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Urinary Tract InfectionsPhase 4NCT00481689

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

A Phase 4 study testing Cipro XR (Ciprofloxacin, BAYQ3939) in people with Urinary Tract Infections, run by Bayer at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Tract Infections
What is being tested?
Cipro XR (Ciprofloxacin, BAYQ3939)
How many people
500 participants
Where
35 sitesUnited States
Study dates
May 2004to Sep 2005
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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 testing
  • Enrollment and start of treatment is permitted prior to the availability of the culture report

Who cannot join

  • 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
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  • 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

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Albuquerque, New Mexico, 87109

  • Study site

    Birmingham, Alabama, 35206

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Cheyenne, Wyoming, 82001

  • Study site

    Cudahy, California, 90201

  • Study site

    Des Moines, Iowa, 50309

  • Study site

    East Orange, New Jersey, 07918

  • Study site

    Eugene, Oregon, 97401

  • Study site

    Fresno, California, 93720-0153

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Iowa City, Iowa, 52242-1089

  • Study site

    La Mesa, California, 91942-3058

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Las Vegas, Nevada, 89109

  • Study site

    Long Beach, California, 90806

  • Study site

    Los Angeles, California, 90015

  • Study site

    Manhasset, New York, 11030-1961

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    North Massapequa, New York, 11758

  • Study site

    Ocala, Florida, 34474

  • Study site

    Pembroke Pines, Florida, 33027

  • Study site

    Philadelphia, Pennsylvania, 19107-5096

  • Study site

    Reno, Nevada, 89511-2069

  • Study site

    Richmond, Virginia, 23249-0002

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92103

  • Study site

    Scottsdale, Arizona, 85258

  • Study site

    St Louis, Missouri, 63125

  • Study site

    Tacoma, Washington, 98431-5000

  • Study site

    Torrance, California, 90503

  • Study site

    Troy, New York, 12180-1695

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    Watertown, Massachusetts, 02472

Other trials in United States

About this study

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

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.

Being tested
Cipro XR (Ciprofloxacin, BAYQ3939)
Keywords
Cipro, Complicated UTI, Pseudomonas aeruginosa
Medical subject headings
Urinary Tract Infections, Pseudomonas Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cipro XR (Ciprofloxacin, BAYQ3939)Drug

    Active Ciprofloxacin XR ( 1000mg) given for 7 to 14 days

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 28-42 days after therapy

Secondary outcomes (3)

  1. Clinical response

    Measured: TOC visit

  2. Clinical response post- treatment

    Measured: 28-42 days after therapy

  3. Adverse Event collection

    Measured: Until end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2007 (estimated)
  2. Study startMay 2004
  3. Study completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00481689
Sponsor's protocol ID
11490
Status last verified
Jun 2009
First submitted
1 Jun 2007
Last updated
26 Jun 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cipro XR (Ciprofloxacin, BAYQ3939) in people with Urinary Tract Infections, run by Bayer at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00481689.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2009.

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