None listed
Conditions
Brief summary
Title: Efficacy of Artemether-Lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Gurney Health Centre, Alotau, Milne Bay Province, Papua New Guinea. Purpose: Ongoing therapeutic efficacy surveillance of current first line antimalarial treatment for uncomplicated falciparum malaria. Objective: To assess the current efficacy and safety of Artemether-Lumefantrine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Gurney Health Centre, Alotau, Milne Bay Province, Papua New Guinea Study Period: April to December 2017. Study Design: One arm prospective study. Patient population: Febrile patients aged between minimum 6 months and maximum 60 years, with confirmed uncomplicated P. falciparum infection. Within the defined age group, no particular age will be exempted. Both male and female will be recruited; however, pregnant women will be excluded from the study. Sample Size: Target number of patients to be recruited is 88. Treatment(s) and follow-up: Artemether-Lumefantrine is available as a fixed-dose formulation with dispersible or standard tablets containing 20 mg of artemether and 120 mg of lumefantrine. The recommended treatment is a 6-dose regimen over a 3-day period. The treatment dosage ranges from 1.4-4 mg/kg of artemether and 10-16 mg/kg of lumefantrine. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. All artemether-lumefantrine are to be taken with fatty food. 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 Optional exploratory endpoints: The polymorphism of molecular markers for arteamisinin resistance (K13) and piperaquine resistance (plasmepsin-2).
Interventions
The study will evaluate the efficacy and safety of artemether-lumefantrine give twice daily for three days according to the recommended weight bands as follows: 1 tablet (20/120 mg) 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 and will
The study will evaluate the efficacy and safety of artemether-lumefantrine give twice daily for three days according to the recommended weight bands as follows: 1 tablet (20/120 mg) 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 and will be taken with fatty food e.g. milk. The patient will be given artemether+lumefantrine and will be followed up for 28 days.
Sponsors
Department of Health
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 to 60 years; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 250–100,000/microliter asexual forms; 4. presence of axillary temperature greater than or equal to 37.5 degree 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; (weather the patient is a temporary or permanent resident to the area is important to note, i.e. to minimize loosing study cases); and 7. informed consent from the patient or from a parent or guardian of children aged less than age of majority . 8. informed assent from any minor participant aged from 12 to age of majority years; and 9. consent for pregnancy testing from female of child-bearing age (defined as age > 12 years and sexually active) 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. haemoglobin < 8 g/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 a mid-upper arm circumference <115mm. 6. 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); 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); 9. a positive pregnancy test or breastfeeding; and 10. 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