Prophylaxis001: Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)

Sponsor

Jessa Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04212403

Collaborator

(none)

1,350

Enrollment

Location

Arms

15.2

Actual Duration (Months)

88.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the use of antibiotic prophylaxis in patients undergoing TURP and TURB. The investigators set up a prospective, randomized controlled trial in which (after exclusion of risk factors) patients will be randomized in receiving levofloxacin (Tavanic) orally or no antibiotics. The exclusion criteria for TURP are a pre-operative transurethral catheter or > 100 urinary white blood cells in the pre-operative urine sample. The exclusion criteria for TURB are a pre-op catheter or clinical signs of infection.

Condition or Disease	Intervention/Treatment	Phase
Urosepsis Bladder Cancer Prostate Hyperplasia Antibiotic Resistant Strain Antibiotic Resistant Infection Antibiotic-associated Diarrhea Antibiotic Toxicity	Drug: Levofloxacin	N/A

Detailed Description

Main objective:

To investigate the safety of omitting antibiotic prophylaxis in TURP (transurethral resection of the prostate) and TURB (transurethral bladder tumour resection) in patients without a pre-operative catheter or > 100 WBC in the pre-operative urinary sample (TURP) or clinical signs of urinary infection (TURB).

Secondary objective:

To investigate post-operative bacteriuria after TURB and TURP in our population.

Principal inclusion criterium:

Patients undergoing TURP or TURB.

Primary exclusion criterium:

TURP: pre-operative catheter or > 100 white blood cells in the pre- operative urinary sample.

TURB: pre-operative catheter or clinical signs of infection (fever, nyctalgia).

Primary endpoint:

Post-operative infection.

Secondary endpoint:

Post-operative bacteriuria.

Study Design

Study Type:

Interventional

Actual Enrollment :

1350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, controlled trial.Randomized, controlled trial.

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial

Actual Study Start Date :

Sep 17, 2018

Actual Primary Completion Date :

Dec 23, 2019

Actual Study Completion Date :

Dec 23, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.	Drug: Levofloxacin The control group receives AMP.
No Intervention: Treatment group The treatment group receives no AMP.

Arm

Intervention/Treatment

Active Comparator: Control

The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.

Drug: Levofloxacin

The control group receives AMP.

No Intervention: Treatment group

The treatment group receives no AMP.

Outcome Measures

Primary Outcome Measures

% of patients with a post-operative infection. [From immediately post-op until at the control consultation 4 weeks after surgery.]
Urosepsis, fever (t°> 38.5) or epididymitis.

Secondary Outcome Measures

Incidence of post-operative bacteriuria. [From immediately post-op until at the control consultation 4 weeks after surgery.]
> 100.000 bacteria/mL urine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

TURP or TURB.

Exclusion Criteria:

TURP: pre-operative catheter/DJ/nephrostomy or > 100 white blood cells in the pre- operative urinary sample.

TURB: pre-operative catheter/DJ/nephrostomy or clinical signs of infection (fever, myctalgia).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jessa Ziekenhuis	Hasselt	Limburg	Belgium	3050

Sponsors and Collaborators

Jessa Hospital

Investigators

Principal Investigator: Koenraad van Renterghem, PhD, UHasselt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jessa Hospital

ClinicalTrials.gov Identifier:

NCT04212403

Other Study ID Numbers:

JessaH_B243201733480

First Posted:

Dec 27, 2019

Last Update Posted:

Feb 24, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Jessa Hospital

TURP

TURB

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Prostatic Hyperplasia

Study Results

No Results Posted as of Feb 24, 2020