None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether-lumefantrine (AL) combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria in 4 Tribal dominating states in India: Madhya Pradesh, Maharashtra, Chhattisgarh and Odisha. The objective of the study is assess the efficacy and safety artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria infections. The study will be conducted in 4 sentinel sites (Balaghat district, Madhya Pradesh; Gondia district, Maharashtra; Bastar district, Chhattisgarh; and Koraput district, Odisha). The study will be started in Sept 2016 and will be completed in August 2017. It is a one arm prospective study. The study population is febrile patients aged between 6 months and 60 years, inclusive, with confirmed uncomplicated P. falciparum infection. Female minors aged 12-17 years and unmarried females aged 18 years and above will be excluded as subjecting them to pregnancy testing is unacceptable according to the local customs and cultures. A target sample of 88 patients will be enrolled in each site. Artemether-lumefantrine (twice 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. As primary outcomes, 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. The secondary endpoints include the frequency of adverse events and frequency of molecular markers for artemisinin resistance (K13).
Interventions
To assess the efficacy and safety of artemether-lumefantrine 20mg artemether+120mg lemefantrine given (twice a day for 3 days) for the treatment of uncomplicated P. falciparum infection. Doses 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. The treatment will be given in tablets by oral. Eligible subjects will be treated for three days
To assess the efficacy and safety of artemether-lumefantrine 20mg artemether+120mg lemefantrine given (twice a day for 3 days) for the treatment of uncomplicated P. falciparum infection. Doses 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. The treatment will be given in tablets by oral. Eligible subjects will be treated for three days and followed up for 28 days. The twice daily doses of the study medicine will be administered under direct supervision.
Sponsors
Indian Council of Medical Research, (ICMR) Ministry of Health & Family welfare.
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 60 Years
Healthy volunteers
No
Inclusion criteria
1. age over 6 months to 60 years old 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 500–100,000/micro liter asexual forms; 4. presence of axillary or tympanic 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 in the case of children aged less than 18 years; 8. informed assent from any minor participant aged from 12 years to less than 18 years; and 9. consent for pregnancy testing from female of child-bearing potential of 18 years and above.
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. mixed or mono-infection with another Plasmodium species detected by microscopy; 4. presence of severe malnutrition (defined as a child aged 6-60 months whose weight-for-height is below –3 z-score, has symmetrical oedema involving at least the feet or 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 diarrhoea 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); 8. a positive pregnancy test or breastfeeding; 9. unable to or unwilling to take a pregnancy test or to use contraception for women of child-bearing age and who are sexually active; and 10. females minors of 12 to less than 18 years old.
Outcome results
None listed