Clinical trial NCT02423759: A Trial Assessing Peri-procedure Chemoprophylaxis During Transrectal Prostate Needle Biopsy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostate Hyperplasia
Keywords: Chemoprevention
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 510
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: occurrence of post procedure infectious complications
timeFrame: 2 weeks
Secondary outcomes:
measure: flouroquinolones resistance in rectal carriage
timeFrame: 2 weeks
measure: post procedure non-infectious complications
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nprhology Center
state: Aldakahlia
Study officials:
affiliation: Mansoura University
name: Ahmed M Elshal, MD
role: PRINCIPAL_INVESTIGATOR
References: