None listed
Conditions
Brief summary
Title: Efficacy of artesunate 4 mg/day over 7 days for the treatment of uncomplicated Plasmodium falciparum malaria in Kawthaung (Tanintharyi Division) in Myanmar. Background: The artemisinin resistance is not just on the Thai-Cambodia border, but may have extended to or emerged on the Thai-Myanmar, China-Myanmar and Cambodia-Viet Nam borders, confirmatory artemisinin monotherapy in vivo studies and molecular fingerprinting of parasite genomes to track artemisinin resistance (gene flow) moving around the region is even more important now. Of the data presented from these countries, the slow parasite clearance time (PCT) following treatment with artemisinin derivatives was of greatest concern. With combination therapy, artesunate usually provides the initial rapid decrease of PCT, with 95% of patients clearing peripheral parasitaemia within 48 hours, hence if the PCT is slow despite the drug being in the blood at adequate levels, this could provide evidence that it is failing. Objective: To assess the efficacy of artesunate 4 mg/day over 7 days for the treatment of uncomplicated Plasmodium falciparum malaria in Kawthaung (Tanintharyi Division) in Myanmar. Methods: An antimalarial drug efficacy trial will be conducted in Kawthaung (Tanintharyi Division), Mzanmar. The participants will be febrile people > 18 years with confirmed uncomplicated P. falciparum infection. Patients will be treated with artesunate 28 mg/kg over 7 days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The study will be conducted from October to December 2010. The results of this study will be used to assist the Ministry of Health of Myanmar in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria and mapping the extent of artesunate resistance.
Interventions
One arm propective evaluation with artesunate 4 mg/day over 7 days for the treatment of uncomplicated Plasmodium falciparum malaria.
Dose regimen:
artesunate tablets (Tablet containing 50 mg): 4mg/kg/day
for 7 days. Each dose administration will be observed and recorded.
Sponsors
Department of Medical Research (Lower Myanmar)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
*age equal to or more than 18 years; *mono-infection with P. falciparum detected by microscopy (parasitaemia of 1000-100000/microliterl asexual forms; *presence of axillary equal to or more than 37.5 degrees centigrade 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 signs of severe falciparum malaria according to the definitions of World Health Organization (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 below 110 mm); *presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, Human Immuno Deficiency Virus /Auto Immune Deficiency Syndrome(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 (include this criterion only if adults are included); *unable to or unwilling to take a pregnancy test or contraceptives (for women of child-bearing age); *previous antimalarial drug intake in the past 48 hours; *patients presenting with splenectomy.
Outcome results
None listed