UrosepsisProphylaxis001NCT04212403
Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)
A study testing Levofloxacin in people with Urosepsis and Bladder Cancer, run by Jessa Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urosepsis, Bladder Cancer, Prostate Hyperplasia
- What is being tested?
- Levofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Sep 2018to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TURP or TURB.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Urosepsis, Bladder Cancer, Prostate Hyperplasia, Antibiotic Resistant Strain, Antibiotic Resistant Infection, Antibiotic-associated Diarrhea
- Being tested
- Levofloxacin
- Keywords
- TURP, TURB
- Medical subject headings
- Urinary Bladder Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
The control group receives AMP.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines. Receives: Drug: Levofloxacin |
| Treatment group | No intervention | The treatment group receives no AMP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with a post-operative infection.
Urosepsis, fever (t°> 38.5) or epididymitis.
Measured: From immediately post-op until at the control consultation 4 weeks after surgery.
Secondary outcomes (1)
Incidence of post-operative bacteriuria.
> 100.000 bacteria/mL urine
Measured: From immediately post-op until at the control consultation 4 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start17 Sep 2018
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrosepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Koenraad van Renterghem, PhD, Principal investigator, UHasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212403
- Sponsor's protocol ID
- JessaH_B243201733480
- Acronym
- Prophylaxis001
- Status last verified
- Feb 2020
- First submitted
- 6 Aug 2019
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04212403
- Acronym / sponsor ID
- Prophylaxis001 / JessaH_B243201733480
- Conditions
- Urosepsis, Bladder Cancer, Prostate Hyperplasia, Antibiotic Resistant Strain, Antibiotic Resistant Infection, Antibiotic-associated Diarrhea
- Keywords
- TURP, TURB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,350 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 27 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: LevofloxacinThe control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines. |
| Treatment group | No intervention | –The treatment group receives no AMP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- TURP or TURB.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevofloxacinThe control group receives AMP. | Drug | Control |
Primary outcome
% of patients with a post-operative infection.
Time frame: From immediately post-op until at the control consultation 4 weeks after surgery.
Urosepsis, fever (t°> 38.5) or epididymitis.
1 secondary outcome
Incidence of post-operative bacteriuria.
Time frame: From immediately post-op until at the control consultation 4 weeks after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koenraad van Renterghem, PhD principal investigator
UHasselt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levofloxacin in people with Urosepsis and Bladder Cancer, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients with a post-operative infection. (time frame: From immediately post-op until at the control consultation 4 weeks after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.