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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
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?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 3746 0
Condition category
Condition code
Infection 3924 3924 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 3461 0
Treatment: Drugs
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
Control group
Active

Outcomes
Primary outcome [1] 4818 0
Improvement in lung function which will be measured using spirometry. Forced Expiratory Volume in 1 second (FEV1) expressed as % predicted will be compared.
Timepoint [1] 4818 0
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)
Primary outcome [2] 4819 0
Time until need next admission needed by the patient for treatment of an exacerbation of their lung infection
Timepoint [2] 4819 0
Time until their next admission will be recorded in weeks until they are re-admitted for an exacerbation of their lung infection
Primary outcome [3] 4820 0
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)
Timepoint [3] 4820 0
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)
Secondary outcome [1] 8140 0
Weight
Timepoint [1] 8140 0
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)
Secondary outcome [2] 8141 0
Patients perception of how they are feeling using a quality of life questionnaire
Timepoint [2] 8141 0
This will be administered on day 1 and day 14 of their treatment
Secondary outcome [3] 8142 0
Presence or changes in antibiotic resistance patterns to Pseudomonas aeruginosa by sending sputum samples to microbiology were they will test the cultures for sensitivities
Timepoint [3] 8142 0
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)

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
Minimum age
6 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
Allocation is not concealed
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
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 in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1190 0
5000

Funding & Sponsors
Funding source category [1] 3993 0
Other
Name [1] 3993 0
Society of Hospital Pharmacists of Australia
Address [1] 3993 0
PO Box 1774
Collingwood VIC 3066
Country [1] 3993 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 3584 0
University
Name [1] 3584 0
University of South Australia
Address [1] 3584 0
GPO Box 2471
Adelaide
SA 5001
Country [1] 3584 0
Australia
Other collaborator category [1] 450 0
Hospital
Name [1] 450 0
Women's and Children's Hospital
Address [1] 450 0
King William Road
North Adelaide
SA 5006
Country [1] 450 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6068 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 6068 0
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 6068 0
Australia
Date submitted for ethics approval [1] 6068 0
Approval date [1] 6068 0
01/05/2008
Ethics approval number [1] 6068 0
080315
Ethics committee name [2] 6069 0
Children, Youth and Womens Health Service Human Research Ethics Committee
Ethics committee address [2] 6069 0
King William Road
North Adelaide
SA 5006
Ethics committee country [2] 6069 0
Australia
Date submitted for ethics approval [2] 6069 0
Approval date [2] 6069 0
16/09/2008
Ethics approval number [2] 6069 0
2065
Ethics committee name [3] 6070 0
University of South Australia Human Research Ethics Committee
Ethics committee address [3] 6070 0
GPO Box 2471
Adelaide
SA 5001
Ethics committee country [3] 6070 0
Australia
Date submitted for ethics approval [3] 6070 0
Approval date [3] 6070 0
22/09/2008
Ethics approval number [3] 6070 0
P030/08

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28974 0
Address 28974 0
Country 28974 0
Phone 28974 0
Fax 28974 0
Email 28974 0
Contact person for public queries
Name 12131 0
Natalie Soulsby
Address 12131 0
R3-06, Sansom Institute
Reid Buliding, University of South Australia
Frome Road
SA 5000
Country 12131 0
Australia
Phone 12131 0
+61 8 8302 1241
Fax 12131 0
Email 12131 0
natalie.soulsby@unisa.edu.au
Contact person for scientific queries
Name 3059 0
Natalie Soulsby
Address 3059 0
R3-06, Sansom Institute
Reid Buliding, University of South Australia
Frome Road
SA 5000
Country 3059 0
Australia
Phone 3059 0
+61 8 8302 1241
Fax 3059 0
Email 3059 0
natalie.soulsby@unisa.edu.au

No data has been provided for results reporting
Summary results
Not applicable