Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections

Urinary Tract Infection Clinical Trial

— EMERON  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668122
• Other study ID #: 11454
• Status: Completed
• Phase: Phase 3
• First received: April 24, 2008
• Last updated: June 29, 2009
• Start date: March 2004
• Est. completion date: January 2006

Study information

• Verified date: June 2009
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Cipro XR (Ciprofloxacin, BAYQ3939)
Ciprofloxacin XR 1000 mg orally once a day
• Cipro IR (Ciprofloxacin, BAYQ3939)
Ciprofloxacin IR 500 mg orally twice a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).		5-9 days	No
Secondary	Bacteriological outcome during treatment		7-14 days	No
Secondary	Bacteriological outcome at follow-up		28-42 days	No
Secondary	Clinical outcome during treatment		7-14 days	No
Secondary	Clinical outcome at the test-of-cure visit		5-9 days	No
Secondary	Clinical outcome at follow-up		28-42 days	No
Secondary	Adverse event collection		28-42 days	No

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