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Trial registered on ANZCTR


Registration number
ACTRN12614000215628
Ethics application status
Approved
Date submitted
9/01/2014
Date registered
28/02/2014
Date last updated
28/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of artesunate 7days therapy for the treatment of uncomplicated Plasmodium falciparum malaria in Pa-an (Mon State) in Myanmar.
Scientific title
A study evaluating the efficacy and safety of artesunate for the treatment of uncomplicated plasmodium falciparum malaria in Pa-An (Mon State) in Myanmar
Secondary ID [1] 283885 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 290870 0
Condition category
Condition code
Infection 291228 291228 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients will be administered artesunate in oral tablet form (50 mg of artesunate per tablet,) at a dose of 4mg/kg/day for 7 days. Each dose administration will be observed and recorded.
Intervention code [1] 288560 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291223 0
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 great than or equal to37.5 degrees celsius; parasitaemia on day 3 greater than or equal to 25 percent of count on day 0.
Late treatment failure: danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 /42 in patients who did not previously meet any of the criteria of early treatment failure; presence of parasitaemia on any day between day 4 and day 28/42 with axillary temperature greater than or equal to 37.5 degrees celcius (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 28/42 with axillary temperature
great than 37.5 degrees celsius in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure
The day a patient is enrolled and receives the first dose of medicine is designated ‘day 0’. All antimalarial treatment will be given by a study team member under supervision. Thereafter, patients are required to undergo regular clinical reassessment. Blood films for parasite counts will be made twice a day (12 hourly) until parasite clearance, and then on day 7, and then weekly for the remainder of the follow-up period, i.e. on days 14, 21, and 28. Clinical reassessment will be sufficiently thorough to ensure patient safety and will include assessment not only for potential treatment failure but also for potential adverse reactions to the medicine. Additionally, blood films will be obtained whenever parasitological reassessment is requested by the clinical staff.
Timepoint [1] 291223 0
Day 7, 14, 21 and 28
Secondary outcome [1] 306270 0
Nil
Timepoint [1] 306270 0
Nil

Eligibility
Key inclusion criteria
male and female age older than 18 years; mono-infection with P. falciparum detected by microscopy (parasitaemia of 10 000-100 000/microlitres asexual forms or P. vivax detected by microscopy (parasitaemia greater than 250/microlitres asexual forms); presence of axillary greater than or equal to 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of signs of severe falciparum malaria according to the definitions of WHO; mixed or mono-infection with another Plasmodium species detected by microscopy; presence of febrile conditions due to diseases other than malaria (e.g. 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); and a positive pregnancy test or breastfeeding unable to or unwilling to take a pregnancy test or contraceptives (for women of child-bearing age); patients presenting with splenectomy.

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 having symptoms of malaria meeting the inclusion criteria
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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/01/2014
Actual
20/01/2014
Date of last participant enrolment
Anticipated
28/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5734 0
Myanmar
State/province [1] 5734 0
Pa-An (Mon state)

Funding & Sponsors
Funding source category [1] 288527 0
Charities/Societies/Foundations
Name [1] 288527 0
The World Health Organization
Country [1] 288527 0
Switzerland
Primary sponsor type
Hospital
Name
Clinical Research Unit ( Malaria), Defense Services General Hospital
Address
Mingaladon, Myanmar
Country
Myanmar
Secondary sponsor category [1] 287237 0
None
Name [1] 287237 0
Nil
Address [1] 287237 0
Nil
Country [1] 287237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290389 0
Director of Medical Serivces
Ethics committee address [1] 290389 0
The republic of the Union of Myanmar office of the Commander In Chief (Army) Directorate of medical services, Yangon
Ethics committee country [1] 290389 0
Myanmar
Date submitted for ethics approval [1] 290389 0
25/07/2013
Approval date [1] 290389 0
26/08/2013
Ethics approval number [1] 290389 0
Ethics committee name [2] 290390 0
Ethical Review Committee, World Health Organization
Ethics committee address [2] 290390 0
Avenue Appia 20
CH1211 Geneva 20
Ethics committee country [2] 290390 0
Switzerland
Date submitted for ethics approval [2] 290390 0
30/10/2013
Approval date [2] 290390 0
18/12/2013
Ethics approval number [2] 290390 0
RPC626

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

Contacts
Principal investigator
Name 45446 0
Dr Khin Phyu Pyar
Address 45446 0
Consultant Physician
Head of Clinical Research Unit (Malaria)
No (1) Defense Services General Hospital (1000 beds), Mingaladon., Myanmar
Country 45446 0
Myanmar
Phone 45446 0
+9513135195
Fax 45446 0
Email 45446 0
[email protected]
Contact person for public queries
Name 45447 0
Dr Sai Aik Hla
Address 45447 0
Physician/Member of Clinical Research Unit (Malaria)
No (1) Defense Services General Hospital (1000 beds), Mingaladon, Myanmar
Country 45447 0
Myanmar
Phone 45447 0
+9513135195
Fax 45447 0
Email 45447 0
[email protected]
Contact person for scientific queries
Name 45448 0
Dr Khin Phyu Pyar
Address 45448 0
Consultant Physician
Head of Clinical Research Unit (Malaria)
No (1) Defense Services General Hospital (1000 beds), Mingaladon., Myanmar
Country 45448 0
Myanmar
Phone 45448 0
+9513135195
Fax 45448 0
Email 45448 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.