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

June 25, 2009 updated by: Bayer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
      • Birmingham, Alabama, United States, 35206
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Scottsdale, Arizona, United States, 85258
    • 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
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
    • Florida
      • Ocala, Florida, United States, 34474
      • Pembroke Pines, Florida, United States, 33027
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Iowa
      • Des Moines, Iowa, United States, 50309
      • Iowa City, Iowa, United States, 52242-1089
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
    • Missouri
      • St. Louis, Missouri, United States, 63125
    • Nevada
      • Las Vegas, Nevada, United States, 89109
      • Reno, Nevada, United States, 89511-2069
    • New Jersey
      • East Orange, New Jersey, United States, 07918
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
      • Albuquerque, New Mexico, United States, 87109
    • New York
      • Manhasset, New York, United States, 11030-1961
      • North Massapequa, New York, United States, 11758
      • Troy, New York, United States, 12180-1695
    • Oregon
      • Eugene, Oregon, United States, 97401
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5096
    • Tennessee
      • Memphis, Tennessee, United States, 38119
    • Texas
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Richmond, Virginia, United States, 23249-0002
    • Washington
      • Tacoma, Washington, United States, 98431-5000
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
28-42 days after therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Clinical response
Time Frame: TOC visit
TOC visit
Clinical response post- treatment
Time Frame: 28-42 days after therapy
28-42 days after therapy
Adverse Event collection
Time Frame: Until end of study
Until end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11490

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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