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

Condition(s) targeted: Urinary Tract Infections

Intervention: Cipro XR (Ciprofloxacin, BAYQ3939) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

To evaluate the safety and efficacy of ciprofloxacin XR for the treatment of subjects with complicated urinary tract infections (UTI) caused by P. aeruginosa and other urinary pathogens

To enroll a minimum of 8 patients with complicated UTI caused by P. aeruginosa that are clinically and microbiologically valid.

Secondary outcome:

The secondary efficacy endpoint will be clinical response at the TOC visit.

In addition, a secondary clinical efficacy parameter will be clinical response at the late post-treatment visit 28 to 42 days after completing therapy for subjects with P. aeruginosa infections.

Safety will be assessed based on physical examination findings, monitoring for adverse events, and clinical laboratory testing.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

- Women of childbearing potential using reliable birth control

- 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 last one of the underlying conditions

- Indwelling urinary catheter or intermittent catheterization

- 100 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:

1. Defined as >= 100000 CFU/mL (>= 10000 CFU/mL for S. saprophyticus) for a causative pathogen

2. 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

3. 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)

4. The causative pathogen must be susceptible to ciprofloxacin on in vitro susceptibility testing

5. 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 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

- 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

Alabama Research Center, LLC, Birmingham, Alabama 35209, United States

Medical Affiliated Research Center, Inc., Huntsville, Alabama 35801, United States

Parkway Medical Center, Birmingham, Alabama 35206, United States

Parkway Medical Center, Birmingham, Alabama 35206, United States

Scottsdale Urologic & Reproductive Specialists, Scottsdale, Arizona 85258, United States

Center for Urological Research, La Mesa, California 91942-3058, United States

Pacific Clinical Research, Santa Monica, California 90404, United States

Urological Physicians of San Diego, San Diego, California 92103, United States

Atlantic Urology Medical Group, Long Beach, California 90806, United States

South Coast Urological Medical Group, Laguna Hills, California 92653, United States

Rx for Life, Inc., Cudahy, California 90201, United States

Health Care Partners Medical Group, Torrance, California 90503, United States

Urology Associates of Central California, Fresno, California 93720-0153, United States

Healthcare Partners Medical Group, Los Angeles, California 90015, United States

Urology Specialists, PC, Waterbury, Connecticut 06708, United States

Florida Foundation for Healthcare Research, Ocala, Florida 34474, United States

South Florida Urology Center, Pembroke Pines, Florida 33027, United States

Urology of Indiana, LLC, Indianapolis, Indiana 46254, United States

Iowa Clinic,PC/ Iowa Urololgy, Des Moines, Iowa 50309, United States

University of Iowa Hospitals & Clinics, Iowa City, Iowa 52242-1089, United States

Bay State Clinical Trials, Inc, Watertown, Massachusetts 02472, United States

VA Medical Center, St. Louis, Missouri 63125, United States

Clinical Research Solutions, Las Vegas, Nevada 89109, United States

Nevada Urology Associates, Reno, Nevada 89511-2069, United States

VA New Jersey Health Care System, East Orange, New Jersey 07918, United States

ACT - Albuquerque Clinical Trials, Albuquerque, New Mexico 87102, United States

Urology Group of New Mexico, Albuquerque, New Mexico 87109, United States

DiGiovanna Family Care Center, North Massapequa, New York 11758, United States

Seton Health System, Troy, New York 12180-1695, United States

Urology Associates, PC, Manhasset, New York 11030-1961, United States

Oregon Urology Specialists, Eugene, Oregon 97401, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107-5096, United States

Southeast Urology Network, Memphis, Tennessee 38119, United States

Urology San Antonio Research, PA, San Antonio, Texas 78229, United States

McGuire Veterans Affairs Medical Center, Richmond, Virginia 23249-0002, United States

Madigan Army Medical Center, Tacoma, Washington 98431-5000, United States

Wyoming Research Foundation, Inc., Cheyenne, Wyoming 82001, United States

Starting date: May 2004
Last updated: June 1, 2007