A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00210886 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : June 10, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Tract Infections Pyelonephritis | Drug: levofloxacin | Phase 3 |
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 |

- Combination of clinical success and microbiologic eradication (known as therapeutic response) at post-therapy visit.
- By patient and pathogen microbiologic and clinical responses at the post-therapy and post-study visits.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00210886 |
Other Study ID Numbers: |
CR004705 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | June 10, 2011 |
Last Verified: | April 2010 |
complicated urinary tract infection urinary tract infection acute pyelonephritis |
pyelonephritis kidney infection bladder infection |
Infections Communicable Diseases Urinary Tract Infections Pyelonephritis Disease Attributes Pathologic Processes Urologic Diseases Nephritis, Interstitial Nephritis Kidney Diseases Pyelitis Levofloxacin |
Ofloxacin 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 |