ProstatitisPhase 3NCT00277511
Levofloxacin, Chronic Bacterial Prostatitis
A Phase 3 study testing Levofloxacin in people with Prostatitis, run by Sanofi at 1 site in Germany.
Trial summary
Primary objective: To investigate the microbiological efficacy, assessed as eradication rate based on microbiologically evaluable patients 1 month post treatment with oral Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category II) Secondary objectives: To investigate the microbiological… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatitis
- What is being tested?
- Levofloxacin
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2003to not given
- Phase
- Phase 3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following criteria will be considered for enrollment into the study:
- A clinical diagnosis of chronic prostatitis as evidenced by the following criteria:
- clinical signs and symptoms of prostatitis and
- a history of chronic prostatitis as defined as: symptomatic prostatitis (a clinical diagnosis of prostatitis having been made for at least one previous episode which episode having lasted four weeks or two or more other episodes during the previous twelve months) and leucocyturia greater/equal 10 WBC/HPF x 400
- Laboratory evidence of prostatitis
- Candidate is appropriate for oral therapy.
- OTC medications for chronic prostatitis (other than antibiotics), which the subject has been receiving must continue throughout the study at the same dose or be discontinued prior to study entry.
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- Need for parenteral therapy for the treatment of chronic bacterial prostatitis (CBP, Category II)
- Subjects with pathogen known or suspected to be resistant to the study drug
- Requirement for a second systemic antibacterial regimen
- Any condition which may interfere with the evaluation of the study drug including transurethral prostatectomy within 6 months of enrollment, the presence of a permanent transurethral catheter or a history of cystostomy or nephrostomy
- Taking medication that may effect bladder or prostate function (e.g. hormone therapy anticholinergics or alpha-blocker)
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- Patients not receiving saw palmetto at the time of study entry should not start treatment with saw palmetto within 10 weeks of study entry
- Known prostatic carcinoma
- The presence of another infection requiring therapy with an antibacterial other than the study drug
- Greater than 24 hours of potentially effective therapy within seven days prior to study when there is documented evidence of a resistant organism or clinical failure after five or more days of previous antibacterial therapy
- History of hypersensitivity to the investigational product or to drugs with similar chemical structures
- History of tendonitis or tendon rupture
- Treatment with other quinolones in the last 14 days before study entry
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
- Treatment with any investigational product in the last 30 days before study entry
- Clinically relevant cardiovascular, hepatic, neurologic, endocrine or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
- History of drug or alcohol abuse
- Impaired hepatic function, as shown by:
- AST (SGOT) greater/equal 3 times the upper limit of the reference range
- ALT (SGPT) greater/equal 3 times the upper limit of the reference range
- bilirubin greater 51 µmol/l, i.e., greater 3 mg/dl (except of Gilbert disease)
- hepatic encephalopathy
- Impaired renal function, as shown by either creatinine clearance smaller 50 ml/min or undergoing hemodialysis or peritoneal dialysis (creatinine clearance may be estimated by formula or nomogram)
- Underweight (40 kg or less)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multinational, Multicenter, Non-Comparative, Open Study With a 6 Months Follow-up Period to Demonstrate the Efficacy and Safety of Oral Levofloxacin 500 mg Once Daily in the Treatment of Chronic Bacterial Prostatitis (CBP)
Primary objective:
- To investigate the microbiological efficacy, assessed as eradication rate based on microbiologically evaluable patients 1 month post treatment with oral Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category II)
Read more
Secondary objectives:
- To investigate the microbiological efficacy, assessed as eradication rate based on microbiologically evaluable patients 6 months post treatment with oral Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category II).
- To assess the clinical response rate based on resolution of signs and symptoms after 2 weeks of treatment; 5-12 days, 1 month, 3 months and 6 months post treatment with oral Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category II).
- To assess the safety of Levofloxacin 500 mg on the basis of adverse events, standard clinical chemistry, hematology, urinalysis and vital signs in male adults with chronic bacterial prostatitis (CBP, category II).
- Conditions
- Prostatitis
- Being tested
- Levofloxacin
- Medical subject headings
- Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy data will be determined by eradication rate based on microbiologically evaluable subjects, evaluated for each pathogen and subject.
Measured: determined at 1 month follow-up
Secondary outcomes (2)
Secondary efficacy data will be determined by microbiological eradication rate
Measured: at 6 months follow-up
clinical response rate based on resolution of signs and symptoms
Measured: after 2 weeks of treatment and during follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Katrin Roscher, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277511
- Sponsor's protocol ID
- HR355/3036
- Status last verified
- Oct 2007
- First submitted
- 13 Jan 2006
- Last updated
- 12 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multinational, Multicenter, Non-Comparative, Open Study With a 6 Months Follow-up Period to Demonstrate the Efficacy and Safety of Oral Levofloxacin 500 mg Once Daily in the Treatment of Chronic Bacterial Prostatitis (CBP)
- ClinicalTrials.gov ID
- NCT00277511
- Acronym / sponsor ID
- HR355/3036
- Conditions
- Prostatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- First posted
- 16 Jan 2006 (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.
Primary objective:
- To investigate the microbiological efficacy, assessed as eradication rate based on microbiologically evaluable patients 1 month post treatment with oral Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category II)
Secondary objectives:
- To investigate the microbiological efficacy, assessed as eradication rate based on microbiologically evaluable patients 6 months post treatment with oral Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category II).
- To assess the clinical response rate based on resolution of signs and symptoms after 2 weeks of treatment; 5-12 days, 1 month, 3 months and 6 months post treatment with oral Levofloxacin 500 mg in male adults with chronic bacterial prostatitis (CBP, category II).
- To assess the safety of Levofloxacin 500 mg on the basis of adverse events, standard clinical chemistry, hematology, urinalysis and vital signs in male adults with chronic bacterial prostatitis (CBP, category II).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects meeting all of the following criteria will be considered for enrollment into the study:
- A clinical diagnosis of chronic prostatitis as evidenced by the following criteria:
- Laboratory evidence of prostatitis
- Candidate is appropriate for oral therapy.
- OTC medications for chronic prostatitis (other than antibiotics), which the subject has been receiving must continue throughout the study at the same dose or be discontinued prior to study entry.
Key exclusion criteria (24 listed)
- Need for parenteral therapy for the treatment of chronic bacterial prostatitis (CBP, Category II)
- Subjects with pathogen known or suspected to be resistant to the study drug
- Requirement for a second systemic antibacterial regimen
- Any condition which may interfere with the evaluation of the study drug including transurethral prostatectomy within 6 months of enrollment, the presence of a permanent transurethral catheter or a history of cystostomy or nephrostomy
- Taking medication that may effect bladder or prostate function (e.g. hormone therapy anticholinergics or alpha-blocker)
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 |
|---|---|---|
| Levofloxacin | Drug | – |
Primary outcome
Primary efficacy data will be determined by eradication rate based on microbiologically evaluable subjects, evaluated for each pathogen and subject.
Time frame: determined at 1 month follow-up
2 secondary outcomes
Secondary efficacy data will be determined by microbiological eradication rate
Time frame: at 6 months follow-up
clinical response rate based on resolution of signs and symptoms
Time frame: after 2 weeks of treatment and during follow-up period.
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 12 Oct 2007.
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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.
Katrin Roscher study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levofloxacin in people with Prostatitis, run by Sanofi at 1 site in Germany.
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 7 inclusion and 24 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 12 Oct 2007. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Primary efficacy data will be determined by eradication rate based on microbiologically evaluable subjects, evaluated for each pathogen and subject. (time frame: determined at 1 month follow-up). 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 12 Oct 2007.