Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000489695
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective double blind randomised clinical trial of 70% ethanol to treat proven or suspected catheter related sepsis in haematology patients.
Scientific title
A prospective double blind randomised clinical trial of 70% ethanol to treat proven or suspected catheter related sepsis in haematology patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Proven or suspected central venous catheter sepsis. 611 0
Condition category
Condition code
Blood 683 683 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Routine antimircobials with the additon of daily 2 hourly locks of 70% ethanol. This intervention/control will continue until a clinical decision is made to stop the antimircobials.
Intervention code [1] 460 0
Treatment: Drugs
Comparator / control treatment
control (haparin / saline) instilled into the lumen of the central venous catheter
Control group
Placebo

Outcomes
Primary outcome [1] 833 0
To assess the efficiacy of ethanol in the teatment of proven and suspected catheter related sepsis.
Timepoint [1] 833 0
Primary outcome [2] 834 0
Primary endpoint will be resolution of symptoms and signs of sepsis.
Timepoint [2] 834 0
Secondary outcome [1] 1646 0
Prevention of recurrence of catheter related sepsis.
Timepoint [1] 1646 0

Eligibility
Key inclusion criteria
Proven catheter related sepsis (same organism in both the peripheral blood and central line culture or from the FAS brush). Suspected CRS > 1000 organisms in either FAS sample or Central line blood culture. Consents to participate in the trial Haematological Malignancy Bone Marrow Transplantation.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known allergy to Ethanol Elevated LFTs (2.5 times above the upper normal range). Known history of Alcoholism. Pregnant of lactating women, Positive cultures both peripherally and centrally but NOT the same organism.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There was one unblinded pharmacist who kept the randomsations in a different department to where the study was being conducted. Randomsation occurred by fax.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation was performed using Mircosoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 199 0
New Zealand
State/province [1] 199 0

Funding & Sponsors
Funding source category [1] 758 0
Self funded/Unfunded
Name [1] 758 0
Country [1] 758 0
Primary sponsor type
Individual
Name
Dr Alan Pithie
Address
Country
Secondary sponsor category [1] 626 0
None
Name [1] 626 0
none
Address [1] 626 0
Country [1] 626 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2005 0
Upper Southern Region Ethics committee
Ethics committee address [1] 2005 0
Ethics committee country [1] 2005 0
New Zealand
Date submitted for ethics approval [1] 2005 0
Approval date [1] 2005 0
Ethics approval number [1] 2005 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35962 0
Address 35962 0
Country 35962 0
Phone 35962 0
Fax 35962 0
Email 35962 0
Contact person for public queries
Name 9649 0
Alan Pithie
Address 9649 0
Christchurch Hospital
PO Box 4710
Christchurch
Country 9649 0
New Zealand
Phone 9649 0
+64 3 3640640
Fax 9649 0
Email 9649 0
[email protected]
Contact person for scientific queries
Name 577 0
Joanne Sanders
Address 577 0
Canterbury Health Labs
PO Box 151
Christchurch 8001
Country 577 0
New Zealand
Phone 577 0
+64 3 3640377
Fax 577 0
+64 3 3640750
Email 577 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.