Clinical trial NCT00669994: Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infection
Keywords: UTI
Urinary Tract Infection
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-05-01
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 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

Primary outcomes:
measure: Bacteriologic outcome in patients with UTI caused by S. saprophyticus
timeFrame: 4-11 days post-treatment
Secondary outcomes:
measure: Adverse Events Collection
timeFrame: Up to 4-11 days post-treatment
measure: Clinical Response
timeFrame: 4-11 days post-treatment
measure: Incidence of premature terminations
timeFrame: Premature discontinuation
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Pelham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Laguna Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Yorba Linda
country: United States
state: California
city: Avon
country: United States
state: Connecticut
city: Clearwater
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Evansville
country: United States
state: Indiana
city: Milford
country: United States
state: Massachusetts
city: Royal Oak
country: United States
state: Michigan
city: Elizabeth
country: United States
state: New Jersey
city: Holmdel
country: United States
state: New Jersey
city: Camillus
country: United States
state: New York
city: Beaver
country: United States
state: Pennsylvania
city: Feasterville
country: United States
state: Pennsylvania
city: Hatboro
country: United States
state: Pennsylvania
city: Summerville
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: