Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000994987
Ethics application status
Approved
Date submitted
19/09/2011
Date registered
19/09/2011
Date last updated
19/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Mupirocin in patients with refractory chronic rhinosinusitis - A prospective, randomised double-blinded controlled trial
Scientific title
Effect of Mupirocin on S.aureus infection in patients with refractory chronic rhinosinusitis - A prospective, randomised double-blinded controlled trial
Secondary ID [1] 263059 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis 270794 0
Condition category
Condition code
Infection 270982 270982 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mupirocin nasal rinses, 0.05% twice daily for 4 weeks.
Intervention code [1] 269408 0
Treatment: Drugs
Comparator / control treatment
Placebo (saline rinses)
Control group
Placebo

Outcomes
Primary outcome [1] 279651 0
S.aureus infection, as assessed by endoscopically-guided nasal swab
Timepoint [1] 279651 0
At end of 4-week treatment
Secondary outcome [1] 294126 0
Signs and symptoms of chronic rhinosinusitis, as assessed by the sinonasal outcome test (SNOT-20) and the Lund-Kennedy endoscopic examination score.
Timepoint [1] 294126 0
At end of 4-week treatment

Eligibility
Key inclusion criteria
Patients with surgically-recalcitrant, S.aureus-positive chronic rhinosinusitis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mupirocin allergy.
Augmentin Duo allergy.
Multiple bacterial species on culture.
MRSA.
Mupirocin-resistant S.aureus.

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?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269881 0
Hospital
Name [1] 269881 0
Department of Otolaryngology Head & Neck Surgery
Country [1] 269881 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
28 Woodville Road, Woodville South, South Australia
5011
Country
Australia
Secondary sponsor category [1] 268897 0
None
Name [1] 268897 0
Address [1] 268897 0
Country [1] 268897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271850 0
Ethics of Human Research Committe (TQEH & LMH)
Ethics committee address [1] 271850 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA 5011
Ethics committee country [1] 271850 0
Australia
Date submitted for ethics approval [1] 271850 0
Approval date [1] 271850 0
16/06/2009
Ethics approval number [1] 271850 0
2008171

Summary
Brief summary
We hypothesise that Mupirocin nasal rinses are more efficacious compared to placebo in patients that are bothered by persistent S.aureus infection despite complete sinus surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33171 0
Address 33171 0
Country 33171 0
Phone 33171 0
Fax 33171 0
Email 33171 0
Contact person for public queries
Name 16418 0
Josh Jervis-Bardy
Address 16418 0
Department of Otolaryngology Head & Neck Surgery
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country 16418 0
Australia
Phone 16418 0
+61 8 82226000
Fax 16418 0
+61 8 82227419
Email 16418 0
josh.bardy@hotmail.com
Contact person for scientific queries
Name 7346 0
Josh Jervis-Bardy
Address 7346 0
Department of Otolaryngology Head & Neck Surgery
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
South Australia 5011
Country 7346 0
Australia
Phone 7346 0
+61 8 82226000
Fax 7346 0
+61 8 82227419
Email 7346 0
josh.bardy@hotmail.com

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.