None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Zhob of Balochistan province and Khyber Agency of FATA, Pakistan Purpose: To assess the efficacy and safety of new alternate First line treatment policy Objective: To assess the efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: District Headquarter Hospital in district Zhob of Balochistan province and Rural Health Centre Ali Masjid in Khyber Agency FATA, Pakistan Study Period: From September 2017 to June 2018 Study Design: Single arm prospective study. Patient population: Febrile patients aged 6 months and above excluding 12-17 old female minors and unmarried females aged 18 years and above, with confirmed uncomplicated P. falciparum infection. The female minors and unmarried females will be excluded as it is culturally inappropriate to ask this group pregnancy test. Sample Size: 88 patients will be enrolled in each site, totally 176 patients for both sites. Treatment(s) and follow-up: artemether+lumefantrine (20/120) oftwice daily dose for three days , administered under direct observation, will be evaluated. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. 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 be determined. Secondary endpoints: (i) the frequency of adverse events, (ii) proportion of polymorphism of molecular markers for Sulfadoxine /pyrimethamine and artemisinin resistance (K13).
Interventions
To assess the efficacy and safety of artemether-lumefantrine (containing 20 mg artemether+ 120 mg lumefantrine in each tablet) will be given twice daily for three days according to the recommended weight bands as follows: 1 tablet to those weighing 5 to 14 kg; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for equal or greater than 35 kg. The total target dose ranges are 5-24 mg/kg bw of artemether and 29-144 mg/kg bw of lumefantrine.
All treatments will be given orally unde
To assess the efficacy and safety of artemether-lumefantrine (containing 20 mg artemether+ 120 mg lumefantrine in each tablet) will be given twice daily for three days according to the recommended weight bands as follows: 1 tablet to those weighing 5 to 14 kg; 2 tablets for 15 to 24 kg; 3 tablets for 25 to 34 kg and 4 tablets for equal or greater than 35 kg. The total target dose ranges are 5-24 mg/kg bw of artemether and 29-144 mg/kg bw of lumefantrine. All treatments will be given orally under direct supervision by the health worker. The patient will be followed up for 28 days
Sponsors
Ministry of National Health Services Regulations and Coordination
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 between 6 months and above with the exception of 12-17 years old female minors and unmarried females above 18 years and above; 2. Mono-infection with P. falciparum detected by microscopy; 3. Parasitaemia of 500 – 200000 per microL asexual forms; 4. Presence of axillary or tympanic temperature greater or equal to 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 to 17 years; and 9. Consent for pregnancy testing from married female aged 18 years and above.
Exclusion criteria
1. Presence of general danger signs in children aged under 12 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 who has a mid-upper arm circumference below 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); 8. A positive pregnancy test or breastfeeding of married women aged 18 years and above; and 9. Unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active.
Outcome results
None listed