Urinary Tract InfectionsPhase 3NCT00258089
A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections
A Phase 3 study testing Levofloxacin in people with Urinary Tract Infections and Bacteriuria, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an antibiotic) with that of oral ciprofloxacin in the treatment of complicated urinary tract infections in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Bacteriuria, Urologic Diseases
- What is being tested?
- Levofloxacin
- How many people
- 578 participants
- Where
- No sites listed yet
- Study dates
- Jun 1993to Jan 1995
- 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
- Diagnosis of a urinary tract infection with complicating factors such as anatomical or functional abnormalities
- capable of taking medication by mouth
- previous antibacterial therapy of less than 24 hours, or previous antibacterial therapy of greater than 24 hours that did not eliminate or stabilize the infection.
Who cannot join
- Patients having any medical condition that requires antimicrobial therapy to be given intravenously or by hypodermic needle
- complete obstruction of any part of the urinary tract
- inflammation of the prostate gland
- previous allergic or serious adverse reaction to similar antibiotics
- pregnant or nursing females, or those lacking adequate contraception.
About this study
Official title: A Multicenter, Double-Blind, Randomized Study To Compare The Safety And Efficacy Of Oral Levofloxacin With That Of Ciprofloxacin HCl In The Treatment Of Complicated Urinary Tract Infections In Adults
The purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an antibiotic) with that of oral ciprofloxacin in the treatment of complicated urinary tract infections in adults.
Read the detailed description
Levofloxacin is an antibacterial agent used for the treatment of a many types of acute infections in adults. This is a randomized, double-blind study of the safety and effectiveness of levofloxacin compared with ciprofloxacin in the treatment of adults with a complicated urinary tract infection. Complicated urinary tract infections include those associated with fever, chills, kidney involvement or anatomic and functional abnormalities of the bladder. Patients in one group are treated with 250 mg of levofloxacin taken once daily for 10 days, and the other group is treated with 500 mg of ciprofloxacin, also an antibacterial agent, taken twice daily for 10 days. Patients are followed for 5 to 9 days after completion of treatment (post-therapy) to assess clinical signs and symptoms of infection. Long-term follow up (4 to 6 weeks after the end of treatment) of those patients who respond to therapy provides further evaluation of clinical signs and symptoms. The primary assessments of effectiveness include the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of the study) and the clinical response (the resolution of signs and symptoms at post-therapy compared with those at the start of the study). An additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy. The study hypothesis is that levofloxacin is at least as effective therapeutically and as well tolerated as ciprofloxacin in the treatment of adults with complicated urinary tract infections. Two levofloxacin 125 mg tablets taken orally once daily (and two placebo tablets taken once daily, 12 hours later) for 10 days; or one ciprofloxacin 500 mg tablet and one placebo tablet taken orally twice daily for 10 days.
- Conditions
- Urinary Tract Infections, Bacteriuria, Urologic Diseases, Pyelonephritis, Neurogenic Bladder
- Being tested
- Levofloxacin
- Keywords
- levofloxacin, urinary tract infections, bacterial infections, bacteriuria, urinary anti-infective agents, urinary infections, quinolones
- Medical subject headings
- Urinary Tract Infections, Bacteriuria, Urologic Diseases, Pyelonephritis, Urinary Bladder, Neurogenic, Bacterial Infections
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.
Clinical response, the resolution of signs and symptoms at post-therapy compared with those at the start of study; Microbiological response, the eradication at post-therapy of infectious organism identified at start of study.
Secondary outcomes (1)
Overall clinical response (described as cured, improved or failed) at long-term follow up; incidence of adverse events throughout the study; change in clinical laboratory tests and physical examinations from start of study to post-therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2005 (estimated)
- Study startJun 1993
- Study completionJan 1995
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258089
- Sponsor's protocol ID
- CR005482
- Status last verified
- Nov 2010
- First submitted
- 22 Nov 2005
- Last updated
- 23 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized Study To Compare The Safety And Efficacy Of Oral Levofloxacin With That Of Ciprofloxacin HCl In The Treatment Of Complicated Urinary Tract Infections In Adults
- ClinicalTrials.gov ID
- NCT00258089
- Acronym / sponsor ID
- CR005482
- Conditions
- Urinary Tract Infections, Bacteriuria, Urologic Diseases, Pyelonephritis, Neurogenic Bladder
- Keywords
- levofloxacin, urinary tract infections, bacterial infections, bacteriuria, urinary anti-infective agents, urinary infections, quinolones
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Study start
- Jun 1993
- Study completion
- Jan 1995 (actual)
- First posted
- 24 Nov 2005 (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 the study is to compare the safety and effectiveness of oral levofloxacin (an antibiotic) with that of oral ciprofloxacin in the treatment of complicated urinary tract infections in adults.
Detailed description
Levofloxacin is an antibacterial agent used for the treatment of a many types of acute infections in adults. This is a randomized, double-blind study of the safety and effectiveness of levofloxacin compared with ciprofloxacin in the treatment of adults with a complicated urinary tract infection. Complicated urinary tract infections include those associated with fever, chills, kidney involvement or anatomic and functional abnormalities of the bladder. Patients in one group are treated with 250 mg of levofloxacin taken once daily for 10 days, and the other group is treated with 500 mg of ciprofloxacin, also an antibacterial agent, taken twice daily for 10 days. Patients are followed for 5 to 9 days after completion of treatment (post-therapy) to assess clinical signs and symptoms of infection. Long-term follow up (4 to 6 weeks after the end of treatment) of those patients who respond to therapy provides further evaluation of clinical signs and symptoms. The primary assessments of effectiveness include the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of the study) and the clinical response (the resolution of signs and symptoms at post-therapy compared with those at the start of the study). An additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy. The study hypothesis is that levofloxacin is at least as effective therapeutically and as well tolerated as ciprofloxacin in the treatment of adults with complicated urinary tract infections. Two levofloxacin 125 mg tablets taken orally once daily (and two placebo tablets taken once daily, 12 hours later) for 10 days; or one ciprofloxacin 500 mg tablet and one placebo tablet taken orally twice daily for 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of a urinary tract infection with complicating factors such as anatomical or functional abnormalities
- capable of taking medication by mouth
- previous antibacterial therapy of less than 24 hours, or previous antibacterial therapy of greater than 24 hours that did not eliminate or stabilize the infection.
Key exclusion criteria (5 listed)
- Patients having any medical condition that requires antimicrobial therapy to be given intravenously or by hypodermic needle
- complete obstruction of any part of the urinary tract
- inflammation of the prostate gland
- previous allergic or serious adverse reaction to similar antibiotics
- pregnant or nursing females, or those lacking adequate contraception.
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
Clinical response, the resolution of signs and symptoms at post-therapy compared with those at the start of study; Microbiological response, the eradication at post-therapy of infectious organism identified at start of study.
1 secondary outcome
Overall clinical response (described as cured, improved or failed) at long-term follow up; incidence of adverse events throughout the study; change in clinical laboratory tests and physical examinations from start of study to post-therapy.
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 23 May 2011.
- A study of the safety and effectiveness of oral levofloxacin compared with oral ciprofloxacin in the treatment of complicated urinary tract infectionsLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levofloxacin in people with Urinary Tract Infections and Bacteriuria, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 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 23 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical response, the resolution of signs and symptoms at post-therapy compared with those at the start of study; Microbiological response, the eradication at post-therapy of infectious organism identified at start of study.. 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 23 May 2011.