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
- Conditions
- Prevention of Infection at Tenckhoff Exit Site in Peritoneal Dialysis Patients
- Registration Number
- CTRI/2011/08/001971
- Lead Sponsor
- Royal Brisbane Hospital Queensland Australia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 440
•Chronic Kidney Disease stage 5 patients aged 18 years or older on PD •Incident and prevalent PD patients willing to provide informed consent.
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method •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 •Time to first episode of peritonitis •Time to first episode of peritonitis •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
Trial Locations
- Locations (2)
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Postgraduate Institute of Medical Education and Research
🇮🇳Chandigarh, CHANDIGARH, India
Christian Medical College🇮🇳Vellore, TAMIL NADU, IndiaSantosh VarughesePrincipal investigatorsantosh@cmcvellore.ac.in