Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG)

November 9, 2010 updated by: National Cheng Kung University

Impact of Oropharyngeal Microorganism Colonization on the Peristomal Infection After Percutaneous Endoscopic Gastrostomy and the Effect of Tailored Antibiotics Prophylaxis

Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce the peristomal infection rate

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Past know-how:

Antibiotic prophylaxis has been shown to be effective to reduce peristomal infection.[9-11] The penicillin-or cephalosporin-based antibiotic prophylaxis are usually used with similar efficacy.[12] EuropeanSociety of Gastrointestinal Endoscopy (ESGE) guideline recommend that a single dose of intravenous cephalosporin orpenicillin as preparation before PEG.[17] The updated practice guidelines of American Society for Gastrointestinal Endoscopy (ASGE) and British Society of Gastroenterology (BSG) also recommend cefazolin or cefuroxime as prophylactic antibiotics.[18-19]

Question:

Is the 1st or 2nd generation cephalosporin is adequate as prophylactic antibiotics for percutaneous endoscopic gastrostomy (PEG)?

Preliminary results:

  1. The leading two common pathogen to cause peristomal infection of PEG are P. aeuroginosa and methecillin-resistanced S. aurous. (Figure 1) These two common pathogen can't be covered by the prophylactic antibiotics which suggested by guideline.
  2. The patient with airway infection before PEG had higher peristomal infection rate, comparing with those without airway infection. Moreover, adequate antibiotics prophylaxis could significant improve the infection rate. (Table 1)

Hypothesis:

Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce the peristomal infection rate.

Specific aims:

  1. If individual tailored antibiotic prophylaxis according to throat swab could reduce the peristomal infection rate?
  2. If the phenotype and genotype analysis were compatible between infected wound isolates and throat swab/sputum isolates?
  3. If throat swab culture is better than sputum culture to predict peristomal infected microorganism?
  4. Is the infection is also linked to the oropharyngeal isolates if the patients get peristomal infection more than one week after PEG?

Anticipated results:

  1. Individual tailored antibiotic prophylaxis according to the throat swab culture could reduce the peristomal infection rate of PEG and short the days of hospitalization.
  2. Most phenotype and genotype are compatible between peristomal isolates and throat swab/sputum isolates. It indicates that most pathogens are carried from throat into the peristomal to cause the infection. The microorganism isolated from throat swab could predict the pathogen of PEG peristomal infection.
  3. The throat swab culture may be better than sputum culture to predict the peristomal infected pathogen because some unconscious patients is difficult to collect sputum.
  4. Peristomal infection more than one week after PEG may be not associated to throat pathogen. It may be related to the contamination during wound care.

Significances:

This proposal result could be applied to clinical care of percutaneous endoscopic gastrostomy. The individual chose of prophylactic antibiotics could improve the peristomal infection rate. Currently, 1st or 2nd cephalosporin was usually recommended as prophylaxis before PEG. However, for the patient with ORSA culture from nasal cavity, vancomycin was suggested as prophylaxis because some studies support the benefit on infection prevention. If the results are positive, it may change the clinical guideline on antibiotics prophylaxis before PEG.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
        • Principal Investigator:
          • chiao-hsiung chuang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients who receive PEG by pull method in our hospital, a tertiary transferring center, will be included

Exclusion Criteria:

  • The exclusion criteria for entry are inability to place the gastrostomy for technical reasons, such as oropharyngeal deformity or esophageal stricture. The patients who receive PEG by percutaneous push method will be excluded. The patients will be also excluded if active infection and fever are identified, and the PEG is delayed until the infection is brought under control.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cefuroxime group
Use the cefuroxime as prophylactic antiobiotics, according to the clinical guideline.
Drug: cefuroxime
Use the cefuroxime as prophylaxis.
Experimental: Tailored antibiotics group
Tailored antibiotic is selected according to the patient's oropharyngeal microorganisms.
Drug: Tailored antibiotic
Select the prophylactic antibiotics according to the patients oropharyngeal microorganism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peristomal wound infection
Time Frame: Two weeks after operation of PEG
Two weeks after operation of PEG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng Kung University

Investigators

  • Study Director: chiao-hsiung chuang, M.D., National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Estimate)

November 10, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCKU-HR99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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