Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000297921
Ethics application status
Approved
Date submitted
15/03/2011
Date registered
21/03/2011
Date last updated
25/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomized controlled trial comparing Topical use of Mupirocin versus Medihoney for the prevention of infection at Tenckhoff Exit Site in Peritoneal Dialysis Patients
Scientific title
A Randomized controlled trial comparing Topical use of Mupirocin versus Medihoney for the prevention of infection at Tenckhoff Exit Site in Peritoneal Dialysis Patients
Secondary ID [1] 259802 0
NIl
Universal Trial Number (UTN)
N/A
Trial acronym
TUMMIE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritineal Dialysis patients 261370 0
Condition category
Condition code
Renal and Urogenital 259489 259489 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once daly application of Topical Medihoney (gauze pad) approximately10 mg ( size of a pea) at Peritoneal dialysis catheter exit site once daily (the medihoney dressing will be changed daily ) compared topical application of small amount Mupirocin using cotton bud to Peritoneal dialysis catheter exit site once daily ( 12 months )
Intervention code [1] 264218 0
Treatment: Drugs
Comparator / control treatment
Medihoney (Intervention ) vs Mupirocin ( control)
Control group
Active

Outcomes
Primary outcome [1] 262335 0
time to first episode of exit site infection,peritonitis or tunnel infection -whichever comes first ( clinical assessment and microbiolgy to confirm the infection)
Timepoint [1] 262335 0
12 months
Secondary outcome [1] 273554 0
Secondary Endpoints : whether intervention results in:
a longer time to first exit site infection ( clinical assessment / microbiology)
Timepoint [1] 273554 0
12 months
Secondary outcome [2] 273555 0
whether intervention results in a longer time first episode of peritonitis (clinical assessment / microbiology)
Timepoint [2] 273555 0
12 months
Secondary outcome [3] 273560 0
a longer time to infection-associated catheter removal
lower catheter-associated infection rates;
Meausred by number of catheter removal due to infection
Timepoint [3] 273560 0
12 months
Secondary outcome [4] 273589 0
a lower incidence of adverse reactions ( all adverse events will be recorded and compared between the 2 groups).
Methods used will be questionarre and occurence of resistance ( Microbiology test)
Timepoint [4] 273589 0
12 months

Eligibility
Key inclusion criteria
1. Patients on peritoneal dialysis.( Incident and prevalent)
2. Able to give informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. PD patients who had exit site infection, peritonitis, or tunnel infection within the last 4 weeks
2. Known hypersensitivity to, or intolerance of, honey or mupirocin.
3. On long term antibiotics for any reason.
4. Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study.

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of patients into the two groups will be based on computer generated numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Safety and efficay of Medihoney vs Mupirocin
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
380
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264666 0
Hospital
Name [1] 264666 0
Department of Renal Medicine
Country [1] 264666 0
Australia
Funding source category [2] 264667 0
Commercial sector/Industry
Name [2] 264667 0
Comvita NewZealand Limited
Country [2] 264667 0
New Zealand
Primary sponsor type
Hospital
Name
Department of Renal Medicine
Address
Royal brisbane & Women's Hospitals
Butterfield Street,
Herston, Qld, 4029
Country
Australia
Secondary sponsor category [1] 263804 0
Commercial sector/Industry
Name [1] 263804 0
Comvita NewZealand Limited
Address [1] 263804 0
Private Bag 1, Te Puke
Phone : 64 -0800 504 959 ( No post code
Country [1] 263804 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266662 0
Human Reseearch and ethics Committee
Ethics committee address [1] 266662 0
Royal Brisbane &Woen's hospitals
Herston, Qld, 4029
Ethics committee country [1] 266662 0
Australia
Date submitted for ethics approval [1] 266662 0
26/10/2010
Approval date [1] 266662 0
24/01/2011
Ethics approval number [1] 266662 0
HREC/10/QRBW?422

Summary
Brief summary
not recruiting
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32326 0
Address 32326 0
Country 32326 0
Phone 32326 0
Fax 32326 0
Email 32326 0
Contact person for public queries
Name 15573 0
Dwarakanathan Ranganathan
Address 15573 0
Department of Renal Medicine,
Butterfield Street,
Royal Brisbane & women's Hospitals
Herston, Qld, 4029
Country 15573 0
Australia
Phone 15573 0
61-7-36368576
Fax 15573 0
61-7-36368572
Email 15573 0
[email protected]
Contact person for scientific queries
Name 6501 0
Dwarakanathan Ranganathan
Address 6501 0
Department of Renal Medicine,
Butterfield Street,
Royal Brisbane & women's Hospitals
Herston, Qld, 4029
Country 6501 0
Australia
Phone 6501 0
61-7-36368576
Fax 6501 0
61-7-36368572
Email 6501 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.