Urinary Tract InfectionPhase 3EMERONNCT00668122
Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections
A Phase 3 study testing Cipro XR (Ciprofloxacin, BAYQ3939) and Cipro IR (Ciprofloxacin, BAYQ3939) in people with Urinary Tract Infection, run by Bayer at 38 sites in Italy.
Trial summary
To assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR) tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet 500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial urinary tract infections (cUTI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Cipro XR (Ciprofloxacin, BAYQ3939) and Cipro IR (Ciprofloxacin, BAYQ3939)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 38 sitesItaly
- Study dates
- Mar 2004to Jan 2006
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The primary diagnosis in this clinical trial was cUTI in men or non-pregnant women over 18 years of age. Other main inclusion criteria:
- One or more clinical symptoms and signs of a lower UTI: fever (> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation.
- One or more of the following underlying conditions suggestive of cUTI:
- Indwelling urinary catheter.
- 100 mL of residual urine after voiding.
- Neurogenic bladder.
- Obstructive uropathy due to lithiasis, tumor or fibrosis.
- Acute urinary retention in men.
Who cannot join
- Diagnosis of pyelonephritis supported by clinical signs/symptoms of fever (>38°C orally), chills and flank pain (all 3 signs/symptoms must be present).
- Have a history of allergy to quinolones
- Are unable to take oral medication
- Have an intractable infection requiring > 14 days of therapy
- Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium
- Have prostatitis or epididymitis
Show all 12Show fewer
- Have had a renal transplant
- Have ileal loop or vesica- urethral reflux
- Have significant liver or kidney impairment
- Have a history of tendinopathy associated with fluoroquinolones
- Are pregnant, nursing
- Have a history of convulsions or CNS disorders
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Italy38 sites
Study site
Alessandria, 15100
Study site
Bari, 70124
Study site
Bassano del Grappa, Vicenza, 36061
Study site
Benevento, 82100
Study site
Bergamo, 24125
Study site
Bologna, 40138
Study site
Busto Arsizio, Varese, 21052
Study site
Camposampiero, Padova, 35012
Study site
Caserta, 81100
Study site
Catania, 95124
Study site
Chieti, 66100
Study site
Florence, 50139
Study site
Frosinone, 03100
Study site
Genova, 16132
Study site
Genova, 16149
Study site
L’Aquila, 67100
Study site
Mantua, 46100
Study site
Massa Carrara, 54100
Study site
Messina, 98165
Study site
Milan, 20132
Study site
Monza, Milano, 20052
Study site
Naples, 80131
Study site
Orbassano, Torino, 10043
Study site
Palermo, 90129
Study site
Perugia, 06122
Study site
Potenza, 85100
Study site
Reggio Calabria, 89124
Study site
Reggio Emilia, 42100
Study site
Rimini, 47900
Study site
Roma, 00144
Study site
Roma, 00155
Study site
Roma, 00168
Study site
Sassari, 07100
Study site
Syracuse, 96100
Study site
Torino, 10154
Study site
Trieste, 34149
Study site
Varese, 21100
Study site
Verona, 37136
About this study
Official title: Efficacy and Safety of Ciprofloxacin Extended-Release 1000 mg Once-Daily Versus Ciprofloxacin Immediate-Release 500 mg Twice-Daily Given 7-14 Days in Patients With Complicated Urinary Tract Infections: Prospective, Randomized, Double-Blind Trial.
To assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR) tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet 500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial urinary tract infections (cUTI).
- Conditions
- Urinary Tract Infection
- Being tested
- Cipro XR (Ciprofloxacin, BAYQ3939), Cipro IR (Ciprofloxacin, BAYQ3939)
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cipro XR (Ciprofloxacin, BAYQ3939)Drug
Ciprofloxacin XR 1000 mg orally once a day
Cipro IR (Ciprofloxacin, BAYQ3939)Drug
Ciprofloxacin IR 500 mg orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Cipro XR (Ciprofloxacin, BAYQ3939) |
| Arm 2 | Experimental | Not described Receives: Drug: Cipro IR (Ciprofloxacin, BAYQ3939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).
Measured: 5-9 days
Secondary outcomes (6)
Bacteriological outcome during treatment
Measured: 7-14 days
Bacteriological outcome at follow-up
Measured: 28-42 days
Clinical outcome during treatment
Measured: 7-14 days
Clinical outcome at the test-of-cure visit
Measured: 5-9 days
Clinical outcome at follow-up
Measured: 28-42 days
Adverse event collection
Measured: 28-42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startMar 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668122
- Sponsor's protocol ID
- 11454
- Acronym
- EMERON
- Status last verified
- Jun 2009
- First submitted
- 24 Apr 2008
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ciprofloxacin Extended-Release 1000 mg Once-Daily Versus Ciprofloxacin Immediate-Release 500 mg Twice-Daily Given 7-14 Days in Patients With Complicated Urinary Tract Infections: Prospective, Randomized, Double-Blind Trial.
- ClinicalTrials.gov ID
- NCT00668122
- Acronym / sponsor ID
- EMERON / 11454
- Conditions
- Urinary Tract Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Jan 2006 (actual)
- First posted
- 28 Apr 2008 (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.
To assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR) tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet 500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial urinary tract infections (cUTI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Cipro XR (Ciprofloxacin, BAYQ3939) |
| Arm 2 | Experimental | Drug: Cipro IR (Ciprofloxacin, BAYQ3939) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The primary diagnosis in this clinical trial was cUTI in men or non-pregnant women over 18 years of age. Other main inclusion criteria:
- One or more clinical symptoms and signs of a lower UTI: fever (> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation.
- One or more of the following underlying conditions suggestive of cUTI:
- Indwelling urinary catheter.
- 100 mL of residual urine after voiding.
Key exclusion criteria (12 listed)
- Diagnosis of pyelonephritis supported by clinical signs/symptoms of fever (>38°C orally), chills and flank pain (all 3 signs/symptoms must be present).
- Have a history of allergy to quinolones
- Are unable to take oral medication
- Have an intractable infection requiring > 14 days of therapy
- Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium
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 |
|---|---|---|
| Cipro XR (Ciprofloxacin, BAYQ3939)Ciprofloxacin XR 1000 mg orally once a day | Drug | Arm 1 |
| Cipro IR (Ciprofloxacin, BAYQ3939)Ciprofloxacin IR 500 mg orally twice a day | Drug | Arm 2 |
Primary outcome
Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).
Time frame: 5-9 days
6 secondary outcomes
Bacteriological outcome during treatment
Time frame: 7-14 days
Bacteriological outcome at follow-up
Time frame: 28-42 days
Clinical outcome during treatment
Time frame: 7-14 days
Clinical outcome at the test-of-cure visit
Time frame: 5-9 days
Clinical outcome at follow-up
Time frame: 28-42 days
Adverse event collection
Time frame: 28-42 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 30 Jun 2009.
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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.
Bayer Study Director study director
Bayer
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cipro XR (Ciprofloxacin, BAYQ3939) and Cipro IR (Ciprofloxacin, BAYQ3939) in people with Urinary Tract Infection, run by Bayer at 38 sites in Italy.
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 12 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 30 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Italy. 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?
Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit). (time frame: 5-9 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 30 Jun 2009.