Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000028303
Ethics application status
Approved
Date submitted
19/12/2016
Date registered
9/01/2017
Date last updated
9/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Sinus microbiome: a comparison between the healthy sinus and Chronic Rhinosinusitis
Scientific title
The sinus microbiome: a comparison between the healthy sinus and chronic rhinosinusitis
Secondary ID [1] 290707 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis 301265 0
Condition category
Condition code
Infection 301023 301023 0 0
Studies of infection and infectious agents
Respiratory 301229 301229 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A total of eight swabs will be taken from each participant with chronic rhino sinusitis (CRS) at only one time point. Specifically, two swabs will be taken from each participant at each of the following locations: the vestibule, the nasopharynx, the nasal cavity and the throat. A biopsy of the middle aspect of the anterior turbinate at only one time point will also be taken from those CRS patients that are undergoing endoscopic sinus surgery. and then the resultant swabs and biopsy tissue will be analysed using both microbiology and genetic techniques.
Intervention code [1] 296596 0
Not applicable
Comparator / control treatment
Controls will be participants that have healthy sinuses and, therefore, they will be individuals who do not have chronic rhino sinusitis. Similar to cases, a total of eight swabs will be taken from each control participant at only one time point. Specifically, two swabs will be taken from each of the following locations: the vestibule, the nasopharynx, the nasal cavity and the throat. Biopsies will not be taken from control participants.
Control group
Active

Outcomes
Primary outcome [1] 300439 0
This observational study will investigate the presence or absense of different bacterial strains in the sinuses of the participants. The swabs will be assessed by laboratory techniques that identify the presence of a large variety of different bacterial strains. Using these techniques, approximately 70-100 different bacterial strains are usually found in each swab sample.
Timepoint [1] 300439 0
The day that the swab sample was taken from the participant.
Primary outcome [2] 300641 0
The presence or absense of different fungal strains in the sinuses of the participants. The laboratory teqniques used will be able to identify a large variety of different fungal strains. This is an observational study investigating the different microbes that are present inside the sinuses.
Timepoint [2] 300641 0
The time that the swab was taken.
Primary outcome [3] 300642 0
The presence or absense of different viral strains in the sinuses of the participants. The presence or absense of different viral strains in the sinuses of the participants. The laboratory teqniques used will be able to identify a large variety of different viral strains. This is an observational study investigating the different microbes that are present inside the sinuses.
Timepoint [3] 300642 0
The time that the swab was taken. Each participant had swabs taken at one time point only.
Secondary outcome [1] 329985 0
Sinus infection symptoms of the participants as measured by the SNOT 22 questionnaire.
Timepoint [1] 329985 0
The day that the swab sample was taken.
Secondary outcome [2] 330530 0
Measure the inflammation present in the sinus
Timepoint [2] 330530 0
The levels of different biomarkers that are known to be associated with inflammation (cytokine levels) will be measured in the biopsy tissue samples to determine the extent of inflammation in the sinus. The following inflammation biomarkers will be assessed: the monocyte chemoattractant protein-1 (MCP-1) interleukin-8 (IL-8), the monotone induced by interferon-gamma (MIG), interleukin-15, (IL-15), epidermal growth factor (EGF), eotaxin, interferon gamma-induced protein-10 (IP-10), and interleukin-1 receptor antagonist (IL-1RA).

Eligibility
Key inclusion criteria
Group 1: Controls
> 18 years of age
Disease free sinuses as based on examination by an Ear Nose and Throat Doctor on the same day as the swabs are taken.

Group 2: Cases
>18 years of age
The cases have had a current diagnosis of chronic rhino sinusitis by an Ear Nose and Throat (ENT) Doctor. Specifically, the same day that the samples are being taken from the participant, the participant undergoes an examination by the ENT doctor. Please note that during this examination, the ENT doctor can distinguish chronic rhino sinusitis from acute rhino sinusitis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
< 18 years of age

Group 1: Diseased sinuses

Group 2: Does not have chronic sinusitis

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
A subset of clinical variables will be compared by chi-square or student t-test to look for significant differences.

Microbiology: Microbiology techniques will be used to determine the presence or absence of different bacterial species present in the swabs taken from different parts of the nose, mouth and throat in both cases and controls. The anova and proportion of all cases containing a particular bacterial strain will be compared to this same proportion in controls. Other comparisons will be made as well using the proportion of different bacterial strains in different subsets of the data such as comparing the proportion of males carrying a particular bacterial strain with females carrying that strain, comparing the bacteria found in the mouth with the nose and the throat, comparing the bacteria found in the different locations of the nose.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/04/2015
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
31/12/2017
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7095 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 14851 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 295149 0
University
Name [1] 295149 0
University of Queensland
Country [1] 295149 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia Qld 4072
Country
Australia
Secondary sponsor category [1] 293968 0
None
Name [1] 293968 0
Address [1] 293968 0
Country [1] 293968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296496 0
Royal Brisbane and Women's Health Human Research Ethics Committee
Ethics committee address [1] 296496 0
RBWH HREC
HREC Office, Level 7, Block 7 RBWH
RGO Office, Level 4, UQCCR, RBWH
Butterfield Street, Herston Qld 4029
Ethics committee country [1] 296496 0
Australia
Date submitted for ethics approval [1] 296496 0
30/06/2014
Approval date [1] 296496 0
17/10/2014
Ethics approval number [1] 296496 0
HREC/14/QRBW/274
Ethics committee name [2] 296497 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 296497 0
The University of Queensland Human Research Ethics Committee
UQ Research and Innovation
Cumbrae-Stuart Building / Building #72
Research Road
St Lucia Qld 4072
Ethics committee country [2] 296497 0
Australia
Date submitted for ethics approval [2] 296497 0
10/01/2015
Approval date [2] 296497 0
02/02/2015
Ethics approval number [2] 296497 0
2015000125

Summary
Brief summary
The study aims to determine which bacteria, fungi, and viruses normally exist in the health sinus and chronic rhinosinusitis. Persons with healthy sinuses will be invited to participate in the study (Group 1) as well as individuals with chronic rhinosinusitis (group 2). A number of swabs will be taken from the sinuses of participants as well as a biopsy of the anterior aspect of the middle turbinate for sinus patients and analysed by laboratory techniques (microbiology and immunology).








Trial website
Nil
Trial related presentations / publications
Conference presentations that have resulted from this observational study

1. Sidjabat, H.E., Cottrell, K., Flohr, G., Kitipornchai, L., Hawarden, B., Cervin, A. 2016. Diverse bacterial species in the microbiome of upper respiratory tract of patients with chronic rhinosinusitis and healthy participants. 2016. Abstract No 359, Australian Society for Microbiology Annual Scientific Meeting, Perth, Australia, 3-6 July 2016.

2. Sidjabat, H.E., Cottrell, K., Flohr, G., Morcom, S., Cervin, A. 2015. Characterisation of upper respiratory tract microbiota of patients with chronic rhinosinusitis and healthy participants. Society for Microbial Ecology and Diseases. Verona, Italy, 11-13 October 2015.

Peer reviewed publications that have resulted from this observational study
1. Phillips, N.M., Cervin, A., Ernshaw, J., Sidjabat, H.E. 2016. Melioidosis in a patient with chronic rhinosinusitis. J Laryngol. Jul. 130 Suppl 4:S60-2.
2. Sidjabat, H.E., Cottrell, K and Cervin, A. 2015. Case and draft genome sequences of Burkholderia pseudomallei and Staphylococcus aureus in a chronic rhinosinusitis patient. Genome Announcements. Oct 1;3(5).pii: e01075-15.
Public notes

Contacts
Principal investigator
Name 71022 0
Prof Anders Cervin
Address 71022 0
UQ Centre for Clinical Research
Faculty of Medicine
Level 5, Building 71/918, Royal Brisbane and Women’s Hospital
Butterfield Street
Herston QLD 4029
Country 71022 0
Australia
Phone 71022 0
+61 07 3346 5156
Fax 71022 0
Email 71022 0
a.cervin@uq.edu.au
Contact person for public queries
Name 71023 0
Dr Hanna Sidjabat
Address 71023 0
UQ Centre for Clinical Research
Faculty of Medicine
Level 5, Building 71/918, Royal Brisbane and Women’s Hospital
Butterfield Steet
Herston QLD 4029
Country 71023 0
Australia
Phone 71023 0
+61 7 3346 6073
Fax 71023 0
Email 71023 0
h.sidjabat@uq.edu.au
Contact person for scientific queries
Name 71024 0
Prof Anders Cervin
Address 71024 0
UQ Centre for Clinical Research
Faculty of Medicine
Level 5, Building 71/918, Royal Brisbane and Women’s Hospital
Butterfield Street
Herston QLD 4029
Country 71024 0
Australia
Phone 71024 0
+61 7 3346 6073
Fax 71024 0
Email 71024 0
a.cervin@uq.edu.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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