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CTRI Number  CTRI/2011/08/001971 [Registered on: 29/08/2011] Trial Registered Prospectively
Last Modified On: 23/01/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two skin antibiotic preparations, Mupirocin and Medihoney applied at the catheter exit site of peritoneal dialysis patients 
Scientific Title of Study   A Randomized controlled trial comparing Topical use of Mupirocin versus Medihoney for the prevention of Infection at Tenckhoff Exit Site in Peritoneal Dialysis Patients 
Trial Acronym  TUMMIE 
Secondary IDs if Any  
Secondary ID  Identifier 
ACTRN12611000297921  ANZCTR 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Santosh Varughese 
Designation  Associate Professor 
Affiliation  Christian Medical College 
Address  Department of Nephrology Christian Medical College Ida Scudder Road Vellore- 632004 India

Vellore
TAMIL NADU
632004
India 
Phone  91-04162282053  
Fax  91-416-2232035  
Email  santosh@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Santosh Varughese 
Designation  Associate Professor 
Affiliation  Christian Medical College 
Address  Department of Nephrology Christian Medical College Ida Scudder Road Vellore 632004 Tamil Nadu India

Vellore
TAMIL NADU
632004
India 
Phone  0416-2282053  
Fax  0416-2232035  
Email  santosh@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Santosh Varughese 
Designation  Associate Professor 
Affiliation  Christian Medical College 
Address  Department of Nephrology Christian Medical College Ida Scudder Road Vellore 632004 Tamil Nadu India

Vellore
TAMIL NADU
632004
India 
Phone  0416-2282053  
Fax  0416-2232035  
Email  santosh@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Shortlisted for BAXTER 2011 Renal Discoveries Extramural Grant Program 
 
Primary Sponsor  
Name  Royal Brisbane Hospital Queensland Australia 
Address  Department of Renal Medicine Royal Brisbane Hospital/ School of Medicine, UQ L9, Ned Hanlon Building Herston, Queensland Postal Code-4029 Australia  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
China
India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Santosh Varughese  Christian Medical College  Department of Nephrology, Christian Medical College,Ida Scudder Road, Vellore, Tamil Nadu 632004, India
Vellore
TAMIL NADU 
91-416-2282053
91-416-2232035
santosh@cmcvellore.ac.in 
Vivekanand Jha  Postgraduate Institute of Medical Education and Research  Department of Nephrology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India
Chandigarh
CHANDIGARH 
91-172-2755213
91-172-2740282
vjha@pginephro.org 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh  Approved 
Institutional Review Board (Ethics Committee), Christian Medical College, Vellore 632004, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Prevention of Infection at Tenckhoff Exit Site in Peritoneal Dialysis Patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active Control- 2% Mupirocin   Active Control-2% Mupirocin will be self-administered daily topically to the exit site of PD catheter 
Intervention  Intervention- Pooled Antibacterial Honeys (Medihoney-Comvita)   Intervention Arm- Gamma irradiated, commercially available, pooled antibacterial honeys, including Leptospermum sp honey (Medihoney-Comvita, approximately 10 mg) will be self-administered daily topically to the exit site of PD catheter.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  • Chronic Kidney Disease stage 5 patients aged 18 years or older on PD
• Incident and prevalent PD patients willing to provide informed consent
 
 
ExclusionCriteria 
Details  • History of psychological illness or condition that interferes with ability to understand or comply with the requirements of the study;
• Recent (within 1 month) ESI, peritonitis, or tunnel infection;
• Known hypersensitivity to, or intolerance of, honey or mupirocin;
• Current or recent (within 4 weeks) treatment with an antibiotic administered by any route
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure will be time to first episode of ESI, tunnel infection, or peritonitis, whichever comes first.   Time to first episode of ESI, tunnel infection, or peritonitis, whichever comes first.  
 
Secondary Outcome  
Outcome  TimePoints 
• Time to first episode of peritonitis  • Time to first episode of peritonitis 
• Time to first tunnel infection  • Time to first tunnel infection 
• Time to first ESI within the study period  • Time to first ESI within the study period 
• Time to infection-associated catheter removal  • Time to infection-associated catheter removal 
• Catheter-associated infection rates, including subgroup analyses according to causative organisms  End of study 3 years 
• Occurrence of mupirocin-resistant microbial isolates; (with respect to System organ class  End of study 3 years 
• Incidence of adverse reactions  End of Study 3 years 
• Costs. ( cost of Mupirocin/Medihoney, cost of antibiotic usage in the event of infections, cost of hospitalisation related to PD related infections)  End of Study 3 years 
 
Target Sample Size   Total Sample Size="440"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/09/2011 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/09/2011 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The investigators subscribe to the criteria for authorship formulated by the International Committee of Medical Journal Editors. The principal investigator and the investigator who made substantial contribution will occupy the first and the last positions on the paper which reports the main results of the trial. They are responsible for determining the order of other authors. Publication Details- None yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The most important complications of long-term peritoneal dialysis (PD) are peritonitis and exit site infections (ESI) as both can result in catheter loss and technique failure . ESI are associated with six-fold risk of peritonitis, catheter loss and considerable morbidity.  Simultaneous ESI and peritonitis results in catheter removal in half the cases. Interest has been focussed on decolonisation of patients with these organisms.  Many studies using mupirocin, gentamicin, neomyci, and rifampicin in varying combinations of oral, topical or intranasal application have been done to examine use of antimicrobials to combat ESI’s and reduce peritonitis and catheter removal.

There are no strong recommendations in the international guidelines. There is need of alternative chemoprophylaxis as mupirocin is active against gram-positive organisms and gentamicin is mainly active against gram-negative organisms. Honey is an antimicrobial agent against a broad spectrum of organisms such as methicillin-resistant S. aureus, multidrug-resistant gram-negative organisms, and vancomycin-resistant enterococci and fungi.  Honey (Medihoney, Comvita, New Zealand), is active against all organisms and with no reported resistance so far, is used at the exit site of central venous (CV) catheters. With the success of using Medihoney at the exit site of CV catheters, we propose therefore to conduct a study comparing topical medihoney at the exit site with topical mupirocin irrespective of the S.aureus carrier status of the patient.

 

 
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