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

Urinary Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669994
• Other study ID #: 100546
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2008
• Last updated: December 18, 2014
• Start date: July 2003
• Est. completion date: October 2003

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Ciprofloxacin
Cipro XR 500 mg tablets taken once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteriologic outcome in patients with UTI caused by S. saprophyticus		4-11 days post-treatment	No
Secondary	Adverse Events Collection		Up to 4-11 days post-treatment	Yes
Secondary	Clinical Response		4-11 days post-treatment	Yes
Secondary	Incidence of premature terminations		Premature discontinuation	Yes

External Links

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