Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Teknaf Upazila of Cox’s Bazar district, Lama Upazila of Bandarban district and Kalmanda Upazila of Netrakona district in Bangladesh
Efficacy (adequate clinical and parasitological response-ACPR) as well failure (early treatment failure-ETF, late clinical failure-LCF, late parasitological failure-LPF) of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria patients in Teknaf Upazila of Cox’s Bazar district, Lama Upazila of Bandarban district and Kalmanda Upazila of Netrakona district in Bangladesh.
Ministry of Health and Family Welfare
270 participants
Sep 15, 2012
Interventional
Conditions
Summary
Title: Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Teknaf Upazila of Cox’s Bazar district, Lama Upazila of Bandarban district and Kalmanda Upazila of Netrakona district in Bangladesh. Background: Malaria is one of the major public health problems in Bangladesh. It is endemic in 13 out of 64 districts in the country and 10.9 million people are at risk of the disease. Artemether-lumefantrine is the first-line drug and quinine for 7 days plus either tetracycline for 7 days or doxycycline for 7 days is the second-line drug for the treatment uncomplicated falciparum malaria. High degree of resistance of P. falciparum against chloroquine was found in the country. Increasing trend of resistance was found against all antimalarials in use in the country. Based on the evidences the Government of Bangladesh has updated the treatment regimen of malaria with artemether-lumefantrine as the first-line drug replacing CQ in 2004. The wide scale use of the treatment regimen started in 2007. The studies conducted so far have shown excellent efficacy and tolerability of artemether-lumefantrine. One of the important activities of the Malaria and Parasitic Diseases Control Unit is to monitor the efficacy of the antimalarials in use and to have the updated information for revising the antimalaria drug regimen when needed. This study will help to measure the efficacy of artemether-lumefantrine in the treatment of uncomplicated plasmodium malaria in Bangladesh. Objective: To assess the efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in Teknaf Upazila of Cox’s Bazar district, Lama Upazila of Bandarban district and Kalmanda Upazila of Netrakona district in Bangladesh. Methods: An antimalarial drug efficacy trial will be conducted in Teknaf Upazila of Cox’s Bazar district, Lama Upazila of Bandarban district and Kalmanda Upazila of Netrakona district in Bangladesh. The participants will be febrile people or with history of fever in the last 24 hours, aged >6 months (except girls above 12 years) 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 2012 to March 2013 and to be extended until June 2013 if necessary to get enough sample size. 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.
Eligibility
Inclusion Criteria6
- All patients above 6 months of age except girls between 12-18 years and unmarried women;
- Malaria positive P. falciparum mono-infection with parasite density of 1,000-100,000 parasites/micro-litre;
- Axillary temperature > 37.5 degree Centigrade or history of fever during the past 24 hours;
- 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.
Exclusion Criteria9
- Presence of general danger signs or other signs of severe and complicated falciparum malaria according to current WHO definitions.
- Mixed or mono-infection with another Plasmodium species detected by microscopy;
- Presence of severe malnutrition (defined as a child who has a mid-upper arm circumference < 110 mm)
- Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS);
- Regular medication, which may interfere with antimalarial pharmacokinetics;
- History of hypersensitivity reactions or contraindications to the medicine being tested;
- A positive pregnancy test or breastfeeding;
- Unmarried women and girls between 12-18 years;
- Unable to or unwilling to take contraceptives (for married women of child-bearing age)
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Interventions
a) Treatment with artemether-lumefantrine will be given as per the national drug regimen 6 doses over 3 days. After the first dose second dose will be taken 8 hours after. Then the remaining four doses will be taken 12 hourly. Each tablet contains 20 mg of artemether and 120 mg of lumefantrine. b) Mode of Administration-Oral tablet
Locations(1)
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ACTRN12612000935831