Chronic Bacterial ProstatitisPhase 2NCT03201796
Prulifloxacin in Chronic Bacterial Prostatitis (CBP)
A Phase 2 study testing Prulifloxacin 600 mg and Levofloxacin 500mg in people with Chronic Bacterial Prostatitis, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 11 sites in 2 countries.
Trial summary
The aim of the study is to assess the efficacy and safety of prulifloxacin in comparison to levofloxacin in the treatment of patients affected by CBP. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Chronic Bacterial Prostatitis
- What is being tested?
- Prulifloxacin 600 mg and Levofloxacin 500mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 2 Feb 2016to 19 May 2020
- Phase
- Phase 2
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male between 18 and 50 years of age (limited included) with no limitation of race.
- Patients presenting symptoms of prostatitis for at least 3 months.
- Laboratory evidence of CBP at Visit 0 (Screening), assessed by
- Meares\&Stamey fourglass test and defined as:
- VB3 or EPS specimen containing ≥10^2 colony-forming units/ml of pathogen/s if the VB2 specimen is sterile; or
- VB3 or EPS specimen containing ≥10^2 colony-forming units/ml of pathogen/s different from any present in the VB2.
- Medications for chronic prostatitis and/or medications that may affect bladder or prostate function (including but not limited to hormone therapy, anticholinergic or alpha blocker) must be discontinued at least 7 days before study drug intake.
- Patients legally capable to give their consent to participate the study, and available to sign and date the written informed consent.
Who cannot join
- Known hypersensitivity or allergy to antibacterial fluoroquinolones or to any components of the study medications.
- Pathogen/s resistant to the study drugs at Visit 0 (Screening).
- Suspicion for prostatic cancer, neurogenic bladder, Benign Prostatic Hypertrophy (BPH), bladder neck obstruction or urethral stricture.
- Body Mass Index (BMI) < 16 kg/m^2.
- Immunocompromised patients.
- Signs or symptoms or clinical documentation for concurrent infections (including but not limited to sexually transmitted infections) and/or neoplasm.
Show all 25Show fewer
- Clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests at Visit 0 (Screening Visit).
- Significant liver disease, defined as known active hepatitis or elevated liver enzymes > 3 times the upper boundary of the normal ranges.
- Value of creatinine outside the normal ranges and judged clinically relevant by Investigator.
- History of cardiac disease, including but not limited to myocardial infarction, heart failure, cardiomyopathy, cardiac hypertrophy, cardiac arrhythmias, bradycardia, cardiac conduction abnormalities, long QT syndrome.
- Value of electrolytes (sodium, potassium, calcium, magnesium, chloride) outside the normal ranges and judged clinically relevant by Investigator.
- Patients under treatment with medications that may cause increase of the QT interval.
- History of tendinopathy.
- Patients with latent or known deficiencies for the glucose-6-phosphate dehydrogenase, or with hereditary problems of galactose intolerance or the Lapp lactase deficiency or glucose-galactose malabsorption.
- Recent or past history of psychiatric illness or epilepsy.
- Treatment with antibiotics or antibacterials within 2 weeks before study drug start intake.
- Treatment with experimental drugs (prulifloxacin or levofloxacin) or other fluoroquinolones within 4 weeks before study drug start intake.
- Diabetic patients in treatment with oral hypoglycemic drugs and insulin.
- Patients under treatment with corticosteroids or Non-Steroidal Antiflammatory Drugs (NSAIDs).
- Concomitant treatment with xanthines or anticoagulant drugs or drugs producing hypokalemia or diuretics.
- Positive history for drugs and alcohol abuse.
- Inability to comply with the protocol requirements, instructions or study-related restrictions (i.e. uncooperative attitude, inability to return for study-visits, improbability of completing the clinical study).
- Vulnerable subjects (i.e. persons kept in detention).
- Subject involved in the conduct of the study (i.e. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel).
- Participation to an interventional clinical trial within 3 months prior to Visit 0 (Screening Visit).
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Italy9 sites
U.O. di Urologia- Azienda Ospedaliera San Giuseppe Moscati
Avellino, 83100
U.O. Dipartimento della Donna, del bambino e delle malattie urologiche - Azienda ospedaliero- Universitaria e Policlinico di Bologna
Bologna, 40138
Urologia- Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"
Catania, 95123
Clinica Urologica- Azienda Ospedaliero Universitaria Mater Domini
Catanzaro
Azienda Ospedaliero-Universitaria "Careggi"
Florence, 50134
Azienda Ospedaliera Universitaria "Federico II"- Dip. Di Ostreticia, ginecologia, Urologia
Naples, 80131
Clinica Urologica del Dipartimento di Scienze Chirurgiche- Policlinico Universitario Agostino Gemelli di Roma
Roma, 00168
S.C. Urologia- AO "Città della Salute e della Scienza" di Torino - OSP.S. GIOV.BATTISTA MOLINETTE
Torino, 10126
Urologia- Ospedale di Trento- Presidio ospedaliero S. Chiara - Azienda Provinciale per i servizi sanitari (APSS)
Trento, 38123
Greece2 sites
Urology Clinic General Hospital of Athens "GENNIMATAS"
Athens, 15669
Urology Department General Hospital of Piraeus "TZANEIO"
Piraeus, 18536
About this study
Official title: Evaluation of the Efficacy and Safety of Prulifloxacin vs Levofloxacin in the Treatment of Chronic Bacterial Prostatitis.
The aim of the study is to assess the efficacy and safety of prulifloxacin in comparison to levofloxacin in the treatment of patients affected by CBP.
Read the detailed description
This is a randomized, double-blind, levofloxacin controlled, parallel group, multicentre, international, prospective study. The patients will be enrolled in the study and will be randomized to prulifloxacin or levofloxacin. Patient enrolment will be competitive.
The present study is planned to verify the microbiological and the clinical efficacy of a 28-day treatment period with prulifloxacin 600 mg in comparison with 28-day treatment period with levofloxacin 500 mg, both administered once daily, in patients with CBP. Safety and tolerability of a 28-day treatment period with prulifloxacin 600 mg will be also evaluated in comparison to levofloxacin 500 mg.
Levofloxacin 500 mg tablets has been selected as treatment comparator because it represents the drug of choice authorised for the treatment of CBP. Consequently, the dosage regimen to be administered to the patients is consistent with that reported in the relevant SPC.
- Conditions
- Chronic Bacterial Prostatitis
- Being tested
- Prulifloxacin 600 mg, Levofloxacin 500mg
- Keywords
- Bacterial prostatitis, CBP, Levofloxacin, Prulifloxacin
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prulifloxacin 600 mgDrug
Also called Unidrox®
Oral administration of one tablet once daily for 28 days of prulifloxacin 600 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium.
Levofloxacin 500mgDrug
Also called Levoxacin®
Oral administration of one tablet once daily for 28 days of levofloxacin 500 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Prulifloxacin 600 mg Receives: Drug: Prulifloxacin 600 mg |
| Group 2 | Active comparator | Levofloxacin 500 mg Receives: Drug: Levofloxacin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of bacterial growth
Eradication defined as absence of bacterial growth as <10^2 CFU/ml in voided bladder 3 (VB3) or expressed prostatic secretion (EPS) after 7 days from the End Of Treatment (EOT).
Measured: 7 days after the EOT
Secondary outcomes (6)
Eradication of bacterial growth
Eradication defined as absence of bacterial growth as <10^2 CFU/ml in voided bladder 3 (VB3) or expressed prostatic secretion (EPS) after 3 months from the EOT.
Measured: 3 months after the EOT
Eradication of bacterial growth
Eradication defined as absence of bacterial growth as <10^2 CFU/ml in voided bladder 3 (VB3) or expressed prostatic secretion (EPS) after 6 months from the EOT.
Measured: 6 months after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Reduction of total score in NIH-CPSI after 7 days from the EOT in comparison to the screening.
Measured: Screening - 7 days after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Reduction of total score in NIH-CPSI after 3 months from the EOT in comparison to the screening.
Measured: Screening - 3 months after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Reduction of total score in NIH-CPSI after 6 months from the EOT in comparison to the screening.
Measured: Screening - 6 months after the EOT
Frequency of treatment-related adverse events
Monitoring of the frequency of adverse events, physical examination, vital signs, ECG, laboratory analyses.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start2 Feb 2016
- Primary completion19 May 2020
- Study completion19 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Bacterial ProstatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, levofloxacin controlled, multicentre, international, prospective study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201796
- Sponsor's protocol ID
- 027IC13250
- Other IDs
- 2014-003757-33, 2014
- Status last verified
- May 2021
- First submitted
- 23 Jun 2017
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Prulifloxacin vs Levofloxacin in the Treatment of Chronic Bacterial Prostatitis.
- ClinicalTrials.gov ID
- NCT03201796
- Acronym / sponsor ID
- 027IC13250
- Conditions
- Chronic Bacterial Prostatitis
- Keywords
- Bacterial prostatitis, CBP, Levofloxacin, Prulifloxacin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 28 Jun 2017 (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.
The aim of the study is to assess the efficacy and safety of prulifloxacin in comparison to levofloxacin in the treatment of patients affected by CBP.
Detailed description
This is a randomized, double-blind, levofloxacin controlled, parallel group, multicentre, international, prospective study. The patients will be enrolled in the study and will be randomized to prulifloxacin or levofloxacin. Patient enrolment will be competitive.
The present study is planned to verify the microbiological and the clinical efficacy of a 28-day treatment period with prulifloxacin 600 mg in comparison with 28-day treatment period with levofloxacin 500 mg, both administered once daily, in patients with CBP. Safety and tolerability of a 28-day treatment period with prulifloxacin 600 mg will be also evaluated in comparison to levofloxacin 500 mg.
Levofloxacin 500 mg tablets has been selected as treatment comparator because it represents the drug of choice authorised for the treatment of CBP. Consequently, the dosage regimen to be administered to the patients is consistent with that reported in the relevant SPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind, levofloxacin controlled, multicentre, international, prospective study.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Prulifloxacin 600 mgPrulifloxacin 600 mg |
| Group 2 | Active comparator | Drug: Levofloxacin 500mgLevofloxacin 500 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male between 18 and 50 years of age (limited included) with no limitation of race.
- Patients presenting symptoms of prostatitis for at least 3 months.
- Laboratory evidence of CBP at Visit 0 (Screening), assessed by
- Medications for chronic prostatitis and/or medications that may affect bladder or prostate function (including but not limited to hormone therapy, anticholinergic or alpha blocker) must be discontinued at least 7 days before study drug intake.
- Patients legally capable to give their consent to participate the study, and available to sign and date the written informed consent.
Key exclusion criteria (25 listed)
- Known hypersensitivity or allergy to antibacterial fluoroquinolones or to any components of the study medications.
- Pathogen/s resistant to the study drugs at Visit 0 (Screening).
- Suspicion for prostatic cancer, neurogenic bladder, Benign Prostatic Hypertrophy (BPH), bladder neck obstruction or urethral stricture.
- Body Mass Index (BMI) < 16 kg/m^2.
- Immunocompromised patients.
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 |
|---|---|---|
| Prulifloxacin 600 mgAlso: Unidrox®Oral administration of one tablet once daily for 28 days of prulifloxacin 600 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium. | Drug | Group 1 |
| Levofloxacin 500mgAlso: Levoxacin®Oral administration of one tablet once daily for 28 days of levofloxacin 500 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium. | Drug | Group 2 |
Primary outcome
Eradication of bacterial growth
Time frame: 7 days after the EOT
Eradication defined as absence of bacterial growth as <10^2 CFU/ml in voided bladder 3 (VB3) or expressed prostatic secretion (EPS) after 7 days from the End Of Treatment (EOT).
6 secondary outcomes
Eradication of bacterial growth
Time frame: 3 months after the EOT
Eradication of bacterial growth
Time frame: 6 months after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Time frame: Screening - 7 days after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Time frame: Screening - 3 months after the EOT
Reduction in National Institute of Health - Chronic Prostatitis Symptom (NIH-CPSI)
Time frame: Screening - 6 months after the EOT
Frequency of treatment-related adverse events
Time frame: 6 months
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 May 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prulifloxacin 600 mg and Levofloxacin 500mg in people with Chronic Bacterial Prostatitis, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 11 sites in 2 countries.
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 8 inclusion and 25 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 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy, Greece. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Eradication of bacterial growth (time frame: 7 days after the EOT). 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 May 2021.