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Trial registered on ANZCTR


Registration number
ACTRN12616001344482
Ethics application status
Approved
Date submitted
5/09/2016
Date registered
26/09/2016
Date last updated
7/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the efficacy of prulifloxacin against cefixime as a preventive treatment before transrectal ultrasound guided prostate biopsy.
Scientific title
Evaluating the efficacy of prulifloxacin against cefixime administration before a transrectal prostate biopsy, in order to avoid severe urinary sepsis after the performance.
Secondary ID [1] 290098 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer suspicious 300185 0
Urinary tract infection 300258 0
Condition category
Condition code
Renal and Urogenital 300069 300069 0 0
Other renal and urogenital disorders
Cancer 300123 300123 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients eligible for prostate biopsy will receive either oral tablet prulifloxacin 600mg once daily for three days (Group 1) or oral tablet cefixime 400mg (Group 2) once daily for three days, as prevention treatment before biopsy. Monitoring will be based on high fever followed with lower urinary tract symptoms up to 3 days after the performance,
The adherence to the treatment will be checked, as patinets are asked to recieve each drug some hours before biopsy, inside the urology department.
Intervention code [1] 295833 0
Prevention
Intervention code [2] 295891 0
Treatment: Drugs
Comparator / control treatment
Cefixime/ Prulifloxacin (control treatment)
Control group
Active

Outcomes
Primary outcome [1] 299539 0
High fever with lower urinary tract symptoms

These will be chcked by self thermometry by the patient, as well as medical history is required.
Timepoint [1] 299539 0
1 day after prostate biopsy
Secondary outcome [1] 327473 0
Severe sepsis
Evaluation will be performed with:

Blood and urine examintaions and cultures.
Blood gas, respiratory frequence, blood pressure.

Timepoint [1] 327473 0
3 days after prostate biopsy

Eligibility
Key inclusion criteria
Patients eligible for prostate biopsy
Minimum age
40 Years
Maximum age
75 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Prulifloxacin or cefixime allergy

Kidney failure,

Known resistance to prulifloxacin or cefixime

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8194 0
Greece
State/province [1] 8194 0
Thessaly

Funding & Sponsors
Funding source category [1] 294466 0
University
Name [1] 294466 0
University of Thessaly
Address [1] 294466 0
Mezourlo, 41100, Larissa

Country [1] 294466 0
Greece
Primary sponsor type
University
Name
University of Thessaly
Address
Mezourlo 41100 Larissa

Country
Greece
Secondary sponsor category [1] 293332 0
None
Name [1] 293332 0
Address [1] 293332 0
Country [1] 293332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295896 0
Scientific Committee University Hospital of Larisa
Ethics committee address [1] 295896 0
Viopolis Mezourlo
41100
Larisa
Ethics committee country [1] 295896 0
Greece
Date submitted for ethics approval [1] 295896 0
25/07/2016
Approval date [1] 295896 0
01/08/2016
Ethics approval number [1] 295896 0
30025

Summary
Brief summary
Patients eligible for prostate biopsy, either after a high PSA or a DRE finding, will receive a dose of prulifloxacin 600mg (Group 1) or cefixime 400mg (Group 2) before the performance, in order to test if lower urinary tract infection or sepsis can be prevented. They will be evaluated for urinary infection in the following 3 days, based on fever and lower urinary tract symptoms. The results will be statistically studied so as to prove any difference between the two Groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68842 0
Prof Vasileios Tzortzis
Address 68842 0
Urology Assistant Profesor, Urology Department of University of Thessaly
Viopolis Mezourlo
41100
Larisa
Country 68842 0
Greece
Phone 68842 0
+302413502811
Fax 68842 0
Email 68842 0
tzorvas@otenet.gr
Contact person for public queries
Name 68843 0
Dr Michael Samarinas
Address 68843 0
Urologist, Urology Department of University of Thessaly
Viopolis Mezourlo
41100
Larisa
Country 68843 0
Greece
Phone 68843 0
+306946006798
Fax 68843 0
Email 68843 0
mikesamih@hotmail.com
Contact person for scientific queries
Name 68844 0
Dr Michael Samarinas
Address 68844 0
Urology Resident, Urology Department of University of Thessaly
Viopolis Mezourlo
41100
Larisa
Country 68844 0
Greece
Phone 68844 0
+306946006798
Fax 68844 0
Email 68844 0
mikesamih@hotmail.com

No information has been provided regarding IPD availability
Summary results
No Results