check_circleStudy Completed

Urinary Tract Infections

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

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years

  • - 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 voidingo 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:
     -- 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 testing5. Enrollment and start of treatment is permitted prior to the availability of the culture report
  • - 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 protoco
    l- 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 summary

Enrollment Goal
500
Trial Dates
May 2004 - September 2005
Phase
Phase 4
Could I Receive a placebo
No
Products
Cipro XR (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Center for Urological ResearchLa Mesa, 91942-3058, United States
Completed
Urological Physicians of San DiegoSan Diego, 92103, United States
Completed
ACT - Albuquerque Clinical TrialsAlbuquerque, 87102, United States
Completed
Florida Foundation for Healthcare ResearchOcala, 34474, United States
Completed
Madigan Army Medical CenterTacoma, 98431-5000, United States
Completed
Urology Group of New MexicoAlbuquerque, 87109, United States
Completed
Alabama Research Center, LLCBirmingham, 35209, United States
Completed
Scottsdale Urologic & Reproductive SpecialistsScottsdale, 85258, United States
Completed
South Florida Urology CenterPembroke Pines, 33027, United States
Completed
Clinical Research SolutionsLas Vegas, 89109, United States
Completed
Rx for Life, Inc.Cudahy, 90201, United States
Completed
Iowa Clinic,PC/ Iowa UrololgyDes Moines, 50309, United States
Completed
Urology Specialists, PCWaterbury, 06708, United States
Completed
DiGiovanna Family Care CenterNorth Massapequa, 11758, United States
Completed
VA New Jersey Health Care SystemEast Orange, 07918, United States
Completed
Atlantic Urology Medical GroupLong Beach, 90806, United States
Completed
South Coast Urological Medical GroupLaguna Hills, 92653, United States
Completed
Urology San Antonio Research, PASan Antonio, 78229, United States
Completed
Urology of Indiana, LLCIndianapolis, 46202, United States
Completed
Nevada Urology AssociatesReno, 89511-2069, United States
Completed
Medical Affiliated Research Center, Inc.Huntsville, 35801, United States
Completed
Urology Associates of Central CaliforniaFresno, 93720-0153, United States
Completed
Parkway Medical CenterBirmingham, 35206, United States
Completed
Wyoming Research Foundation, Inc.Cheyenne, 82001, United States
Completed
Seton Health SystemTroy, 12180-1695, United States
Completed
VA Medical Center-Jefferson Barracks DivisionSt. Louis, 63125, United States
Completed
Southeast Urology NetworkMemphis, 38119, United States
Completed
McGuire Veterans Affairs Medical CenterRichmond, 23249-0002, United States
Completed
Health Care Partners Medical GroupTorrance, 90503, United States
Completed
Bay State Clinical Trials, IncWatertown, 02472, United States
Completed
Thomas Jefferson University HospitalsPhiladelphia, 19107-5096, United States
Completed
Healthcare Partners Medical GroupLos Angeles, 90015, United States
Completed
Oregon Urology SpecialistsEugene, 97401, United States
Completed
University of Iowa Hospitals & ClinicsIowa City, 52242-1089, United States
Completed
Urology Associates, PCManhasset, 11030-1961, United States

Primary Outcome

  • 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.
    date_rangeTime Frame:
    28-42 days after therapy
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Clinical response
    date_rangeTime Frame:
    TOC visit
    enhanced_encryption
    Safety Issue:
    yes
  • Clinical response post- treatment
    date_rangeTime Frame:
    28-42 days after therapy
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    Safety Issue:
    yes
  • Adverse Event collection
    date_rangeTime Frame:
    Until end of study
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    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
N/A