Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release (Cipro® XR) 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas Aeruginosa And Other Common Uropathogens
Prospective, Open-Label, Noncomparative, Multicenter Study to Evaluate the Efficacy and Safety of Ciprofloxacin Extended Release (Cipro XR) 1000 mg Tablets Given Once Daily for 7 to 14 Days in the Treatment of Patients 18 Years or Older With Complicated Urinary Tract Infections Caused by Pseudomonas Aeruginosa and Other Common Uropathogens
1 other identifier
interventional
500
1 country
35
Brief Summary
Researchers want to find out if a drug called Cipro® XR (ciprofloxacin extended-release) can help people with a complicated urinary tract infection caused by a kind of bacteria called Pseudomonas aeruginosa. The study doctor will give Cipro XR to some people to see if it is safe and works to treat complicated urinary tract infections caused by Pseudomonas aeruginosa. The study doctor will also gather information about using Cipro XR to treat complicated urinary tract infections caused by other bacteria. About 500 people with complicated urinary tract infections who are 18 years old and older will join this study. Cipro XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of complicated urinary tract infections and acute uncomplicated pyelonephritis (inflammation of the kidney). The dose of Cipro XR used in this study (1000 mg a day for 7 to 14 days), has been shown to be safe and effective. This study is being done to gather more information on using this dose of Cipro XR for complicated urinary tract infections caused by Pseudomonas aeruginosa, as well as by other bacteria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2004
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 1, 2007
CompletedFirst Posted
Study publicly available on registry
June 4, 2007
CompletedJune 26, 2009
June 1, 2009
June 1, 2007
June 25, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate safety and efficacy of ciprofloxacin XR for treatment of subjects with complicated urinary tract infections caused by P. aeruginosa and other urinary pathogens.
28-42 days after therapy
Secondary Outcomes (3)
Clinical response
TOC visit
Clinical response post- treatment
28-42 days after therapy
Adverse Event collection
Until end of study
Interventions
Active Ciprofloxacin XR ( 1000mg) given for 7 to 14 days
Eligibility Criteria
You may qualify if:
- Men or non-pregnant women, 18 years of age or older with a suspected complicated urinary tract infection with an onset of symptoms 72 hours or less prior to study entry
- Patients must present with a least one sign or symptom of a lower UTI (dysuria, urgency, frequency, suprapubic pain) or for spinal cord injury patients if such symptoms are not present, at least one of the following: fever (T \> 38º C or 100.4º F orally), onset of urinary incontinence, increased spasticity, autonomic hyperreflexia, increased sweating, or cloudy and odorous urine.
- Patients must have at least one of the underlying conditions
- Indwelling urinary catheter or intermittent catheterization
- mL of residual urine after voiding
- Neurogenic bladder
- Obstruction due to nephrolithiasis, tumor or fibrosis
- Urinary retention due to benign prostatic hypertrophy, bladder cancer or other urological anatomic abnormalities
- Patients must have pyuria prior to enrollment (within 48 hours) defined as \> 10 leukocytes/mm3 in unspun urine by hemocytometer or \> 5 leukocytes/hpf in resuspended sediment of centrifuged urine
- Patients must have one clean-catch, midstream urine culture or culture from catheter (obtained using sterile technique, not from a Foley bag) that was obtained within 48 hours of enrollment and had a positive results:
- Defined as \>= 100000 CFU/mL (\>= 10000 CFU/mL for S. saprophyticus) for a causative pathogen
- If more than 1 pathogen is identified, each should be present at a colony count \>= 100000 CFU/mL (\>= 10000 CFU/mL for S. saprophyticus) to be included in the analysis
- For catheterized patients two or more pathogens (\>= 100000 CFU/mL) (\>= 10000 CFU/mL for S. saprophyticus) isolated from a baseline urine culture will be considered contaminants unless simultaneous blood culture yields the same pathogen(s)
- The causative pathogen must be susceptible to ciprofloxacin on in vitro susceptibility testing
- Enrollment and start of treatment is permitted prior to the availability of the culture report
You may not qualify if:
- Have a history of allergy to quinolones
- Are unable to take or inability to tolerate oral medications
- History of prostatitis or epididymitis
- Have signs and symptoms of pyelonephritis \[all of the following: fever (T\>38° C/100.4° F orally), chills, and flank pain or costovertebral angle tenderness\]
- Have an intractable infection requiring \> 14 days of therapy
- Have an uncomplicated UTI
- Have a renal transplant
- Have ileal loops or vesico-ureteral reflux
- Have a ciprofloxacin-resistant pathogen upon urine or blood culture
- Have received systemic antimicrobial therapy within 48 hours prior to enrollment
- Have a neutrophil count \<1000/mm3, CD4 \< 200/mm3 or other conditions associated with significant depression in host defense; HIV testing is not mandatory
- Have a requirement for concomitant systemic antibacterial therapy with agents not specified in this protocol
- Have significant liver impairment (baseline SGOT or SGPT and/or total bilirubin greater than 3 times the upper limit of normal)
- Have significant renal impairment (serum creatinine \> 3.0 mg/dl or creatinine clearance \< 30 mL/min/1.73 m2)
- Have a history of tendinopathy associated with fluoroquinolones
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (35)
Unknown Facility
Birmingham, Alabama, 35206, United States
Unknown Facility
Birmingham, Alabama, 35209, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Scottsdale, Arizona, 85258, United States
Unknown Facility
Cudahy, California, 90201, United States
Unknown Facility
Fresno, California, 93720-0153, United States
Unknown Facility
La Mesa, California, 91942-3058, United States
Unknown Facility
Laguna Hills, California, 92653, United States
Unknown Facility
Long Beach, California, 90806, United States
Unknown Facility
Los Angeles, California, 90015, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Torrance, California, 90503, United States
Unknown Facility
Waterbury, Connecticut, 06708, United States
Unknown Facility
Ocala, Florida, 34474, United States
Unknown Facility
Pembroke Pines, Florida, 33027, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Des Moines, Iowa, 50309, United States
Unknown Facility
Iowa City, Iowa, 52242-1089, United States
Unknown Facility
Watertown, Massachusetts, 02472, United States
Unknown Facility
St Louis, Missouri, 63125, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Reno, Nevada, 89511-2069, United States
Unknown Facility
East Orange, New Jersey, 07918, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Unknown Facility
Albuquerque, New Mexico, 87109, United States
Unknown Facility
Manhasset, New York, 11030-1961, United States
Unknown Facility
North Massapequa, New York, 11758, United States
Unknown Facility
Troy, New York, 12180-1695, United States
Unknown Facility
Eugene, Oregon, 97401, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107-5096, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Richmond, Virginia, 23249-0002, United States
Unknown Facility
Tacoma, Washington, 98431-5000, United States
Unknown Facility
Cheyenne, Wyoming, 82001, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 1, 2007
First Posted
June 4, 2007
Study Start
May 1, 2004
Study Completion
September 1, 2005
Last Updated
June 26, 2009
Record last verified: 2009-06