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

Completed · Phase 4

Conditions studied: Urinary Tract Infection

In brief

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.

Key facts

Study ID

NCT00669994

Run by

Bayer

People needed

180

Starts

2003-07-01

Expected to finish

2003-10-01

Last updated by the study team

2014-12-19

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Pelham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Laguna Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — San Diego, California, United States
• Study site — San Luis Obispo, California, United States
• Study site — San Mateo, California, United States
• Study site — Sylmar, California, United States
• Study site — Yorba Linda, California, United States
• Study site — Avon, Connecticut, United States
• Study site — Clearwater, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Evansville, Indiana, United States
• Study site — Milford, Massachusetts, United States
• Study site — Royal Oak, Michigan, United States
• Study site — Elizabeth, New Jersey, United States
• Study site — Holmdel, New Jersey, United States
• Study site — Camillus, New York, United States
• Study site — Beaver, Pennsylvania, United States
• Study site — Feasterville, Pennsylvania, United States
• Study site — Hatboro, Pennsylvania, United States
• Study site — Summerville, South Carolina, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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