Urinary Tract Infection Clinical Trial
Official title:
A Randomized Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter Attached to an Antimicrobial Anti-Reflux Device for Reduction of Catheter-Associated Urinary Tract Infection
The primary objective of this pilot study is to demonstrate the feasibility of recruiting eligible patients for the purposes of assessing the temporal aspects and rates of Catheter Associated Urinary Tract Infection (CAUTI), based on the agreed-upon case definition so that the numbers needed for a pivotal study can be better estimated.
Status | Terminated |
Enrollment | 100 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subject is at least 18 years of age 2. Subject is expected to be catheterized with 14 or 16 French Foley catheters for at least 72 hours. 3. Subject (or a legally authorized representative) has provided written informed consent for study participation and procedures to be performed. 4. Life expectancy at least 3 months or more in the judgment of the investigator Exclusion Criteria: 1. Subjects who present with previously known, symptomatic UTI 2. Subjects with a positive urine dipstick at the time of enrollment 3. Subjects who are on systemic antibiotics within 48 hours prior to enrollment 4. Subjects with a known of suspected allergy to silicone, silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis. 5. Subjects who have had an indwelling catheter removed less than 48 hours before study enrollment. 6. Current genitourinary tract surgery or known infection 7. Subject requires use of a non-study urinary catheter 8. Subjects known to be pregnant or breast feeding at the time of enrollment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Fairview medical center | Minneapolis, | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Innovative Chemical and Environmental Technologies, Inc | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Organism Relation to CAUTI and TIC | Organisms found in relation to CAUTI events in TIC versus control. | up to 30th day from the time of catheterization | No |
Primary | Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event. | All randomized subjects will be followed until (1) up to 30th day from the time of catheterization or (2) the subject withdraws or is discharged from the hospital, whichever comes first and (3) 48 hours after the catheter is removed. Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for = 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP. |
up to 30th day from the time of catheterization | No |
Primary | The Proportion of Subjects With at Least One CAUTI | CAUTI is as determined by blinded investigator assessment per protocol definition. DAYS TO CAUTI = (DATE OF EVENT - DATE OF CZD INSERTION) + 1. Date of event for subjects who had CAUTI is the date of urine sample collection where the CAUTI criteria are met. Date of event for subjects who did not have CAUTI is the last available urine culture collection date from samples collected during & post CZD. p-values of time of CAUTI were obtained from log-rank test. p-values of Incidence of CAUTI were obtained from the Logistic Regression Model. Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for = 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP. CZD = Catheterized or catheter |
48 ± 24 hours or more | No |
Secondary | The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI) | Patients with catheter related SUTI are those having an indwelling urinary catheter in place at the time of specimen collection, or had an indwelling catheter within the previous 48 hours, and at least 1 of the following signs or symptoms with no other recognized cause: fever (>38°C), suprapubic tenderness, or costovertebral angle pain or tenderness and a positive urinalysis demonstrated by at least one of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite, b. pyuria (urine specimen collected from the catheter with =10 white blood cells [WBC]/mm3 or =3 WBC/high power field of unspun urine), c. microorganisms seen on Gram stain of unspun urine and a positive urine | up to 30th day from the time of catheterization | No |
Secondary | The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI) | Patients having an indwelling urinary catheter who have no signs or symptoms (i.e., no fever (>38°C), no urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), and a positive urine culture from urine collected from the catheter sampling port (or a midstream voided clean catch urine in subjects being followed for 48 hours post catheter removal) of >105 CFU/ml with no more than 2 species of uropathogen microorganisms and a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture. | up to 30th day from the time of catheterization | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03235947 -
Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients
|
Phase 4 | |
Withdrawn |
NCT01881165 -
Cranberry on Urinary Tract Infections
|
Phase 4 | |
Terminated |
NCT02198833 -
Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection
|
N/A | |
Completed |
NCT01687114 -
Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products
|
N/A | |
Completed |
NCT02357758 -
Effects of Antibiotic Prophylaxis on Recurrent UTI in Children
|
Phase 4 | |
Completed |
NCT01391793 -
Corticosteroids for Children With Febrile Urinary Tract Infections
|
Phase 3 | |
Completed |
NCT01219595 -
Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women
|
N/A | |
Completed |
NCT00365430 -
SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes
|
N/A | |
Recruiting |
NCT04502095 -
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy
|
Phase 4 | |
Completed |
NCT00976963 -
Single Dose Monurol for Treatment of Acute Cystitis
|
N/A | |
Recruiting |
NCT02568800 -
Prolonged Infusion Cefepime and Nosocomial Infections
|
Phase 3 | |
Completed |
NCT02785445 -
Healthy.io Method Comparison & User Performance Study
|
N/A | |
Completed |
NCT02216253 -
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection.
|
N/A | |
Completed |
NCT01478620 -
Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
|
Phase 3 | |
Completed |
NCT01054690 -
Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)
|
N/A | |
Completed |
NCT00371631 -
Colonizing Neurogenic Bladders With Benign Flora
|
Phase 1 | |
Terminated |
NCT03697993 -
Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS)
|
Phase 4 | |
Terminated |
NCT01803919 -
Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients
|
N/A | |
Enrolling by invitation |
NCT01231737 -
Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)
|
Phase 2 | |
Completed |
NCT01763008 -
A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
|
Phase 4 |