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Trial registered on ANZCTR


Registration number
ACTRN12614000216617
Ethics application status
Approved
Date submitted
10/01/2014
Date registered
28/02/2014
Date last updated
28/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for Plasmodium vivax in Ta Beik Kyin Township, Mandalay Region and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria in Ta-mu township, Sagaing Region
Scientific title
A study evaluating the efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for plasmodium vivax malaria in in Ta Beik Kyin Township, Mandalay Region and Ta-mu township, Sagaing Region, Myanmar
Secondary ID [1] 283886 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 290871 0
Condition category
Condition code
Infection 291229 291229 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For Plasmodium falciparum:
The first 80 patients will receive Artemether-Lumefantrine (in a fixed combination of 20 mg of artemether and 120 mg of lumefantrine in a tablet) will be administered orally in a twice daily dose for three days, as follows: One tablet to those weighing 5-14kg; two tablets to children with 15-24 kg and three tablets to children weighing 25-35 kg. Four tablets to those over 35kg. The full course of treatment for all study patients consists of 6-doses given twice daily.

The next 80 patients will be administered dihydroartemisinin-piperaquine. A fixed dose of 40 mg dihydroartemisinin and 320 mg piperaquine phosphate) will be administered orally as a weight per dose regimen of 2.25 and 18 mg/kg per dose of dihydroartemisinin and piperaquine phosphate. The medicine will be given a daily dose over three days.

For plasmodium vivax: Chloroquine phosphate 150 mg base per tablet will be given a total dose of 25 mg per kg. body weight as: 10 mg per kg body weight for days 1 and 2 while 5 mg per kg body weight on day 3.

All drug administration is supervised over the period of three days.
Intervention code [1] 288561 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291224 0
The study end-point is the classification assigned to a patient. Valid study end-points include: treatment failure, completion of the follow-up period without treatment failure, loss to follow-up, withdrawal from study, and protocol violation. At all times, the well-being of the patient will take priority over his or her continuation in the study.

Early treatment failure: danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia;parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature; parasitaemia on day 3 with axillary temperature equal to 37.5 degrees celsius; parasitaemia on day 3 equals 25percent of count on day 0.
Late treatment failure:
1 Late clinical failure - danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 (day 42) in patients who did not previously meet any of the criteria of early treatment failure; or presence of parasitaemia on any day between day 4 and day 28 with axillary temperature equal to or great than 37.5 degrees celsius ( or history of fever) in patients who did not previously meet any of the criteria of early treatment failure

Late parasitological failure - presence of parasitaemia on any day between day 7 and day 28 with axillary temperature great than 37.5 degrees celsius in in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure

Adequate clinical and parasitological response - absence of parasitaemia on day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure
Timepoint [1] 291224 0
A standard physical examination will be performed at baseline (day 0 before dosing) and on days 1, 2, 3, 7, 14, 21, 28, 35 and 42 days. A complete medical history, demographic information and contact details will be taken at baseline.
Secondary outcome [1] 306271 0
nil
Timepoint [1] 306271 0
nil

Eligibility
Key inclusion criteria
Criteria are. ge between 6 years inclusive and above; mono-infection with plasmodium falciparum detected by microscopy (parasitaemia of 500-100,000/microlitre asexual forms) or plasmodium vivax detected by microscopy (parasitaemia great than 250/microlitre asexual forms); presence of axillary equal to or great than 37.5 degrees celcius 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.
Minimum age
6 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
presence 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 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, 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 for falciparum malaria; and unable to or unwilling to take a pregnancy test or contraceptives.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients on site having malaria symptoms
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5741 0
Myanmar
State/province [1] 5741 0
Ta Beik Kyin Township, Mandalay Region
Country [2] 5767 0
Myanmar
State/province [2] 5767 0
Ta-mu township, Sagaing Region

Funding & Sponsors
Funding source category [1] 288528 0
Charities/Societies/Foundations
Name [1] 288528 0
World Health Organization
Address [1] 288528 0
Avenue Appia 20
CH 1211 Geneve 20
Country [1] 288528 0
Switzerland
Primary sponsor type
Government body
Name
Department of Medical Research (Upper Myanmar)
Address
Ward 16, Pyin Oo Lwin township, Mandalay Region
Country
Myanmar
Secondary sponsor category [1] 287238 0
None
Name [1] 287238 0
Nil
Address [1] 287238 0
Country [1] 287238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290391 0
Republic of the Union of Myanmar, Ministry of Health
Ethics committee address [1] 290391 0
Department of Medical Research (Upper Myanmar), Ward 16, Pyin Oo Lwin township, Mandalay Region
Ethics committee country [1] 290391 0
Myanmar
Date submitted for ethics approval [1] 290391 0
Approval date [1] 290391 0
22/11/2013
Ethics approval number [1] 290391 0
Ethics committee name [2] 290392 0
Ethical Review Committee, World Health Organization
Ethics committee address [2] 290392 0
Avenue Appia 20
Ch 1211 Geneva 20
Ethics committee country [2] 290392 0
Switzerland
Date submitted for ethics approval [2] 290392 0
Approval date [2] 290392 0
20/11/2013
Ethics approval number [2] 290392 0
RPC599

Summary
Brief summary
To study the efficacy of antimalarial drugs in Myanmar
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45450 0
Dr Khin Lin
Address 45450 0
Deputy Director General /Head
Parasitology Research Division
Department of Medical Research (Upper Myanmar)
Wad No. (16) , Pyin Oo Lwin township, Mandalay Region
Country 45450 0
Myanmar
Phone 45450 0
+95 05 50436
Fax 45450 0
Email 45450 0
dr.khinlin.dir@gmail.com
Contact person for public queries
Name 45451 0
Dr Moe Kyaw Myint
Address 45451 0
Research Scientist
Parasitology research division
Department of Medical Research (Upper Myanmar)
Wad No. (16) , Pyin Oo Lwin township, Mandalay Region
Country 45451 0
Myanmar
Phone 45451 0
+95 085 40436
Fax 45451 0
Email 45451 0
dr.myiintmoekyaw@gmail.com
Contact person for scientific queries
Name 45452 0
Dr Khin Lin
Address 45452 0
Deputy Director General /Head
Parasitology Research Division
Department of Medical Research (Upper Myanmar)
Wad No. (16) , Pyin Oo Lwin township, Mandalay Region
Country 45452 0
Myanmar
Phone 45452 0
+95 05 50436
Fax 45452 0
Email 45452 0
dr.khinlin.dir@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results