Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00668122

Purpose

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).

Condition	Intervention	Phase
Urinary Tract Infection	Drug: Cipro XR (Ciprofloxacin, BAYQ3939) Drug: Cipro IR (Ciprofloxacin, BAYQ3939)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy 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.

Resource links provided by NLM:

MedlinePlus related topics: Urinary Tract Infections

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit). [ Time Frame: 5-9 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bacteriological outcome during treatment [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
Bacteriological outcome at follow-up [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]
Clinical outcome during treatment [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
Clinical outcome at the test-of-cure visit [ Time Frame: 5-9 days ] [ Designated as safety issue: No ]
Clinical outcome at follow-up [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]
Adverse event collection [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]

Enrollment:	212
Study Start Date:	March 2004
Study Completion Date:	January 2006

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Cipro XR (Ciprofloxacin, BAYQ3939) Ciprofloxacin XR 1000 mg orally once a day
Arm 2: Experimental	Drug: Cipro IR (Ciprofloxacin, BAYQ3939) Ciprofloxacin IR 500 mg orally twice a day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668122

Show 39 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	11454
Study First Received:	April 24, 2008
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00668122 History of Changes
Health Authority:	Italy: The Italian Medicines Agency

Additional relevant MeSH terms:

Anti-Infective Agents
Ciprofloxacin
Communicable Diseases
Molecular Mechanisms of Pharmacological Action
Urologic Diseases
Therapeutic Uses

Urinary Tract Infections
Enzyme Inhibitors
Infection
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 22, 2009