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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00669994

Collaborator

(none)

180

Enrollment

Locations

Arm

Duration (Months)

5.8

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection	Drug: Ciprofloxacin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

180 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2003

Actual Study Completion Date :

Oct 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Ciprofloxacin Cipro XR 500 mg tablets taken once daily

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Ciprofloxacin

Cipro XR 500 mg tablets taken once daily

Outcome Measures

Primary Outcome Measures

Bacteriologic outcome in patients with UTI caused by S. saprophyticus [4-11 days post-treatment]

Secondary Outcome Measures

Adverse Events Collection [Up to 4-11 days post-treatment]
Clinical Response [4-11 days post-treatment]
Incidence of premature terminations [Premature discontinuation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Birmingham	Alabama	United States	35205
2	Birmingham	Alabama	United States	35242
3	Pelham	Alabama	United States	35124
4	Phoenix	Arizona	United States	85023
5	Laguna Hills	California	United States	92653
6	Long Beach	California	United States	90806
7	San Diego	California	United States	92182-4701
8	San Luis Obispo	California	United States	93401
9	San Mateo	California	United States	94403-4398
10	Sylmar	California	United States	91342
11	Yorba Linda	California	United States	92886
12	Avon	Connecticut	United States	06001
13	Clearwater	Florida	United States	33761
14	Pembroke Pines	Florida	United States	33024
15	Evansville	Indiana	United States	47714
16	Milford	Massachusetts	United States	01757
17	Royal Oak	Michigan	United States	48073-6769
18	Elizabeth	New Jersey	United States	07202-3672
19	Holmdel	New Jersey	United States	07733
20	Camillus	New York	United States	13031
21	Beaver	Pennsylvania	United States	15009
22	Feasterville	Pennsylvania	United States	19053
23	Hatboro	Pennsylvania	United States	19040
24	Summerville	South Carolina	United States	29485
25	San Antonio	Texas	United States	78209
26	Murray	Utah	United States	84107
27	Salt Lake City	Utah	United States	84102
28	Salt Lake City	Utah	United States	84109
29	Salt Lake City	Utah	United States	84121
30	West Jordan	Utah	United States	84088
31	Madison	Wisconsin	United States	53715