Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections
- Registration Number
- NCT00669994
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 180
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Ciprofloxacin -
- Primary Outcome Measures
Name Time Method Bacteriologic outcome in patients with UTI caused by S. saprophyticus 4-11 days post-treatment
- Secondary Outcome Measures
Name Time Method Adverse Events Collection Up to 4-11 days post-treatment Clinical Response 4-11 days post-treatment Incidence of premature terminations Premature discontinuation