15-24 kg; three tablets for 25-34 kg and four tablets for greater than or equal to 35 kg; once daily for 3 consecutive days.. The treatment will be taken orally under direct supervision by the health worker. These two artemisinin-based combinations will be tested separately. The patient will be given either artesunate+amodiaquine or artemether+lumefantrine. Artesunate+amodaiquine will tested in all sites while artemether+lumefantrine will evaluated in two sites. Eligible subjects will be treated for three days and followed up for 28 days.
Sponsors
Ministry of Health of Burundi
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 120 Months
Healthy volunteers
No
Inclusion criteria
1. age between 6 and 120 months; 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 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 (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