None listed
Conditions
Brief summary
Title: Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for P.vivax in Myit Kyi Nar Township, Kachin State. Background: Therapeutic efficacy studies will be done in in Myit Kyi Nar Township, Kachin State in Myanmar to assess the efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for the treatment of Plasmodium vivax. Objective: to evaluate the efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria, and chloroquine for Plasmodium vivax in Myit Kyi Nar Township, Kachin State. Methods: The participants will be febrile people above 6 years with confirmed uncomplicated P. falciparum or P. vivax infection. Patients will be treated with artemether-lumefantrine twice a day over 3 days or dihydroartemisinin-piperaquine over 3 days, or chloroquine daily for 3 days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. 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 and vivax malaria.
Interventions
One arm propective evaluation with: (i) artemether-lumefantrine and (ii) dihydroartemisinin-piperaquine for the treatment of uncomplicated P. falciparum malaria; and (iii) with chloroquine for the treatment of Plasmodium vivax malaria.
Dose regimen:
Artemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrince twice a day for 3 days according to the following weight bands:5-14 kg body weight (bw): 1 tablet; 15-24 kg body
One arm propective evaluation with: (i) artemether-lumefantrine and (ii) dihydroartemisinin-piperaquine for the treatment of uncomplicated P. falciparum malaria; and (iii) with chloroquine for the treatment of Plasmodium vivax malaria. Dose regimen: Artemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg): 6-dose regimen of artemether-lumefantrince twice a day for 3 days according to the following weight bands:5-14 kg body weight (bw): 1 tablet; 15-24 kg body weight (bw): 2 tablets; 25-34 kg body weight (bw): 3 tablets, and greater than or equal to 35 kg body weight (bw): 4 tablets. All treatment will be orally taken tablets. Dihydroartemisinin-piperaquine tablets (tablet containing dihydroartemisinin 40 mg/piperaquine phophate 320 mg): 2-2.4/16-19.2 mg/kg once a day for 3 days according to the following weight bands:11-18 kg body weight (bw): 1 tablet; 19-29 kg body weight (bw): 1 1/2 tablets; 30-39 kg body weight (bw): 2 tablets and greater than or equal to 40 kg body weight (bw): 3 tablets. All treatment will be orally taken tablets. Chloroquine phophate tablets (tablet contains 150 mg base): 25 mg/kg body weight ober 3 consecutive days (10 mg/kg body weight on day 0, 10 mg/kg body weight (bw) on day 1 and 5 mg/kg body weight (bw) on day 2). All treatment will be orally taken tablets.
Sponsors
Department of Medical Research (Upper Myanmar), 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 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
*age between 6 years inclusive and above except females aged 12-17 year old inclusive; *mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/microliter asexual forms) or P. vivax detected by microscopy (parasitaemia > 250/µl asexual forms) *presence of axillary temperature equal to or more than 37.5 degrees 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; 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 below 3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 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); and *a positive pregnancy test or breastfeeding; *unable to or unwilling to take a pregnancy test or contraceptives.
Outcome results
None listed