None listed
Conditions
Brief summary
Malaria is one of the major public health problems in Bangladesh. Out of 64 districts in the country malaria is endemic in 13 districts and 13.25 million people are at risk of the disease. Artemether-lumefantrine is the first-line drug for the treatment uncomplicated falciparum malaria. High degree of resistance of P. falciparum against chloroquine was found in the country. The wide scale use of the treatment regimen started in 2007. This study will help to measure the efficacy of artemether-lumefantrine in the treatment of uncomplicated plasmodium malaria in Bangladesh. The objective of the study is to assess the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in Ramgarh Upazila of Khagrachori district and Nykhonchori Upazila of Bandarban district in Bangladesh. The participants will be febrile people or with history of fever in the last 24 hours >6 months old with confirmed uncomplicated P. falciparum infection. Patients will be treated with 3 day-regimen of artemether-lumefantrine. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The study will be conducted from July to December, 2016. The results of this study will be used to assist the National Malaria Control Programme of Bangladesh in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria. This surveillance study is a one-arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. The proportion of study subjects experiencing therapeutic failure during the follow-up period will be used to estimate the efficacy of the study drug(s). PCR analysis will be used to distinguish between a true recrudescence due to treatment failure and episodes of reinfection. The population of interest consists of patients aged >6 months of age diagnosed with uncomplicated P. falciparum malaria attending the health complexes, and having given or whose parents or guardians (in case of children) have given an informed consent for study inclusion. The study will be conducted during the malaria transmission season from June to December 2016 with the actual data collection from July to October 2016. Safety will be assessed by recording the nature and incidence of adverse events and serious adverse events. The principal investigator will ensure that the study protocol is strictly adhered to and that all data are collected and recorded correctly on the case report form During each visit of the PI, the completed forms will be collected, data will be entered into a database by double independent data entry, according to WHO standard procedures. At a confidence level of 95% and with a precision around the estimate of 5%, at least 73 subjects need to be included. With a 20% increase to allow losses to follow-up and withdrawals during the 28-day follow-up period, 60 subjects need to be included in each of the sentinel site. Data will be analyzed using two methods: the per protocol analysis and the survival analysis.
Interventions
Oral tablet of AL (one tablet contains Artemether 20 mg+Lumefantrine 120mg), given according to body weight, twice daily for 3 days. Laboratory tests such as daily blood smear from Day 0 to Day 3 and weekly up to Day 28 are done to monitor treatment response over a 28-day period.
Sponsors
Ministry of Health and Family Affairs
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
The followings are the inclusion criteria for the study: 1. age more than 6 months; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 1000/µl to 100,000 asexual forms; 4. presence of axillary temperature equal to 37.5 °C or history of fever during the past 48 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 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
The presence of one or more of the following conditions will be the exclusion criteria for the study: • 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 to 60 months who has symmetrical oedema involving at least the feet and/or has a mid-upper arm circumference less than 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 and 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.
Outcome results
None listed