None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Comoros Purpose: To assess the efficacy and safety of artemether-lumefantrine for treatment of uncomplicated falciparum malaria Objective: To assess the efficacy and safety artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria infections Study Sites: Pole Sud, Pole du centre et Pole du Nord de la grande ile dans l’Union des Comores. Study Period: The study started in July 2017 and will continue until March 2018. Study Design: Single arm prospective study. Patient population: Febrile patients aged between 6 months and 60 years, inclusive, with confirmed uncomplicated P. falciparum infection. Female 12 years will be excluded as subjecting them to pregnancy testing is unacceptable according to the local customs and cultures. Sample Size: 88 patients will be enrolled. Treatments and follow-up: artemether-lumefantrine (twice daily dose for 3 days) will be given. Clinical and parasitological parameters will be monitored over a 42-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: The frequency of adverse events and frequency of molecular markers for artemisinin resistance (K13)
Interventions
The study aims to assess the efficacy and safety of artemether+lumefantrine (20/120 mg in tablet) given twice daily for three days. The recommended dose by weight bands will be used 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.
All treatments will be taken orally under direct supervision by the health worker. The patient will be given artemether+lumefantrine and will be followed up for 28 da
The study aims to assess the efficacy and safety of artemether+lumefantrine (20/120 mg in tablet) given twice daily for three days. The recommended dose by weight bands will be used 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. All treatments will be taken orally under direct supervision by the health worker. The patient will be given artemether+lumefantrine and will be followed up for 28 days. Patients will be asked to attend the study facilities at scheduled days (days 1, 2, 3, 7, 14, 21, 28 and any other day, if required). If the patient fail to attend the scheduled days a designated member of the study team will visit the patient at home.
Sponsors
Ministry of Health of Comoros
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 six months and 60 years, excluding females aged 12 and above years; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 500–200,000/microliter 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 18 years.
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. Hemoglobin less than 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 has a mid-upper arm circumference below 115 mm) 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);
Outcome results
None listed