Trial Condition(s):

Urinary Tract Infections

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

Bayer Identifier:

11490

ClinicalTrials.gov Identifier:

NCT00481689

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
-  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 
 -- 100 mL of residual urine after voidingo 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 testing5. Enrollment and start of treatment is permitted prior to the availability of the culture report
Exclusion Criteria
- 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 protoco
 l- 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
 - Are pregnant, nursing or in whom pregnancy cannot be excluded or unreliable contraception is being used
 - Have been diagnosed with a rapidly fatal underlying disease (death expected within 6 months)
 - Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium - Have been previously enrolled in this clinical study
 - Have been taking an investigational drug in the last 30 days
 - Have a history of a UTI or bacteruria with a urinary pathogen resistant to a fluoroquinolone within 6 months prior to current UTI episode
 - Any of the following signs of sepsis:
 -- Systolic blood pressure < 90mm or a decrease of > 40mm from baseline- Hypothermia (T< 35.6°C, core)- Unexplained metabolic acidosis (pH < 7.3 with BE >= 5mmol/L or elevated lactate level)
 --  PaO2 < 75 mm/Hg on room air  or  PaO2 /FIO2 ratio < 250- Acute renal failure (urine output < 0.5mL/kg/h for >= 1h)- DIC ( PTT, PT, or platelets < 1/2 baseline or < 100,000)
 -- Acute deterioration in mental state- Hemodynamic state (CI > 4L/min/m2 + SVR < 800 dyn-sec/cm-5)15

Trial Summary

Enrollment Goal
500
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Cipro XR (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Center for Urological Research

La Mesa, United States, 91942-3058

Status
Completed
 
Locations

Urological Physicians of San Diego

San Diego, United States, 92103

Status
Completed
 
Locations

ACT - Albuquerque Clinical Trials

Albuquerque, United States, 87102

Status
Completed
 
Locations

Florida Foundation for Healthcare Research

Ocala, United States, 34474

Status
Completed
 
Locations

Madigan Army Medical Center

Tacoma, United States, 98431-5000

Status
Completed
 
Locations

Urology Group of New Mexico

Albuquerque, United States, 87109

Status
Completed
 
Locations

Alabama Research Center, LLC

Birmingham, United States, 35209

Status
Completed
 
Locations

Scottsdale Urologic & Reproductive Specialists

Scottsdale, United States, 85258

Status
Completed
 
Locations

South Florida Urology Center

Pembroke Pines, United States, 33027

Status
Completed
 
Locations

Clinical Research Solutions

Las Vegas, United States, 89109

Status
Completed
 
Locations

Rx for Life, Inc.

Cudahy, United States, 90201

Status
Completed
 
Locations

Iowa Clinic,PC/ Iowa Urololgy

Des Moines, United States, 50309

Status
Completed
 
Locations

Urology Specialists, PC

Waterbury, United States, 06708

Status
Completed
 
Locations

DiGiovanna Family Care Center

North Massapequa, United States, 11758

Status
Completed
 
Locations

VA New Jersey Health Care System

East Orange, United States, 07918

Status
Completed
 
Locations

Atlantic Urology Medical Group

Long Beach, United States, 90806

Status
Completed
 
Locations

South Coast Urological Medical Group

Laguna Hills, United States, 92653

Status
Completed
 
Locations

Urology San Antonio Research, PA

San Antonio, United States, 78229

Status
Completed
 
Locations

Urology of Indiana, LLC

Indianapolis, United States, 46202

Status
Completed
 
Locations

Nevada Urology Associates

Reno, United States, 89511-2069

Status
Completed
 
Locations

Medical Affiliated Research Center, Inc.

Huntsville, United States, 35801

Status
Completed
 
Locations

Urology Associates of Central California

Fresno, United States, 93720-0153

Status
Completed
 
Locations

Parkway Medical Center

Birmingham, United States, 35206

Status
Completed
 
Locations

Wyoming Research Foundation, Inc.

Cheyenne, United States, 82001

Status
Completed
 
Locations

Seton Health System

Troy, United States, 12180-1695

Status
Completed
 
Locations

VA Medical Center-Jefferson Barracks Division

St. Louis, United States, 63125

Status
Completed
 
Locations

Southeast Urology Network

Memphis, United States, 38119

Status
Completed
 
Locations

McGuire Veterans Affairs Medical Center

Richmond, United States, 23249-0002

Status
Completed
 
Locations

Health Care Partners Medical Group

Torrance, United States, 90503

Status
Completed
 
Locations

Bay State Clinical Trials, Inc

Watertown, United States, 02472

Status
Completed
 
Locations

Thomas Jefferson University Hospitals

Philadelphia, United States, 19107-5096

Status
Completed
 
Locations

Healthcare Partners Medical Group

Los Angeles, United States, 90015

Status
Completed
 
Locations

Oregon Urology Specialists

Eugene, United States, 97401

Status
Completed
 
Locations

University of Iowa Hospitals & Clinics

Iowa City, United States, 52242-1089

Status
Completed
 
Locations

Urology Associates, PC

Manhasset, United States, 11030-1961

Status
Completed
 

Trial Design