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
|
|
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
|
|
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. |