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Trial registered on ANZCTR


Registration number
ACTRN12621000674831
Ethics application status
Approved
Date submitted
20/04/2021
Date registered
3/06/2021
Date last updated
29/04/2024
Date data sharing statement initially provided
3/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Doxycycline after sinus surgery
Scientific title
A multi-centre randomised controlled trial of post-operative doxycycline assessing recovery in patients undergoing endoscopic sinus surgery for the treatment of chronic rhinosinusitis
Secondary ID [1] 304006 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-up study to a prior pilot study:
Australia and New Zealand Clinical Trials Register Reference number ACTRN12619000505101p
Universal Trial Number U1111-1229-8735

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 321626 0
Condition category
Condition code
Surgery 319367 319367 0 0
Other surgery
Respiratory 319368 319368 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Doxycycline 100mg tablets by mouth twice daily for 2 weeks, commencing on the morning after surgery. Patients will be asked to return any unused tablets to monitor adherence.
Intervention code [1] 320316 0
Treatment: Drugs
Comparator / control treatment
Microcellulose placebo tablet by mouth twice daily for 4 weeks starting on the morning after surgery
Control group
Placebo

Outcomes
Primary outcome [1] 327227 0
22-item Sino Nasal Outcome Tool (SNOT-22) score
Timepoint [1] 327227 0
3 months post-operative
Secondary outcome [1] 394289 0
22-item Sino Nasal Outcome Tool (SNOT-22) score
Timepoint [1] 394289 0
2 weeks and 12 months post-operative
Secondary outcome [2] 394290 0
Modified Lund Mckay Postoperative Endoscopy Score (MLMES) Reference: Snidvongs et al. Rhinology. 2013
Timepoint [2] 394290 0
3 months post-operative
Secondary outcome [3] 394291 0
Change in sinus mucus microbial ecology assessing the resident microflora of sinus mucus using PCR to amplify microbial DNA
Timepoint [3] 394291 0
Intra-operative and at 2 weeks and 3 months post-operative
Secondary outcome [4] 394293 0
Patient reported adverse events including but not limited to rash, diarrhoea, vomiting, abdominal pain via documentation of verbal feedback
Timepoint [4] 394293 0
Entire time course over which study drug and placebo are administered
Secondary outcome [5] 395946 0
Cytokine levels in sinus mucus via swab collection and assay
Timepoint [5] 395946 0
Intra-operative and at 2 weeks and 3 months post-operative

Eligibility
Key inclusion criteria
Patient undergoing Bilateral Comprehensive Endoscopic Sinus Surgery for the treatment of chronic rhinosinusitis as defined by the European Position Statement, 2020
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior sinus surgery
Predisposing condition (e.g. Aspirin exacerbated respiratory disease, Granulomatosis with Polyangitis, Cystic fibrosis)
Antibiotic usage in the 4 weeks prior to recruitment.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
Safety/efficacy
Statistical methods / analysis
Power calculations based on pilot study, n=50 provides 99% power

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/03/2023
Actual
25/05/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
50
Accrual to date
36
Final
Recruitment outside Australia
Country [1] 23606 0
New Zealand
State/province [1] 23606 0

Funding & Sponsors
Funding source category [1] 308671 0
Charities/Societies/Foundations
Name [1] 308671 0
Linsell Richards Education Fund administered by the New Zealand Society of Otolaryngology-Head and Neck Society
Country [1] 308671 0
New Zealand
Funding source category [2] 313506 0
Charities/Societies/Foundations
Name [2] 313506 0
Waikato Medical Research Foundation
Country [2] 313506 0
New Zealand
Funding source category [3] 313507 0
Charities/Societies/Foundations
Name [3] 313507 0
Herbert and Gloria Keys Research Scholarship
Country [3] 313507 0
Australia
Primary sponsor type
Individual
Name
Dr. Andrew James Wood
Address
Department of Surgery,
Waikato Clinical School,
Waikato Hospital,
Pembroke Street,
Hamilton 3204
Country
New Zealand
Secondary sponsor category [1] 309216 0
None
Name [1] 309216 0
Not applicable
Address [1] 309216 0
Not applicable
Country [1] 309216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308352 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 308352 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street Thorndon
Wellington 6011
Ethics committee country [1] 308352 0
New Zealand
Date submitted for ethics approval [1] 308352 0
30/06/2021
Approval date [1] 308352 0
19/11/2021
Ethics approval number [1] 308352 0
21/NTA/114

Summary
Brief summary
Endoscopic Sinus Surgery (ESS) is one of the most commonly performed elective surgical procedures in the Western world.
A prior study in 2015 (Valdez et al. Current trends in preoperative antibiotic use: A survey of Otolaryngologists) reported that 73% of ENT Surgeons reported use of peri-operative antibiotics in ESS.
Antibiotic resistance has been described by the World Health Organisation (WHO) as “one of the biggest threats to global health” and is accelerated by misuse of antibiotics. Data to rationalise or discourage the use of antibiotics are therefore urgently required.
The initial aim of the pilot study was to facilitate this larger study to clarify the role of oral antibiotics in this setting. Despite their widespread use in this context, the pilot study has suggested that oral antibiotics may in fact be inferior to placebo in this context.
Ultimately this study therefore has the capacity to either rationalise or prevent the use of many millions of antibiotic scripts across the World and potentially generate improved post-ESS outcomes for patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110414 0
Dr Andrew James Wood
Address 110414 0
Department of Surgery,
Waikato Clinical School,
Waikato Hospital,
Pembroke Street,
Hamilton 3204
Country 110414 0
New Zealand
Phone 110414 0
+64 78398750
Fax 110414 0
Email 110414 0
[email protected]
Contact person for public queries
Name 110415 0
Andrew James Wood
Address 110415 0
Department of Surgery,
Waikato Clinical School,
Waikato Hospital,
Pembroke Street,
Hamilton 3204
Country 110415 0
New Zealand
Phone 110415 0
+64 78398750
Fax 110415 0
Email 110415 0
[email protected]
Contact person for scientific queries
Name 110416 0
Andrew James Wood
Address 110416 0
Department of Surgery,
Waikato Clinical School,
Waikato Hospital,
Pembroke Street,
Hamilton 3204
Country 110416 0
New Zealand
Phone 110416 0
+64 78398750
Fax 110416 0
Email 110416 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Analysed data will be presented in published manuscript(s). De-identified demographics, pre-operative clinical parameters, outcome measures and adverse events will be available on request to Scientific researchers.
When will data be available (start and end dates)?
After completion of the study the intention is to publish the data in the International Scientific literature and present our findings at International Scientific meetings. No specific end date on availability of de-identified data.
Available to whom?
Anyone that accesses the published manuscript(s).
Available for what types of analyses?
Any scientific analysis.
How or where can data be obtained?
Publication in the Scientific literature will provide the analysed data. There will be the option available for Scientific researchers to request de-identified raw data for meta-analyses etc. via email approach to the Principle Investigator: [email protected]


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.