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

Condition(s) targeted: Urinary Tract Infection

Intervention: Cipro XR (Ciprofloxacin, BAYQ3939) (Drug); Cipro IR (Ciprofloxacin, BAYQ3939) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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).

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.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy variable was the bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).

Secondary outcome:

Bacteriological outcome during treatment

Bacteriological outcome at follow-up

Clinical outcome during treatment

Clinical outcome at the test-of-cure visit

Clinical outcome at follow-up

Safety

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 (> 38oC, 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 (>38oC 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

Napoli 80131, Italy

Alessandria 15100, Italy

Bari 70124, Italy

Benevento 82100, Italy

Bergamo 24125, Italy

Catania 95124, Italy

Firenze 50139, Italy

L'Aquila 67100, Italy

Mantova 46100, Italy

Messina 98165, Italy

Milano 20132, Italy

Palermo 90129, Italy

Perugia 06122, Italy

Potenza 85100, Italy

Reggio Calabria 89124, Italy

Reggio Emilia 42100, Italy

Roma 00155, Italy

Roma 00144, Italy

Roma 00168, Italy

Genova 16149, Italy

Siracusa 96100, Italy

Torino 10154, Italy

Trieste 34149, Italy

Verona 37126, Italy

Caserta 81100, Italy

Bologna 40138, Italy

Monza, Milano 20052, Italy

Orbassano, Torino 10043, Italy

Bassano del Grappa, Vicenza 36061, Italy

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Starting date: March 2004
Ending date: January 2006
Last updated: April 27, 2008