None listed
Conditions
Brief summary
Evaluation of the efficacy and safety of Artemether+ Lumefantrine (Coartem®) with low-dose Primaquine for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in three sites of Savanakhet, Salavanh, and Attopue province, Lao PDR. To assess the efficacy of current first line treatment policy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum and P. vivax malaria infections. Study Sites: Three provinces of Savanakhet (5 districts of Phin, Sepon, Nong, Vilabury, and Thapangtong), Salavanh (2 provincial hospitals (public and Military) and 3 districts of Samouai, Taoi and Toumlan), and Attopue (4 districts of Phouvong, Sansay, Sanamsay, and Saysetha; and 1 Military hospital) Study Period: From August 2022 to September 2023 Study Design: This surveillance study is a one arm prospective study Patient population: Febrile patients aged between 6 months and 60, with confirmed uncomplicated P. falciparum and P. vivax infection, except females aged 12-18 years old, as it is culturally sensitive to request pregnancy test for young unmarried women. Sample Size: Total of 300 patients to be enrolled 150 P.falciparum and 150 P.vivax cases. Each study site/province will recruit 100 cases, in which 50 cases maximum of P.falciparum and 50 cases maximum of P.vivax) Treatment(s) and follow-up: Artemether-lumefantrine drug combination (Artemether 20mg / lumefantrine 120 mg per tablet), twice a day will be administered over 3 days according to body weight to a total of 6 doses. Primaquine will be administered as a single 15-mg adult dose (0.25 mg base/kg) on day 0 for uncomplicated P. falciparum cases, and once daily (0.25 base/kg) for 14 days for G6PD normal or weekly dose (0.75 base/kg) for 8 weeks for G6PD deficient P. vivax cases. The correct drug dosage will be determined from the dosing chart . 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 Exploratory endpoints: to determine the polymorphism of molecular markers for artemisinin resistance.
Interventions
Study is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. Artemether-lumefantrine drug combination will be administered for 3 days according to body weight a total of 6 doses, weight groups: 5-14kg= 1 tablet twice daily for 3 days; 15-14kg = 2 tablets twice daily for 3 days; 25-34kg= 3 tablets twice daily for 3 days; and 35kg and above = 4 tablets twice daily for 3 days. The target dose range: a total dose of 5-2
Study is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. Artemether-lumefantrine drug combination will be administered for 3 days according to body weight a total of 6 doses, weight groups: 5-14kg= 1 tablet twice daily for 3 days; 15-14kg = 2 tablets twice daily for 3 days; 25-34kg= 3 tablets twice daily for 3 days; and 35kg and above = 4 tablets twice daily for 3 days. The target dose range: a total dose of 5-24mg/kg bw of artemether and 29-144mg/kg bw of lumefantrine. Detail dosage tablet can be seen in annex 3 of the attached study protocol. Primaquine treatment will be administered as a tablet for oral mode. Primaquine will be administered as a single 15-mg adult dose ( 0.25mg base/kg) on day 0 for uncomplicated P.falciparum cases, and once daily (0.25mg base /kg) for 14 days for G6PD normal or weekly dose (0.75mg base /kg) for 8 weeks for G6PD deficiency P.vivax case. for treatment of uncomplicated P.falciparum and P.vivax malaria and monitored for 28 days measurement at baseline ( day 0 before dosing ) and on days 1,2,3,7,14,21,28. The following up of malaria vivax radical treatment compliance scheme had been existing in sub-district level including community level. Communication mechanism set up with following up from was developed and used, and reporting / refering of potential adverse event case to higher facility management.
Sponsors
Ministry 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
• aged 6 months up to 60 years old; • mono-infection with P. falciparum and P. vivax confirmed by positive blood smear (no mixed infection); • P. falciparum parasitaemia of 250-100,000/µl asexual forms; • P. vivax parasitaemia of 250-60,000/µl asexual forms • presence of axillary temperature equal or more than 37.5 °C or history of fever during the past 24 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; and • Informed consent from the patient or from a parent or guardian in the case of children. • informed assent from any minor participant aged from 12 to 18 years; and • consent for pregnancy testing from female of child-bearing age (defined as age > 12 years and sexually active).
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 ); • mixed or mono-infection with another Plasmodium species detected by microscopy; • presence of severe malnutrition (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 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); • Women age 12-18 years old • a positive pregnancy test or lactating • Unable to or unwilling to take contraceptives for pregnancy negative married women of child- bearing age.
Outcome results
None listed