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

Bayer

Status and phase

Completed

Phase 4

Conditions

Urinary Tract Infection

Treatments

Drug: Ciprofloxacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00669994

100546

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

Female

Ages

18 to 44 years old

Volunteers

No Healthy Volunteers

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