The Patients Who Receive Percutaneous Endoscopic GastrostomyPEGNCT01237730
Tailored Antibiotics Prophylaxis for Percutaneous Endoscopic Gastrostomy
A study testing cefuroxime and Tailored antibiotic in people with The Patients Who Receive Percutaneous Endoscopic Gastrostomy and Peristomal Wound Infection After the Operation of PEG, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce the peristomal infection rate Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- The Patients Who Receive Percutaneous Endoscopic Gastrostomy, Peristomal Wound Infection After the Operation of PEG, Prophylactic Antibiotics Before PEG
- What is being tested?
- cefuroxime and Tailored antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who receive PEG by pull method in our hospital, a tertiary transferring center, will be included
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
chiaohsiung chuang, M.D., 88662353535 ext. 2679, chuang.chiaohsiung@gmail.com
chiao-hsiung chuang, M.D.
About this study
Official title: 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
Read the 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:
- 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.
- 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:
- If individual tailored antibiotic prophylaxis according to throat swab could reduce the peristomal infection rate?
- If the phenotype and genotype analysis were compatible between infected wound isolates and throat swab/sputum isolates?
- If throat swab culture is better than sputum culture to predict peristomal infected microorganism?
- Is the infection is also linked to the oropharyngeal isolates if the patients get peristomal infection more than one week after PEG?
Anticipated results:
- Individual tailored antibiotic prophylaxis according to the throat swab culture could reduce the peristomal infection rate of PEG and short the days of hospitalization.
- 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.
- 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.
- 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
- Being tested
- cefuroxime, Tailored antibiotic
- Keywords
- percutaneous endoscopic gastrostomy, peristomal wound infection, prophylactic antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefuroximeDrug
Use the cefuroxime as prophylaxis.
Tailored antibioticDrug
Select the prophylactic antibiotics according to the patients oropharyngeal microorganism.
| Study group | Role | What they receive |
|---|---|---|
| Cefuroxime group | Active comparator | Use the cefuroxime as prophylactic antiobiotics, according to the clinical guideline. Receives: Drug: cefuroxime |
| Tailored antibiotics group | Experimental | Tailored antibiotic is selected according to the patient's oropharyngeal microorganisms. Receives: Drug: Tailored antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peristomal wound infection
Measured: Two weeks after operation of PEG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Patients Who Receive Percutaneous Endoscopic GastrostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Investigators
- chiao-hsiung chuang, M.D., Study director, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237730
- Sponsor's protocol ID
- NCKU-HR99
- Acronym
- PEG
- Status last verified
- Jul 2010
- First submitted
- 9 Nov 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oropharyngeal Microorganism Colonization on the Peristomal Infection After Percutaneous Endoscopic Gastrostomy and the Effect of Tailored Antibiotics Prophylaxis
- ClinicalTrials.gov ID
- NCT01237730
- Acronym / sponsor ID
- PEG / NCKU-HR99
- 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 type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- If individual tailored antibiotic prophylaxis according to throat swab could reduce the peristomal infection rate?
- If the phenotype and genotype analysis were compatible between infected wound isolates and throat swab/sputum isolates?
- If throat swab culture is better than sputum culture to predict peristomal infected microorganism?
- Is the infection is also linked to the oropharyngeal isolates if the patients get peristomal infection more than one week after PEG?
Anticipated results:
- Individual tailored antibiotic prophylaxis according to the throat swab culture could reduce the peristomal infection rate of PEG and short the days of hospitalization.
- 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.
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefuroxime group | Active comparator | Drug: cefuroximeUse the cefuroxime as prophylactic antiobiotics, according to the clinical guideline. |
| Tailored antibiotics group | Experimental | Drug: Tailored antibioticTailored antibiotic is selected according to the patient's oropharyngeal microorganisms. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who receive PEG by pull method in our hospital, a tertiary transferring center, will be included
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cefuroximeUse the cefuroxime as prophylaxis. | Drug | Cefuroxime group |
| Tailored antibioticSelect the prophylactic antibiotics according to the patients oropharyngeal microorganism. | Drug | Tailored antibiotics group |
Primary outcome
Peristomal wound infection
Time frame: Two weeks after operation of PEG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
chiao-hsiung chuang, M.D. study director
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cefuroxime and Tailored antibiotic in people with The Patients Who Receive Percutaneous Endoscopic Gastrostomy and Peristomal Wound Infection After the Operation of PEG, run by National Cheng Kung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chiao-hsiung chuang, M.D. (88662353535 ext. 2679, chuang.chiaohsiung@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peristomal wound infection (time frame: Two weeks after operation of PEG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2010.