跳至主要内容
临床试验/CTRI/2011/08/001971
CTRI/2011/08/001971尚未招募2/3 期

A Randomized controlled trial comparing Topical use of Mupirocin versus Medihoney for the prevention of Infection at Tenckhoff Exit Site in Peritoneal Dialysis Patients

Royal Brisbane Hospital Queensland Australia2 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2011年9月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
440
试验地点
2
主要终点
The primary outcome measure will be time to first episode of ESI, tunnel infection, or peritonitis, whichever comes first.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Chronic Kidney Disease stage 5 patients aged 18 years or older on PD •Incident and prevalent PD patients willing to provide informed consent.

排除标准

  • 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.

结局指标

主要结局

The primary outcome measure will be time to first episode of ESI, tunnel infection, or peritonitis, whichever comes first.

时间窗: Time to first episode of ESI, tunnel infection, or peritonitis, whichever comes first.

次要结局

  • •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)

研究者

发起方
Royal Brisbane Hospital Queensland Australia
申办方类型
Research institution and hospital

研究点 (2)

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