Urinary Tract InfectionsPhase 4BIPROSTNCT01803191
Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy
A Phase 4 study testing Fosfomycin 3 g and Ciprofloxacin 500 mg in people with Urinary Tract Infections, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 3 sites in Spain.
Trial summary
The purpose of this clinical trial is compare the incidence of symptomatic or asymptomatic bacteriuria after transrectal ultrasound guided prostate biopsy using a single dose of fosfomycin 3 g one hour before the biopsy compared to observed with the use of a single dose of ciprofloxacin 500 mg 1 hour before biopsy. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Fosfomycin 3 g and Ciprofloxacin 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 3 sitesSpain
- Study dates
- Aug 2012to 25 Jan 2016
- Phase
- Phase 4
- 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patients with prostate-specific antigen (PSA) values >4 ng/ml or presenting either abnormality in rectal examination
- Patients who accept to participate in the study signing the consent informed form
Who cannot join
- Allergy to anyone of the study drug
- Intolerance to anyone of the study drug
- Urinary infection with positive uroculture
- Clinical finds suggesting infections
- Antimicrobial treatment during the las 4 weeks
- Patients with vesicle catheter
- Patients in dialysis
- Patients in hemodialysis
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital General Universitario Santa Lucía
Cartagena, Murcia, 30202
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30150
Hospital General Universitario Los Arcos del Mar Menor
San Javier, Murcia, 30739
About this study
Official title: Randomized Controlled Clinical Trial of Efficacy of Fosfomycin Versus Ciprofloxacin as Antibiotic Prophylaxis Prior to Ultrasound Guided Transrectal Prostate Biopsy
The purpose of this clinical trial is compare the incidence of symptomatic or asymptomatic bacteriuria after transrectal ultrasound guided prostate biopsy using a single dose of fosfomycin 3 g one hour before the biopsy compared to observed with the use of a single dose of ciprofloxacin 500 mg 1 hour before biopsy.
Read the detailed description
Transrectal ultrasound guided (TRUS) prostate biopsy is the procedure of choice for the diagnosis of prostate cancer. This technique is usually safe and well tolerated with a low incidence of serious complications. However, one of these complications, the bacterial infection can be complicated and cause urinary sepsis. The investigators have developed different regimens of antibiotic prophylaxis. Most of them include administering oral fluoroquinolones. In this area, approximately 40% of the strains of E. coli are resistant to ciprofloxacin (fluoroquinolone). Therefore, research is warranted alternative prophylactic approaches. Fosfomycin is an antibiotic ancient underused in recent decades that in recent years has been proposed as an alternative treatment for infections caused by multidrug-resistant microorganisms.
- Conditions
- Urinary Tract Infections
- Being tested
- Fosfomycin 3 g, Ciprofloxacin 500 mg
- Keywords
- Transrectal ultrasound-guided prostate biopsy, Bacteriuria, Antibiotic prophylaxis, Prostate-Specific antigen
- Medical subject headings
- Urinary Tract Infections, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosfomycin 3 gDrug
Unique oral dosis of fosfomycin 1 hour before biopsy
Ciprofloxacin 500 mgDrug
Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy
| Study group | Role | What they receive |
|---|---|---|
| Fosfomycin 3 g | Experimental | Unique oral dosis of 3 g of fosfomycin 1hour before of biopsy Receives: Drug: Fosfomycin 3 g |
| Ciprofloxacin 500 mg | Active comparator | Unique oral dosis of ciprofloxacin 500 mg before biopsy Receives: Drug: Ciprofloxacin 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriuria
Positive urine culture(>10000 ufc/ml)
Measured: 28 days
Secondary outcomes (11)
Urinary Tract Infection
clinical symptoms (burning urination, urgent urination, urinary frequency)
Measured: 28 days
Sepsis
Systemic inflammatory response syndrome secondary to urinary tract infection
Measured: 28 days
Pathogens present in urine and antimicrobial resistance
Measured: 28 days
Bacteremia
Presence of bacteria in the blood (blood culture positive)
Measured: 28 days
Hematuria
Blood in urine (Complication of transrectal ultrasound guided prostate)
Measured: 28 days
Hemospermia
Blood in the semen (Complication of transrectal ultrasound guided prostate)
Measured: 28 days
Rectal bleeding
Loss of red blood through the anus(Complication of transrectal ultrasound guided prostate)
Measured: 28 days
Urinary retention
Complication of transrectal ultrasound guided prostate
Measured: 28 days
Difficulty for miction
Complication of transrectal ultrasound guided prostate
Measured: 28 days
Genitourinary infections associated to fever (>38ºC)
Fever >38ºC with some of this symptoms: dysuria, polyuria or suprapubic ache
Measured: 28 days
Number of participants with adverse events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startAug 2012
- Primary completion25 Jan 2016
- Study completion25 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Santa Lucía, Hospital General Universitario Los Arcos del Mar Menor
- Responsible party
- Sponsor
- Investigators
- Pedro PL Lopez Cubillana, MD, Principal investigator, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803191
- Sponsor's protocol ID
- BIPROST
- Other IDs
- 2012-001031-31
- Acronym
- BIPROST
- Status last verified
- Mar 2017
- First submitted
- 14 Feb 2013
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial of Efficacy of Fosfomycin Versus Ciprofloxacin as Antibiotic Prophylaxis Prior to Ultrasound Guided Transrectal Prostate Biopsy
- ClinicalTrials.gov ID
- NCT01803191
- Acronym / sponsor ID
- BIPROST / BIPROST
- Conditions
- Urinary Tract Infections
- Keywords
- Transrectal ultrasound-guided prostate biopsy, Bacteriuria, Antibiotic prophylaxis, Prostate-Specific antigen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Collaborators
- Hospital General Universitario Santa Lucía, Hospital General Universitario Los Arcos del Mar Menor
- Study start
- Aug 2012 (actual)
- Primary completion
- 25 Jan 2016 (actual)
- Study completion
- 25 Jan 2016 (actual)
- First posted
- 4 Mar 2013 (estimated)
- 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.
The purpose of this clinical trial is compare the incidence of symptomatic or asymptomatic bacteriuria after transrectal ultrasound guided prostate biopsy using a single dose of fosfomycin 3 g one hour before the biopsy compared to observed with the use of a single dose of ciprofloxacin 500 mg 1 hour before biopsy.
Detailed description
Transrectal ultrasound guided (TRUS) prostate biopsy is the procedure of choice for the diagnosis of prostate cancer. This technique is usually safe and well tolerated with a low incidence of serious complications. However, one of these complications, the bacterial infection can be complicated and cause urinary sepsis. The investigators have developed different regimens of antibiotic prophylaxis. Most of them include administering oral fluoroquinolones. In this area, approximately 40% of the strains of E. coli are resistant to ciprofloxacin (fluoroquinolone). Therefore, research is warranted alternative prophylactic approaches. Fosfomycin is an antibiotic ancient underused in recent decades that in recent years has been proposed as an alternative treatment for infections caused by multidrug-resistant microorganisms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fosfomycin 3 g | Experimental | Drug: Fosfomycin 3 gUnique oral dosis of 3 g of fosfomycin 1hour before of biopsy |
| Ciprofloxacin 500 mg | Active comparator | Drug: Ciprofloxacin 500 mgUnique oral dosis of ciprofloxacin 500 mg before biopsy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Patients with prostate-specific antigen (PSA) values >4 ng/ml or presenting either abnormality in rectal examination
- Patients who accept to participate in the study signing the consent informed form
Key exclusion criteria (8 listed)
- Allergy to anyone of the study drug
- Intolerance to anyone of the study drug
- Urinary infection with positive uroculture
- Clinical finds suggesting infections
- Antimicrobial treatment during the las 4 weeks
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 |
|---|---|---|
| Fosfomycin 3 gUnique oral dosis of fosfomycin 1 hour before biopsy | Drug | Fosfomycin 3 g |
| Ciprofloxacin 500 mgUnique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy | Drug | Ciprofloxacin 500 mg |
Primary outcome
Bacteriuria
Time frame: 28 days
Positive urine culture(>10000 ufc/ml)
11 secondary outcomes
Urinary Tract Infection
Time frame: 28 days
Sepsis
Time frame: 28 days
Pathogens present in urine and antimicrobial resistance
Time frame: 28 days
Bacteremia
Time frame: 28 days
Hematuria
Time frame: 28 days
Hemospermia
Time frame: 28 days
Rectal bleeding
Time frame: 28 days
Urinary retention
Time frame: 28 days
Difficulty for miction
Time frame: 28 days
Genitourinary infections associated to fever (>38ºC)
Time frame: 28 days
Number of participants with adverse events
Time frame: 28 days
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 13 Dec 2017.
Related trials for Urinary Tract Infections
Recruiting
Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture
Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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.
Pedro PL Lopez Cubillana, MD principal investigator
Hospital Universitario Virgen de la Arrixaca
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fosfomycin 3 g and Ciprofloxacin 500 mg in people with Urinary Tract Infections, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 3 sites in Spain.
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 3 inclusion and 8 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 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bacteriuria (time frame: 28 days). 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 13 Dec 2017.