Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections

Condition(s) targeted: Urinary Tract Infection

Intervention: Ciprofloxacin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

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

This trial evaluated how effective and safe Cipro XR was in treating female patients with signs and symptoms of a lower urinary tract infections. After 3 days of treatment, patients were evaluated to determine if signs/symptoms disappeared and the infecting bacteria was eliminated.

Official title: Prospective, Open Label Non-Comparative, Multi-Center Trial to Evaluate the Efficacy and Safety of Cipro® XR 500 mg Once Daily for 3 Days in Treating Female Patients With Acute, Uncomplicated, Symptomatic Lower Urinary Tract Infections

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Bacteriologic outcome in patients with UTI caused by S. saphrophyticus

Secondary outcome:

Adverse Events

Clinical Response

Incidence of premature terminations

Minimum age: 18 Years. Maximum age: 44 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Non-pregnant, non-lactating female outpatients between the ages of 18 - 44 years

(inclusive)

- Patients with at least two of the following clinical signs and symptoms of an uUTI:

- Dysuria

- Frequency

- Urgency

- Suprapubic pain

- Patients with onset of symptoms < 72 hours prior to study entry

- Patients with one positive pre-treatment clean-catch midstream urine culture at

enrollment in the study, defined as > 10000 CFU/mL (study drug treatment is permitted prior to the availability of urine culture results)

- Positive leukocyte esterase (LE) (1+ or greater) utilizing a urine dipstick method of

analysis

- Patients willing to give written informed consent

- Cultures must be performed on pre-treatment clean-catch midstream urine (MSU)

specimens

Exclusion Criteria:

- Males

- Women who are pregnant, nursing, or not using two medically accepted, effective

methods of birth control

- Patients with known or suspected hypersensitivity to quinolones

- Patients unable to take oral medication for any reason

- Patients with an asymptomatic bacteriuria

- Patients with complicated UTI, defined as: a clinical syndrome characterized by the

development of systemic and local signs and symptoms of fever (>= 38. 3°C/101°F orally), chills, malaise, flank pain, back pain, or costovertebral angle (CVA) pain or tenderness

- Symptoms as outlined in the inclusion criteria, Section 4. 2.1, occurring in the

presence of a functional or anatomical abnormality of the urinary tract or in the presence of urinary catheterization

- Patients with symptoms of a UTI within the 4 weeks prior to the present episode

- Patients with the onset of symptoms >72 hours prior to study entry

- Patients with three or more episodes of any UTI in the past 12 months

- Patients with evidence of factors predisposing to the development of UTIs, including

calculi, stricture, primary renal disease (e. g. polycystic renal disease), or neurogenic bladder

- Patients who received systemic antimicrobial therapy within 48 hours prior to entry

- Patients with a neutrophil count < 1000/mm3, CD4 < 200/mm3 or other conditions

associated with significant depression in host defense; HIV testing is not mandatory

- Patients requiring concomitant systemic antibacterial therapy with agents not

specified in this protocol

- Patients with a previous history of tendinopathy associated with fluoroquinolones

- Patients diagnosed with a rapidly fatal underlying disease (death expected within six

months)

- Patients requiring concomitant use of theophylline

- Patients previously enrolled in this clinical study

- Patients taking an investigational drug in the last 30 days

Pelham, Alabama 35124, United States

Birmingham, Alabama 35242, United States

Birmingham, Alabama 35205, United States

Phoenix, Arizona 85023, United States

Sylmar, California 91342, United States

San Diego, California 92182-4701, United States

San Luis Obispo, California 93401, United States

Laguna Hills, California 92653, United States

Yorba Linda, California 92886, United States

Avon, Connecticut 06001, United States

Clearwater, Florida 33761, United States

Pembroke Pines, Florida 33024, United States

Evansville, Indiana 47714, United States

Milford, Massachusetts 01757, United States

Royal Oak, Michigan 48073-6769, United States

Elizabeth, New Jersey 07202-3672, United States

Holmdel, New Jersey 07733, United States

Camillus, New York 13031, United States

Beaver, Pennsylvania 15009, United States

Feasterville, Pennsylvania 19053, United States

Hatboro, Pennsylvania 19040, United States

Summerville, South Carolina 29485, United States

San Antonio, Texas 78209, United States

Murray, Utah 84107, United States

Salt Lake City, Utah 84121, United States

Salt Lake City, Utah 84109, United States

Salt Lake City, Utah 84102, United States

West Jordan, Utah 84088, United States

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Starting date: July 2003
Ending date: October 2003
Last updated: April 29, 2008