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Trial registered on ANZCTR
Registration number
ACTRN12609000016235
Ethics application status
Approved
Date submitted
9/10/2008
Date registered
8/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
A randomised cross over pilot study of inhaled tobramycin as a treatment option for hospitalised patients with cystic fibrosis versus standard treatment of intravenous tobramycin
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Scientific title
Is inhaled tobramycin as effective as intravenous tobramycin and potentially less toxic for treating acute exacerbations of lung infection in those patients with cystic fibrosis (CF) who are chronically colonised with Pseudomonas aeruginosa?
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
3746
0
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Condition category
Condition code
Infection
3924
3924
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Each participant will receive either IV tobramycin at the dose they received on their last admisson (usually 7-10mg/kg) once daily for 14 days or they will receive inhaled tobramycin at a dose of 300mg twice a day for 14 days. Once thier treatment has been completed they will cease these medications and will receive the other arm of the study on their next admission. Their admissions must be a minimum of 6 weeks apart.
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Intervention code [1]
3461
0
Treatment: Drugs
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Comparator / control treatment
Intravenous tobramycin will be given for 14 days at the same dose as their previous admission. Therapeutic drug monitoring will be carried out to ensure adequate levels are being achieved without increasing the risk of toxicity. On their next admisson they will receive inhaled tobramycin
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Control group
Active
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Outcomes
Primary outcome [1]
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Improvement in lung function which will be measured using spirometry. Forced Expiratory Volume in 1 second (FEV1) expressed as % predicted will be compared.
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Assessment method [1]
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Timepoint [1]
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Pre-treatment (either in clinic before they are admitted or on their first day of admission), on the last day of their treatment, next clinic appointment (usually 6 weeks after the end of treatment)
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Primary outcome [2]
4819
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Time until need next admission needed by the patient for treatment of an exacerbation of their lung infection
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Assessment method [2]
4819
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Timepoint [2]
4819
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Time until their next admission will be recorded in weeks until they are re-admitted for an exacerbation of their lung infection
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Primary outcome [3]
4820
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Alteration in renal function will be measured using urine beta2-microglobulin and serum creatinine (which will also be used to measure creatinine clearance by using equations)
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Assessment method [3]
4820
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Timepoint [3]
4820
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Bloods will be taken before they receive their first dose of antibiotics on day 1 of their admission, bloods will also be taken on day 8 of their admission. Urine samples will be taken on the first day of their admission and on day 14 of their admission and then at their next clinic appointment (usually 6 weeks after the end of treatment)
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Secondary outcome [1]
8140
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Weight
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Assessment method [1]
8140
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Timepoint [1]
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They will be weighed on day one and day 14 of their admission and then again at their next clinic appointment (usually 6 weeks after the end of treatment)
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Secondary outcome [2]
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Patients perception of how they are feeling using a quality of life questionnaire
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Assessment method [2]
8141
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Timepoint [2]
8141
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This will be administered on day 1 and day 14 of their treatment
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Secondary outcome [3]
8142
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Presence or changes in antibiotic resistance patterns to Pseudomonas aeruginosa by sending sputum samples to microbiology were they will test the cultures for sensitivities
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Assessment method [3]
8142
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Timepoint [3]
8142
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On day 1 of their admission(unless a sample was collected in clinic before they were admitted), on day 14 of their treatment and at their next clinic appointment (usually 6 weeks after the end of treatment)
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Eligibility
Key inclusion criteria
Diagnosis of cystic fibrosis, chronically colonised with Pseudomonas aeruginosa, Forced Expiratory Volume in 1 second (FEV1) > 25%, having an exacerbation of their lung infection
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Minimum age
6
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who are pyrexial with a temperature of >38.0C , allergic to aminoglycosides, patients with calculated creatinine clearance <50mL/min/1.73m2
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a simple randomisation order generation using the toss of a coin
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/10/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
1190
0
5000
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Funding & Sponsors
Funding source category [1]
3993
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Other
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Name [1]
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Society of Hospital Pharmacists of Australia
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Address [1]
3993
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PO Box 1774
Collingwood VIC 3066
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Country [1]
3993
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Australia
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Primary sponsor type
Hospital
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Name
Royal Adelaide Hospital
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Address
North Terrace
Adelaide
SA 5000
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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University of South Australia
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Address [1]
3584
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GPO Box 2471
Adelaide
SA 5001
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Country [1]
3584
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Australia
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Other collaborator category [1]
450
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Hospital
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Name [1]
450
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Women's and Children's Hospital
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Address [1]
450
0
King William Road
North Adelaide
SA 5006
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Country [1]
450
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
6068
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Royal Adelaide Hospital Research Ethics Committee
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Ethics committee address [1]
6068
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North Terrace
Adelaide
SA 5000
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Ethics committee country [1]
6068
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Australia
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Date submitted for ethics approval [1]
6068
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Approval date [1]
6068
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01/05/2008
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Ethics approval number [1]
6068
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080315
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Ethics committee name [2]
6069
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Children, Youth and Womens Health Service Human Research Ethics Committee
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Ethics committee address [2]
6069
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King William Road
North Adelaide
SA 5006
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Ethics committee country [2]
6069
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Australia
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Date submitted for ethics approval [2]
6069
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Approval date [2]
6069
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16/09/2008
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Ethics approval number [2]
6069
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2065
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Ethics committee name [3]
6070
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University of South Australia Human Research Ethics Committee
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Ethics committee address [3]
6070
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GPO Box 2471
Adelaide
SA 5001
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Ethics committee country [3]
6070
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Australia
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Date submitted for ethics approval [3]
6070
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Approval date [3]
6070
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22/09/2008
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Ethics approval number [3]
6070
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P030/08
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Summary
Brief summary
This study hopes to show that when tobramycin is given via inhalation in those patients with cystic fibrosis who are sick enough to need intravenous (into a vein) antibiotics, the levels in the lung are adequate for effective bacteria killing and that they recover from the acute infection. The study will be undertaken in all eligible patients who are admitted to the hospital for treatment of an exacerbation of their lung infection.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
28974
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Country
28974
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Phone
28974
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Fax
28974
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Email
28974
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Contact person for public queries
Name
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Natalie Soulsby
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Address
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R3-06, Sansom Institute
Reid Buliding, University of South Australia
Frome Road
SA 5000
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Country
12131
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Australia
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Phone
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+61 8 8302 1241
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Fax
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Email
12131
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[email protected]
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Contact person for scientific queries
Name
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Natalie Soulsby
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Address
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R3-06, Sansom Institute
Reid Buliding, University of South Australia
Frome Road
SA 5000
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Country
3059
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Australia
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Phone
3059
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+61 8 8302 1241
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Fax
3059
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Email
3059
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[email protected]
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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.
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