A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.
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| ClinicalTrials.gov Identifier: NCT00210886 |
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Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : June 10, 2011
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Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of two antibiotics in the treatment of complicated urinary tract infection or acute pyelonephritis (kidney infection). A 5-day course of 750 milligrams of levofloxacin given intravenously and/or by mouth once daily will be compared to a 10-day course of 400 milligrams of ciprofloxacin given intravenously and/or 500 milligrams of ciprofloxacin given by mouth twice daily.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urinary Tract Infections Pyelonephritis | Drug: levofloxacin | Phase 3 |
Levofloxacin has been approved in both its oral and intravenous forms to treat a large number of infections caused by bacteria. Levofloxacin and other members of a class of antibiotics known as fluoroquinolones have been used successfully to treat urinary and kidney infections. This study will compare the effectiveness and safety of levofloxacin given for 5 days to that of another fluoroquinolone, ciprofloxacin, given for 10 days in treating complicated urinary tract infection or acute pyelonephritis (kidney infection). A shorter course of antibiotics may help patients take all of their medication, which is critically important for curing the infection. A shorter course may also help prevent the development of bacteria that cannot be killed by antibiotics. Patients will take 750 milligrams of levofloxacin intravenously and/or by mouth once daily for 5 days or 400 milligrams of ciprofloxacin intravenously and/or 500 milligrams of ciprofloxacin by mouth twice daily for 10 days. To prevent the study doctor, study staff and patients from knowing which study drug they are taking, all study drug will manufactured to look the same and patients on the 5-day regimen will be given placebo for the last 5 days of their participation in the study. The intravenous infusion bags will be covered so that the solution cannot be seen. The objective of the study is to demonstrate that 5 days of levofloxacin once daily is at least as effective as 10 days of ciprofloxacin twice daily in treating complicated urinary tract infection or acute pyelonephritis. Patients will take 750 milligrams of levofloxacin intravenously and/or by mouth once daily for 5 days or 400 milligrams of ciprofloxacin intravenously and/or 500 milligrams of ciprofloxacin by mouth twice daily for 10 days.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1109 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Double-blind, Randomized Study to Compare the Efficacy and Safety of Levofloxacin 750 mg Once Daily for Five Days Versus Ciprofloxacin Twice Daily for Ten Days in the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis. |
| Study Start Date : | October 2004 |
| Actual Study Completion Date : | April 2006 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Urinary Tract Infections
Primary Outcome Measures :
- Combination of clinical success and microbiologic eradication (known as therapeutic response) at post-therapy visit.
Secondary Outcome Measures :
- By patient and pathogen microbiologic and clinical responses at the post-therapy and post-study visits.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Positive dipstick test for leukocyte esterase AND/OR at least 5 white blood cells per centrifuged urine sediment AND/OR at least 10 white blood cells per microliter of uncentrifuged urine
- outpatient or inpatient (in hospital, nursing home, or other extended-care facility)
- clinical diagnosis of either complicated urinary tract infection or acute pyelonephritis.
Exclusion Criteria:
- Allergy or serious adverse reaction to levofloxacin, ciprofloxacin, or other fluoroquinolone
- urinary tract surgery or lithotripsy (treatment for kidney stones) within 7 days before study entry
- a second coexisting bacterial infection that requires systemic antibiotics
- need for a second antibiotic to treat the urinary tract infection
- obstruction of the urinary tract
- prostate infection.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210886
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00210886 History of Changes |
| Other Study ID Numbers: |
CR004705 |
| First Posted: | September 21, 2005 Key Record Dates |
| Last Update Posted: | June 10, 2011 |
| Last Verified: | April 2010 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
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complicated urinary tract infection urinary tract infection acute pyelonephritis |
pyelonephritis kidney infection bladder infection |
Additional relevant MeSH terms:
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Infection Communicable Diseases Urinary Tract Infections Pyelonephritis Urologic Diseases Nephritis, Interstitial Nephritis Kidney Diseases Pyelitis Levofloxacin Ofloxacin Ciprofloxacin |
Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Anti-Bacterial Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors |