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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00481689
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : June 26, 2009
Sponsor:
Information provided by:
Bayer

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Drug: Cipro XR (Ciprofloxacin, BAYQ3939) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2004
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Cipro XR (Ciprofloxacin, BAYQ3939)
    Active Ciprofloxacin XR ( 1000mg) given for 7 to 14 days


Primary Outcome Measures :
  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. [ Time Frame: 28-42 days after therapy ]

Secondary Outcome Measures :
  1. Clinical response [ Time Frame: TOC visit ]
  2. Clinical response post- treatment [ Time Frame: 28-42 days after therapy ]
  3. Adverse Event collection [ Time Frame: Until end of study ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481689


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35206
Birmingham, Alabama, United States, 35209
Huntsville, Alabama, United States, 35801
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
Cudahy, California, United States, 90201
Fresno, California, United States, 93720-0153
La Mesa, California, United States, 91942-3058
Laguna Hills, California, United States, 92653
Long Beach, California, United States, 90806
Los Angeles, California, United States, 90015
San Diego, California, United States, 92103
Torrance, California, United States, 90503
United States, Connecticut
Waterbury, Connecticut, United States, 06708
United States, Florida
Ocala, Florida, United States, 34474
Pembroke Pines, Florida, United States, 33027
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Iowa
Des Moines, Iowa, United States, 50309
Iowa City, Iowa, United States, 52242-1089
United States, Massachusetts
Watertown, Massachusetts, United States, 02472
United States, Missouri
St. Louis, Missouri, United States, 63125
United States, Nevada
Las Vegas, Nevada, United States, 89109
Reno, Nevada, United States, 89511-2069
United States, New Jersey
East Orange, New Jersey, United States, 07918
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
Albuquerque, New Mexico, United States, 87109
United States, New York
Manhasset, New York, United States, 11030-1961
North Massapequa, New York, United States, 11758
Troy, New York, United States, 12180-1695
United States, Oregon
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107-5096
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Texas
San Antonio, Texas, United States, 78229
United States, Virginia
Richmond, Virginia, United States, 23249-0002
United States, Washington
Tacoma, Washington, United States, 98431-5000
United States, Wyoming
Cheyenne, Wyoming, United States, 82001
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00481689    
Other Study ID Numbers: 11490
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: June 26, 2009
Last Verified: June 2009
Keywords provided by Bayer:
Cipro
Complicated UTI
Pseudomonas aeruginosa
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Pseudomonas Infections
Urologic Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors