Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000244202
Ethics application status
Not yet submitted
Date submitted
20/10/2008
Date registered
12/05/2009
Date last updated
12/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective risk assessment of bacteraemia and other infectious complications in patients undergoing Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
Scientific title
Prospective risk assessment of bacteraemia and other infectious complications in patients undergoing Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal masses
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incidence of bacteremia following EBUS-TBNA biopsy of mediastinal or hilar masses 3846 0
Condition category
Condition code
Respiratory 4037 4037 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will determine the proportion of people developing bacteraemia following EBUS-TBNA through performance of blood cultures, to be taken prior to and immediately after performance of EBUS-TBNA. Observation of participants will cease after collection of peripheral blood immediately after the procedure.
The study will be conducted over a six month period.
Intervention code [1] 3572 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4939 0
incidence of bacteraemia, as detected by culture of peripheral blood drawn immediately after completion of the procedure
Timepoint [1] 4939 0
5 minutes following completion of procedure
Secondary outcome [1] 8325 0
Incidence of clinically relevant infection, as determined by clinical follow-up, directed by usual physician care.
Timepoint [1] 8325 0
within 72 hrs of completion of procedure

Eligibility
Key inclusion criteria
Patients undergoing EBUS-TBNA for investigation of mediastinal and/or hilar masses
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
fever
clinically evident infection (anywhere)
known bacteraemia
antibiotic treatment within 1 week of procedure

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4025 0
Self funded/Unfunded
Name [1] 4025 0
Daniel Steinfort
Country [1] 4025 0
Australia
Primary sponsor type
Individual
Name
Dr Daniel Steinfort
Address
c/- Dept Respiratory Medicine
Royal Melbourne Hospital
Grattan St
Parkville 3050
Country
Australia
Secondary sponsor category [1] 3618 0
None
Name [1] 3618 0
Address [1] 3618 0
Country [1] 3618 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6105 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 6105 0
Ethics committee country [1] 6105 0
Date submitted for ethics approval [1] 6105 0
19/11/2008
Approval date [1] 6105 0
Ethics approval number [1] 6105 0
2008.239

Summary
Brief summary
We hypothesize that bacteraemia occurs in a small proportion of people following needle puncture of the tracheal wall during Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lymph nodes.
The purpose of the study is to confirm the proportion, and also to identify the likely bacteriologic agents. This will allow appropriate guidelines of use of antibiotic prophylaxis and choice of empiric antibiotic therapy for those developing clinical infection following EBUS-TBNA
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29050 0
Address 29050 0
Country 29050 0
Phone 29050 0
Fax 29050 0
Email 29050 0
Contact person for public queries
Name 12207 0
Daniel Steinfort
Address 12207 0
c/- Dept Respiratory Medicine
Royal Melbourne Hospital
Grattan St
Parkville
Victoria 3050
Country 12207 0
Australia
Phone 12207 0
+61 3 9342 7708
Fax 12207 0
+61 3 9342 8493
Email 12207 0
[email protected]
Contact person for scientific queries
Name 3135 0
Daniel Steinfort
Address 3135 0
c/- Dept Respiratory Medicine
Royal Melbourne Hospital
Grattan St
Parkville
Victoria 3050
Country 3135 0
Australia
Phone 3135 0
+61 3 9342 7708
Fax 3135 0
+61 3 9342 8493
Email 3135 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.