None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in two sites in Yemen. Purpose: To assess the efficacy of the current first and/or second line treatment policy; Objective: To assess the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Al Udayn, Ibb governorate and in Bajil, Al Hudeida governorate. Study Period: April to November 2017. Study Design: One arm prospective study. Patient population: Febrile patients aged 6 months and above, excluding female minors 12-17 years old and unmarried females aged 18 years and above, with confirmed uncomplicated P. falciparum infection. The female minors and unmarried females will be excluded as subjecting them to pregnancy testing is unacceptable according to the local customs and cultures. Sample Size: 88 patients per site. Treatment(s) and follow-up: Artemether/lumefantrine, Novartis, Basel Switzerland], a fixed combination of 20 mg of artemether and 120 mg of lumefantrine in a tablet)] will be administered according to the recommended weight bands as follows: One tablet to those weighing 5-14 kg; two tablets for 15-24 kg; three tablets for 25-34 kg and four tablets for greater or equal to 35 kg. The full course of treatment for all study patients consists of 6-doses given twice daily over 3 days. 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. Secondary endpoints: The frequency and nature of adverse events to determine the polymorphism of molecular markers for name of the antimalarial drug(s) resistance.
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 taken orally under d
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 taken orally under direct supervision by the health worker. The two drugs will be tested separately. The patient will be given artemether+lumefantrine and will be followed up for 28 days.
Sponsors
Ministry of Public Health and Population
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 Weeks
Healthy volunteers
No
Inclusion criteria
1. age 6 months and above, excluding female minors 12-17 years old and unmarried females aged 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 temperature greater or equal to 37.5 degrees C 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 female of child-bearing potential and from their parent or guardian if under the age of majority years.
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 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); 8. a positive pregnancy test or breastfeeding; and 9. unable to or unwilling to take pregnancy test or to use contraception for married women.
Outcome results
None listed