Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy

NCT ID: NCT01237730

Last Updated: 2010-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-08-31

Brief Summary

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

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.

Conditions

The Patients Who Receive Percutaneous Endoscopic Gastrostomy; Peristomal Wound Infection After the Operation of PEG; Prophylactic Antibiotics Before PEG

Keywords

percutaneous endoscopic gastrostomy; peristomal wound infection; prophylactic antibiotics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cefuroxime group

Use the cefuroxime as prophylactic antiobiotics, according to the clinical guideline.

Group Type: ACTIVE_COMPARATOR

cefuroxime

Intervention Type: DRUG

Use the cefuroxime as prophylaxis.

Tailored antibiotics group

Tailored antibiotic is selected according to the patient's oropharyngeal microorganisms.

Group Type: EXPERIMENTAL

Tailored antibiotic

Intervention Type: DRUG

Select the prophylactic antibiotics according to the patients oropharyngeal microorganism.

Interventions

cefuroxime

Use the cefuroxime as prophylaxis.

Intervention Type: DRUG

Tailored antibiotic

Select the prophylactic antibiotics according to the patients oropharyngeal microorganism.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng Kung University

OTHER

Sponsor Role: lead

Responsible Party

National cheng kung univeristy

Principal Investigators

chiao-hsiung chuang, M.D.

Role: STUDY_DIRECTOR

National Cheng-Kung University Hospital

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

chiao-hsiung chuang, M.D.

Role: CONTACT

Phone: 88662353535

Email: chuang.chiaohsiung@gmail.com

Facility Contacts

chiaohsiung chuang, M.D.

Role: primary

Other Identifiers

NCKU-HR99

Identifier Type: -

Identifier Source: org_study_id