Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000149763
Ethics application status
Approved
Date submitted
31/07/2021
Date registered
28/01/2022
Date last updated
6/02/2023
Date data sharing statement initially provided
28/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rectal and urethral flora in patients undergoing transrectal ultrasound guided prostate biopsy: clinical implications.
Scientific title
Comparison of infectious complications in patients undergoing transrectal ultrasound guided prostate biopsy receiving targeted antibiotic prophylaxis according to rectal and expressed prostatic secretion swab cultures versus empiric antibiotic prophylaxis: a prospective cohort study.
Secondary ID [1] 304087 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary tract infections 322203 0
Infectious complications of transrectal ultrasound guided prostate biopsy 322204 0
Prostate cancer 322205 0
Prostatitis 322206 0
Condition category
Condition code
Infection 319896 319896 0 0
Other infectious diseases
Renal and Urogenital 319897 319897 0 0
Other renal and urogenital disorders
Cancer 319898 319898 0 0
Prostate
Surgery 321646 321646 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in intervention group are subjected to cultures of rectal swab and urethral swab of expressed prostatic secretions. At the time of the first visit samples are collected by a single urologist. At first, rectal swab sample is retrieved, followed by digital rectal examination and prostatic massage. Finally, urethral swab is used to collect expressed prostatic secretions. The sample is collected after retraction of prepuce and cleaning of urethral meatus with normal saline. A swab is then inserted approximately 2cm into urethra. Samples are sent to microbiology department for cultures. A predetermined antibiotic panel was used for rectal cultures with the following anibiotics: amoxycillin, ampicillin, amoxycillin/clavulanic acid, cefaclor, ceftazidime, amikacin, imipenem, norfloxacin, levofloxacin, ciprofloxacin, tigecycline, colistin and gentamycin. The antibiotic panel used for urethral cultures varied according to isolated bacteria.
Based on culture results, patients are contacted and instructed to receive targeted antibiotic prophylaxis for a total of 5 days, initiated 1 day prior to prostate biopsy. Antibiotic selection was guided by known allergies, antimicrobial sensitivity, the provided minimum inhibitory concentration (MIC) and in compliance with the local antibiotic protocol of the department, which also determined the dose of the selected antibiotics. No complimentary instructions are given regarding pre-biopsy enema. Patients are subjected to twelve core TRUS-PBx with an 18G biopsy needle by a urologist. The approximate duration of the procedure is 10 to 15 minutes. The occurrence of infectious complications is investigated and verified at the time of biopsy results announcement by interviewing patients. At the same time, patients' adherence to given instructions is investigated by interviewing the patients and by drug tablet return.
The allocation to the groups was carried out during the first visit to Urology outpatient clinic. Those not willing to give samples for culture and those who were referred by office urologists, directly for TRUS-Bx, were assigned to empiric antibiotic prophylaxis group and the rest of the patients were assigned to targeted antibiotic prophylaxis group.
Intervention code [1] 320763 0
Prevention
Intervention code [2] 322088 0
Treatment: Drugs
Comparator / control treatment
Standard (empiric) antibiotic prophylaxis, initiated 1 day prior to prostate biopsy and for 5 days in total, with ciprofloxacin 500mg tablets, twice per day, orally.
The occurrence of infectious complications is investigated and verified at the time of biopsy results announcement. At the same time, patients' adherence to given instructions is investigated.
Control group
Active

Outcomes
Primary outcome [1] 327770 0
Difference between two groups in infectious complications rates after transrectal ultrasound guided prostate biopsy. Apart from total incidence, three main infectious complications categories are recorded: febrile urinary tract infection (UTI), afebrile UTI (lower urinary tract symptoms with urinalysis and/or urine culture findings indicating UTI) and hospitalization for febrile UTI. Febrile UTI and hospitalization can be overlapping. Infectious complications are assessed by interviewing patients when their biopsy results are discussed with them.
Timepoint [1] 327770 0
From the day of biopsy until two weeks post-biopsy.
Secondary outcome [1] 396536 0
Rectal flora resistance to fluoroquinolones, assesed using rectal swabs.
Timepoint [1] 396536 0
At the time of microbial cultures.
Secondary outcome [2] 402532 0
Urethral (expressed prostatic secretions) flora resistance to fluoroquinolones, using urethral swab.
Timepoint [2] 402532 0
At the time of microbial cultures.

Eligibility
Key inclusion criteria
Male patients with clinical and/or laboratory findings indicative of prostate cancer, namely abnormal digital rectal examination findings, elevated prostate specific antigen and suspicious imaging. Also, patients with previous non diagnostic biopsies who undergo a repeat biopsy.
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of indwelling bladder catheter.
Inability to receive the proposed antibiotic prophylaxis (i.e allergies).
Patients subjected to saturation biopsy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/08/2019
Date of last participant enrolment
Anticipated
31/01/2022
Actual
31/01/2022
Date of last data collection
Anticipated
28/02/2022
Actual
28/02/2022
Sample size
Target
200
Accrual to date
Final
141
Recruitment outside Australia
Country [1] 23754 0
Greece
State/province [1] 23754 0

Funding & Sponsors
Funding source category [1] 308471 0
Self funded/Unfunded
Name [1] 308471 0
Country [1] 308471 0
Primary sponsor type
Individual
Name
Sotirios Gatsos
Address
General Hospital of Thessaloniki "O Agios Dimitrios", Elenis Zografou 2,Thessaloniki, 54634
Country
Greece
Secondary sponsor category [1] 309312 0
None
Name [1] 309312 0
Address [1] 309312 0
Country [1] 309312 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308427 0
Scientific Committee of General Hospital of Thessloniki "O Agios Dimitrios"
Ethics committee address [1] 308427 0
Ethics committee country [1] 308427 0
Greece
Date submitted for ethics approval [1] 308427 0
02/08/2019
Approval date [1] 308427 0
28/08/2019
Ethics approval number [1] 308427 0
10079/02-08-2019

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110670 0
Mr Sotirios Gatsos
Address 110670 0
General Hospital of Thessaloniki "O Agios Dimitrios", Elenis Zografou 2,Thessaloniki, 54634
Country 110670 0
Greece
Phone 110670 0
+306976778108
Fax 110670 0
Email 110670 0
[email protected]
Contact person for public queries
Name 110671 0
Sotirios Gatsos
Address 110671 0
General Hospital of Thessaloniki "O Agios Dimitrios", Elenis Zografou 2,Thessaloniki, 54634
Country 110671 0
Greece
Phone 110671 0
+306976778108
Fax 110671 0
Email 110671 0
[email protected]
Contact person for scientific queries
Name 110672 0
Sotirios Gatsos
Address 110672 0
General Hospital of Thessaloniki "O Agios Dimitrios", Elenis Zografou 2,Thessaloniki, 54634
Country 110672 0
Greece
Phone 110672 0
+306976778108
Fax 110672 0
Email 110672 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12733Informed consent form  [email protected] 381903-(Uploaded-31-07-2021-17-15-37)-Study-related document.docx
12734Ethical approval  [email protected] 381903-(Uploaded-31-07-2021-17-15-09)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.