Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01237730 |
| Other study ID # |
NCKU-HR99 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
November 9, 2010 |
| Last updated |
November 9, 2010 |
| Start date |
July 2010 |
| Est. completion date |
August 2011 |
Study information
| Verified date |
July 2010 |
| Source |
National Cheng Kung University |
| Contact |
chiao-hsiung chuang, M.D. |
| Phone |
88662353535 |
| Email |
chuang.chiaohsiung[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
Taiwan: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
Tailored antibiotic prophylaxis according to the individual throat swab culture could reduce
the peristomal infection rate
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.
