A Trial Assessing Peri-procedure Chemoprophylaxis During Transrectal Prostate Needle Biopsy
Information source: Mansoura University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostate Hyperplasia
Intervention: ciprofloxacin (Drug); ciprofloxacin and gentamycine (Drug); culture based chemoprophylaxis (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mansoura University Official(s) and/or principal investigator(s): Ahmed M Elshal, MD, Principal Investigator, Affiliation: Mansoura Urology and Nephrology center
Overall contact: ahmed m elshal, MD, Phone: +201001855490, Email: ELSHALAM@HOTMAIL.COM
Summary
The aim of the study is to evaluate whether changing antibiotic prophylaxis from
fluoroquinolones alone to fluoroquinolones plus gentamicin 160mg single IM dose or targeted
antibiotic prophylaxis according to rectal swab culture would influence infectious
complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy.
Clinical Details
Official title: A Randomized Controlled Trial Comparing Rectal Swab Culture Based Chemoprophylaxis Versus Combined Single-Shot Gentamycin and Ciprofloxacin Versus Ciprofloxacin Alone for Peri-procedure Chemoprophylaxis During Transrectal Prostate Biopsy.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: occurrence of post procedure infectious complications
Secondary outcome: flouroquinolones resistance in rectal carriagepost procedure non-infectious complications
Detailed description:
Introduction Transrectal ultrasound (TRUS) guided prostate biopsy is the standard procedure
for the histological diagnosis and grading of prostate cancer that consequently help in
providing the appropriate line of treatment. Risks of infectious complications post
TRUS-guided biopsy have increased in the last years.
In their study, a total of 5798 TRUS-guided biopsies performed between 2002 and 2011.
Increased incidence of infectious complications is noted from 0. 52 infections per 100
biopsies between 2002 and 2009 to 2. 15 infections per 100 biopsies between 2010 and 2011 (P<
0. 001). The commonest organism found to be responsible for these infectious complications is
Escherichia coli (E. Coli).
The American Urological Association best practice policy statement recommends antibiotic
prophylaxis prior to transrectal prostate biopsy. The current practice is to give patients a
dose of an oral fluoroquinolone (FQ) 30 to 60 minutes before biopsy and to be continued for
2 to 3 days after.
Recent studies show that 2% of patients will develop febrile urinary tract infection or even
urosepsis and require hospitalization for intravenous antibiotics . There is considerable
concern regarding the rising incidence of community-acquired antibiotic-resistant organisms.
It is proposed that resistant organisms are introduced into the bladder and the blood stream
from the rectum during the procedure that's why patients already colonized with these
resistant organisms may be at higher risk. Thereby, some authors suggest a targeted rectal
swab culture before (TRUS)-guided biopsy then giving the appropriate antibiotic prophylaxis
aiming at reducing post biopsy infection rates while minimizing unnecessary broad-spectrum
antibiotic use.
Retrospective data showed that septicemia was seen in 24 of 300 (8%) and 15 of 897 (1. 7%) in
patients receiving peri-procedure ciprofloxacin alone and patients receiving ciprofloxacin
plus single IV dose of amikacin injection respectively (p=0. 001). E. Coli resistant to
quinolones was responsible for 33 of 39 (84. 6%) septicemic cases. In a retrospective study
in UK, 12. 9% developed infectious complications following prostate biopsy in patients
receiving co-amoxiclav and gentamycin.
In another retrospective study, hospitalization rate due to post-biopsy infections was 3. 8%
compared to 0. 6% (p=0. 001) in patients receiving the standard ciprofloxacin and augmented
prophylaxis with ciprofloxacin plus single IM 80mg gentamycin respectively. Of the admitted
patients who received standard prophylaxis, 73% had fluoroquinolone resistant E. Coli
urinary infection and/or bacteremia and only 9% had strains resistant to gentamicin.
Multivariate analysis showed that the standard regimen was significantly associated with
hospital admission due to post-biopsy infection. The augmented regimen resulted in a cost
savings of $15,700 per 100 patients compared to the standard regimen.
Diabetes was found in 4% of the fluoroquinolone sensitive group vs 14. 7% of the resistant
group (p < 0. 001). Biopsy history was not associated with resistance.
Urosepsis is a systemic reaction of the body to a bacterial infection of the urogenital
organs with the risk of life-threatening events including shock. Systemic inflammatory
response syndrome (SIRS) criteria are defined as 2 or more of the following variables;
increase in body temperature to 38°C or more, heart rate of more than 90 beats per minute,
respiratory rate of more than 20 per minute or arterial carbon dioxide tension (PaCO2) less
than 32mm Hg and abnormal white blood cell count (>12,000/µL or < 4,000/µL) Aim of the work;
The aim of the study is to evaluate whether changing antibiotic prophylaxis from
fluoroquinolones alone to fluoroquinolones plus gentamicin 160mg single IM dose or targeted
antibiotic prophylaxis according to rectal swab culture would influence infectious
complication rates in those men undergoing transrectal ultrasound-guided prostate biopsy.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
1. Prothrombin concentration > 70%
2. Platelet count > 100. 000/cm
Exclusion Criteria:
1. Acute prostatitis (positive symptoms and signs)
2. Patients with compromised renal function (serum creatinine >1. 6 mg/dl)
3. Uncontrolled DM
4. Patients on immunosuppressive therapy
5. Active steroid intake
6. Untreated bleeding diathesis
Locations and Contacts
ahmed m elshal, MD, Phone: +201001855490, Email: ELSHALAM@HOTMAIL.COM
Urology and Nprhology Center, Mansoura, Aldakahlia 35516, Egypt; Recruiting ahmed m elshal, md, Email: elshalam@hotmail.com
Additional Information
Starting date: March 2015
Last updated: April 21, 2015
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