Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000169549
Ethics application status
Approved
Date submitted
4/02/2015
Date registered
20/02/2015
Date last updated
1/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of antibiotics and oral steroids on patients with chronic sinusitis
Scientific title
The effect of doxycycline and prednisone on the microbiome of patients with chronic sinusitis, a study by the Department of Surgery, University of Auckland.
Secondary ID [1] 286100 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CHRONIC SINUSITIS 294101 0
Condition category
Condition code
Inflammatory and Immune System 294412 294412 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilot RCT - 20 patients who have not previously been diagnosed with CRS and are on the waiting list for endoscopic sinus surgery, but have not yet undergone surgery. Patients will not undergo surgery during the study period. Patients will have not had antibiotics or oral steroids for at least 4 weeks.

To assess the effect of doxycycline and prednisone on the microbiome of patients with chronic rhinosinusitis. Patients will be swabbed before and after therapy. Drug monitoring will be by patient recorded journal and drug tablet return.

Arm1
100mg doxycycline orally, twice daily for one week.

Arm2
30mg prednisone orally, once daily for one week.
Intervention code [1] 291093 0
Treatment: Drugs
Comparator / control treatment
As swabs are taken before and after therapy, each patient will serve as their own control. Doxycycline will be considered to be the comparator treatment.
Control group
Active

Outcomes
Primary outcome [1] 294205 0
Microbiology swabs are taken from CRS patients attending the specialist rhinology clinics. Laboratory analysis of the swabs will be undertaken before and after medical therapy and will be compared. The primary endpoint is mucous microbiology.
Timepoint [1] 294205 0
Swabs before and after one week of therapy.
Secondary outcome [1] 312766 0
Nil
Timepoint [1] 312766 0
Nil

Eligibility
Key inclusion criteria
Patients newly diagnosed with CRS and are eligible for sinus surgery.
Patients providing fully informed consent to participate in this study.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are acutely unwell.
Patients with cystic fibrosis.
Patients with a history of previous nasal surgery.
Children (<16 years)
Immunodeficiency (congenital or acquired)
Congenital mucociliary problems (e.g. primary ciliary dyskinesia)
Non-invasive and invasive fungal sinus disease
Systemic vasculitis and granulomatous diseases
History of cocaine abuse;
Patients requiring sinus surgery for neoplasia
Patients unable to consent (e.g. lack of mental capacity)

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)
Central randomisation by computer database
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation by computer database
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
As the effect size for these interventions is not known, this study serves as a pilot RCT.

Analysis of variance for changes within an individual following treatment and differences of means within groups will be assessed. Alpha and beta diversity of microbial communities will be analysed. Statistical significance will be accepted at the 0.05 level.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/02/2015
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] 6626 0
New Zealand
State/province [1] 6626 0

Funding & Sponsors
Funding source category [1] 290680 0
Self funded/Unfunded
Name [1] 290680 0
N/A
Country [1] 290680 0
Primary sponsor type
Individual
Name
Associate Professor Richard Douglas
Address
Department of Surgery
The University of Auckland
Level 12, Room 12-087, ACH Support Building, Park Road, Grafton. 1142.
Country
New Zealand
Secondary sponsor category [1] 289374 0
Individual
Name [1] 289374 0
Dr Ravi Jain
Address [1] 289374 0
Department of Surgery
The University of Auckland
Level 12, Room 12-087, ACH Support Building, Park Road, Grafton. 1142.
Country [1] 289374 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292311 0
New Zealand HDEC
Ethics committee address [1] 292311 0
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013 Wellington. 6011
Ethics committee country [1] 292311 0
New Zealand
Date submitted for ethics approval [1] 292311 0
Approval date [1] 292311 0
15/09/2014
Ethics approval number [1] 292311 0
14/NTA/134

Summary
Brief summary
The aim of this pilot study is to investigate and compare the microbiological effects of two types of medications which are used routinely by patients with chronic rhinosinusitis (antibiotics and oral steroids). In current practice around the world both drugs are commonly used either separately or together, however the effect of each drug on the complex microbial communities is not known.

We anticipate that better understandings of the effect of our current medical management on the microbiome will help us in the future to develop and deliver more targeted therapy to our patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54634 0
A/Prof Richard Douglas
Address 54634 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 54634 0
New Zealand
Phone 54634 0
+64 27 2186083
Fax 54634 0
Email 54634 0
richard.douglas@auckland.ac.nz
Contact person for public queries
Name 54635 0
Dr Ravi Jain
Address 54635 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 54635 0
New Zealand
Phone 54635 0
+64 21 728452
Fax 54635 0
Email 54635 0
ravi.jain@auckland.ac.nz
Contact person for scientific queries
Name 54636 0
Dr Ravi Jain
Address 54636 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 54636 0
New Zealand
Phone 54636 0
+64 21 728452
Fax 54636 0
Email 54636 0
ravi.jain@auckland.ac.nz

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.