None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether+lumefrantine for the treatment of uncomplicated Plasmodium falciparum malaria in Tak and Ranong provinces in Thailand Background: Current first-line treatment for P. falciparum in Thailand is a 3-day artesunate-mefloquine combination. The second-line treatment is 7-day quinine-doxycycline combination. Study conducted in 2008 in 5 sentinel sites revealed high efficacy of the 3-day artesunate-mefloquine combination (96.8-100%). In 2009, the efficacy of the artesunate-mefloquine combination declined to 87-92.7% in 4 sentinel sites. The monitoring the efficacy of the first line treatment to generate valuable information for updating the national treatment policy is critical. Objective: To assess the efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Tak, and Ranong provinces of Thailand Methods: Antimalarial drug efficacy trials will be conducted in 2 sites for uncomplicated falciparum infection. The participants will be febrile patients aged 6 months and above with confirmed uncomplicated P. falciparum infection. Falciparum malaria patients will be treated with Artemether-lumefantrine (Coartem 'Registered Trademark') combination. A total dose of artemether 2mg/kg and lumefantrine 12 mg/kg two times a day for three days. Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug efficacy for falciparum malaria. The study will be conducted from May 2011 - May 2012. The results of this study will be used to assist the Ministry of Public Health of Thailand in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria.
Interventions
Artemether-lumefantrine (Coartem 'Registered Trademark') combination. A total dose of artemether 2mg/kg and lumefantrine 12 mg/kg (One tablet contains 20 mg artemether and 120 mg lumefantrine) two times a day for three days will be given.
Sponsors
Bureau of Vector-Borne Diseases
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 6 months and above; -Mono-infection with Plasmodium falciparum detected by microscopy -P. falciparum parasitaemia of 500-1000000/ul asexual forms -presence of axillary or tympanic temperature equal or more than 37.5C 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
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 or other known underlying chronic or severe diseases -Regular medication, which may interfere with antimalarial pharmacokinetics -history of hypersensitivity reactions or contraindications to any of the medicine being tested or used as alternative treatment -Female of child-bearing potential with ages 12-17 years old inclusive -A positive pregnancy test or breastfeeding -Unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age
Outcome results
None listed