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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12614000215628 |
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Date of registration:
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28/02/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of artesunate 7days therapy for the treatment of uncomplicated Plasmodium falciparum malaria in Pa-an (Mon State) in Myanmar.
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Scientific title:
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A study evaluating the efficacy and safety of artesunate for the treatment of uncomplicated plasmodium falciparum malaria in Pa-An (Mon State) in Myanmar |
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Date of first enrolment:
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20/01/2014 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12614000215628.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
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Phase:
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Phase 3
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Countries of recruitment
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Myanmar
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Contacts
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Name:
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Dr Khin Phyu Pyar
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Address:
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Consultant Physician
Head of Clinical Research Unit (Malaria)
No (1) Defense Services General Hospital (1000 beds), Mingaladon., Myanmar
Myanmar |
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Telephone:
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+9513135195 |
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Email:
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khinphyupyar@gmail.com |
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Affiliation:
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Name:
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Dr Sai Aik Hla
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Address:
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Physician/Member of Clinical Research Unit (Malaria)
No (1) Defense Services General Hospital (1000 beds), Mingaladon, Myanmar
Myanmar |
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Telephone:
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+9513135195 |
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Email:
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saiaikhla@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Malaria;
Malaria
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Infection - Other infectious diseases
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Intervention(s)
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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.
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Primary Outcome(s)
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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.[Day 7, 14, 21 and 28]
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Secondary Outcome(s)
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Nil[Nil]
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Source(s) of Monetary Support
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The World Health Organization
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Ethics review
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Status: Approved
Approval date:
Contact:
Director of Medical Serivces
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Status: Approved
Approval date:
Contact:
Ethical Review Committee, World Health Organization
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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