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

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:

• 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

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