None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Alikadam Upazila and Lama Upazila of Bandarban district and Baghaichari Upazila of Rangamati districts, Bangladesh. Purpose: To assess the efficacy of the current first line and second line treatment policy Objective: To assess the efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated P. falciparum malaria infections. Study Sites: Alikadam Upazila of Bandarban district, Lama Upazila of Bandarban district and Baghaichari Upazila of Rangamati district. Study Period: 30 January 2023 to 31 December 2023. Study Design: This surveillance study is two arm prospective study. Patient population: Febrile patients aged more than 6 months with confirmed uncomplicated P. falciparum infection. Exclusion: pregnancy, breast feeding mother, young girls aged 12-18 years old and contraindication to Artemether-Lumefantrine. Sample Size: A total of 360 patients (180 patients for each drug combination to be tested) will be enrolled from 3 upazilas, 120 patients of each upazila (60 patients for each drug combination). Treatment(s) and follow-up: Clinical and parasitological parameters will be monitored over a 28-day follow-up period for artemether-lumefantrine and 42-day follow up period for dihydroartemisinin-piperaquine to evaluate drug efficacy of both the drug combinations. 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: • to determine the polymorphism of molecular markers (K13) for Artemisinin resistance
Interventions
Clinical and parasitological efficacy of artemether-lumefantrine and dihydro-artemisinin piperaquine in patients aged more than 6 months, suffering from uncomplicated falciparum malaria, by determining the proportion with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy.
The study drugs will be Artemether-lumefantrine and Dihydroartemisinin-piperaquine. Artemether-lumefantrine will be admin
Clinical and parasitological efficacy of artemether-lumefantrine and dihydro-artemisinin piperaquine in patients aged more than 6 months, suffering from uncomplicated falciparum malaria, by determining the proportion with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. The study drugs will be Artemether-lumefantrine and Dihydroartemisinin-piperaquine. Artemether-lumefantrine will be administered orally for 6 doses over 3 days and Dihydroartemisinin-piperaquine will be administered orally daily for 3 days (total 3 doses). Artemether-lumefantrine tablets will contain 20 mg artemether and 120 mg lumefantrine (detail provided in the attached protocol). In addition, Tab Primaquine (0.25mg/kg) will be given orally with the first dose of ACT. Dihydroartemisinin-piperaquine will contain 40 mg dihydroartemisinin and 320 mg piperaquine phosphate (Detail provided in the attached protocol). Like Artemether-lumefantrine group Tab Primaquine (0.25mg/kg) will be given with the first dose of ACT. Both the study drugs will be provided orally. For monitoring adherence to the interventions the subjects will be hospitalised for initial 3 days and will be provided Directly Observed treatment by the Senior Staff Nurse. The choice of treatment either by the artemether-lumefantrine or dihydroartemesinin-piperaquine will be dependent on both the research assistant and the subject as this is not at randomised trial. As the dihydroartemisinin-peperaquine tablets are not available at this moment (for which procurement is under process), the study will be started with the tablet artemether-lumefantrine. When tablet dihydroartemisinin-peperaquine will be available (we are expecting it will be available soon) then the treatment choice will be dependent upon discussion between patients and research assistant.
Sponsors
Ministry of Health and Family Welfare, Bangladesh
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
• age more than 6 months; • mono-infection with P. falciparum detected by microscopy; • parasitaemia of 1000/µl to 100,000 asexual forms; • presence of tympanic temperature greater than or equal to 37.5 °C or history of fever during the past 48 h; • ability to swallow oral medication; • ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; • informed consent from the patient or from a parent or guardian in the case of children aged less than 18 years; • informed assent from any minor participant aged from 12 to 18 years; and • 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
• presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO; • weight under 5 kg; • any mixed or mono-infection with other Plasmodium species detected by microscopy; • presence of severe malnutrition defined as a child aged 6-60 months who has symmetrical edema involving at least the feet and/or has a mid-upper arm circumference < 115 mm) • 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); • regular medication, which may interfere with antimalarial pharmacokinetics; • history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); • a positive pregnancy test or breastfeeding; and • unable to or unwilling to take pregnancy test or to use contraception for married women of child-bearing age. • minors (below 18 years of age) who have achieved menarche will be excluded from the study. • Unmarried women
Outcome results
None listed