Clinical trial NCT00481689: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infections
Keywords: Cipro
Complicated UTI
Pseudomonas aeruginosa
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-06-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
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.
timeFrame: 28-42 days after therapy
Secondary outcomes:
measure: Clinical response
timeFrame: TOC visit
measure: Clinical response post- treatment
timeFrame: 28-42 days after therapy
measure: Adverse Event collection
timeFrame: Until end of study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Cudahy
country: United States
state: California
city: Fresno
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Waterbury
country: United States
state: Connecticut
city: Ocala
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Watertown
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Reno
country: United States
state: Nevada
city: East Orange
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albuquerque
country: United States
state: New Mexico
city: Manhasset
country: United States
state: New York
city: North Massapequa
country: United States
state: New York
city: Troy
country: United States
state: New York
city: Eugene
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: Cheyenne
country: United States
state: Wyoming
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: