Urinary Tract Infection
Conditions
Keywords
UTI, Urinary Tract Infection
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.
Interventions
DRUGCiprofloxacin
Cipro XR 500 mg tablets taken once daily
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacteriologic outcome in patients with UTI caused by S. saprophyticus | 4-11 days post-treatment |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events Collection | Up to 4-11 days post-treatment |
| Clinical Response | 4-11 days post-treatment |
| Incidence of premature terminations | Premature discontinuation |
Countries
United States
Outcome results
None listed