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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00481689

Collaborator

(none)

500

Enrollment

Locations

Duration (Months)

14.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections	Drug: Cipro XR (Ciprofloxacin, BAYQ3939)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2004

Actual Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

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. [28-42 days after therapy]

Secondary Outcome Measures

Clinical response [TOC visit]
Clinical response post- treatment [28-42 days after therapy]
Adverse Event collection [Until end of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Birmingham	Alabama	United States	35206
2	Birmingham	Alabama	United States	35209
3	Huntsville	Alabama	United States	35801
4	Scottsdale	Arizona	United States	85258
5	Cudahy	California	United States	90201
6	Fresno	California	United States	93720-0153
7	La Mesa	California	United States	91942-3058
8	Laguna Hills	California	United States	92653
9	Long Beach	California	United States	90806
10	Los Angeles	California	United States	90015
11	San Diego	California	United States	92103
12	Torrance	California	United States	90503
13	Waterbury	Connecticut	United States	06708
14	Ocala	Florida	United States	34474
15	Pembroke Pines	Florida	United States	33027
16	Indianapolis	Indiana	United States	46202
17	Des Moines	Iowa	United States	50309
18	Iowa City	Iowa	United States	52242-1089
19	Watertown	Massachusetts	United States	02472
20	St. Louis	Missouri	United States	63125
21	Las Vegas	Nevada	United States	89109
22	Reno	Nevada	United States	89511-2069
23	East Orange	New Jersey	United States	07918
24	Albuquerque	New Mexico	United States	87102
25	Albuquerque	New Mexico	United States	87109
26	Manhasset	New York	United States	11030-1961
27	North Massapequa	New York	United States	11758
28	Troy	New York	United States	12180-1695
29	Eugene	Oregon	United States	97401
30	Philadelphia	Pennsylvania	United States	19107-5096
31	Memphis	Tennessee	United States	38119
32	San Antonio	Texas	United States	78229
33	Richmond	Virginia	United States	23249-0002
34	Tacoma	Washington	United States	98431-5000
35	Cheyenne	Wyoming	United States	82001