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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00481689
First received: June 1, 2007
Last updated: June 25, 2009
Last verified: June 2009
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical response [ Time Frame: TOC visit ] [ Designated as safety issue: Yes ]
  • Clinical response post- treatment [ Time Frame: 28-42 days after therapy ] [ Designated as safety issue: Yes ]
  • Adverse Event collection [ Time Frame: Until end of study ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: May 2004
Study Completion Date: September 2005
Intervention Details:
    Drug: Cipro XR (Ciprofloxacin, BAYQ3939)
    Active Ciprofloxacin XR ( 1000mg) given for 7 to 14 days
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481689

  Show 35 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00481689     History of Changes
Other Study ID Numbers: 11490
Study First Received: June 1, 2007
Last Updated: June 25, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Cipro
Complicated UTI
Pseudomonas aeruginosa

Additional relevant MeSH terms:
Communicable Diseases
Infection
Pseudomonas Infections
Urinary Tract Infections
Bacterial Infections
Gram-Negative Bacterial Infections
Urologic Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014