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Terminated for futility reasons.
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Urinary catheters are often needed in hospital patients, but their use can increase the chance that a catheter associated urinary tract infection (called a CAUTI) may occur. This study will try to determine if patients who get a new silver coated catheter will have slower to time to development of a CAUTI compared to patients who get an uncoated catheter.
This study is a prospective, multicenter, randomized controlled pivotal study designed to compare the time to occurrence and incidence of CAUTI in subjects catheterized with a new hydrogel-silver salts latex catheter (test) to those of subjects catheterized with a silicone elastomer-coated latex catheter (control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver-coated catheter | Experimental | Bard Hydrogel Silver Salts Coated Latex Urinary Catheter System |
|
| Silicone-coated catheter | Placebo Comparator | Bard silicone elastomer coated latex catheter system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogel Silver Salts Coated Latex Urinary Catheter System | Device | Silver-coated catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours | Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations. | >=48 hours to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a bUTI After Catheterization for >= 48 Hours | The percentage of bUTI was calculated as the rate of new occurrence of bUTI in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion. | >=48 hours to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a bUTI Catheterized for >=48 Hours. | bUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion. | From time of catheterization until 10 days post catheterization or 48 hours after catheter removal. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Rupp, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
Subjects judged by site personnel to require a urinary catheter for at least 48-72 hours were screened against the study inclusion/exclusion criteria. Those subjects meeting these criteria were offered participation in the study.
Twenty Investigators at 20 Investigative Sites enrolled a total of 1188 study subjects between June 28, 2007 and June 23, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Silver-coated Catheter | Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter |
| FG001 | Silicone-coated Catheter | silicone elastomer-coated latex catheter |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Silver-coated Catheter | Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter |
| BG001 | Silicone-coated Catheter | silicone elastomer-coated latex catheter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants With a bUTI After Catheterization for >= 48 Hours | The percentage of bUTI was calculated as the rate of new occurrence of bUTI in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion. | Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion. | Posted | Number | Percentage of Participants with a bUTI | >=48 hours to 10 days |
|
Adverse events were collected from the time of attempted or successful catheter insertion throughout the period of catheterization with the study catheter and for a period of 48 hours following study catheter removal, or until hospital discharge.
AE Definition: any undesirable clinical occurrence in a subject that is related to either the urinary tract, or systemic infection.
All SAEs were collected, as defined in 21 CFR 803.3.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silver-coated Catheter | Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematuria | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
Sample size calculations required 1244 Efficacy Evaluable 48 subjects, only 854 Efficacy Evaluable 48 subjects were enrolled, which does not allow for a fully powered study and there is the threat of a type II error (false negative result).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanessa Dell Clinical Research Scientist | C. R. Bard | 908-277-8094 | vanessa.dell@crbard.com |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Bard silicone elastomer coated latex catheter system | Device | Silicone-coated catheter |
|
|
| Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours | The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations. | >= 48 hours to 10 days |
| Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours | Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 24 hours and developed a bUTI at after catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations. | >= 24 hours to 10 days |
| Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours | The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations. | >= 24 hours to 10 days |
| Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL | The number of subjects with bacteriuria levels ≥ 10e3 < 10e5 CFU/mL who subsequently developed a bUTI or a sUTI | 10 days |
| Number of Subjects With a sUTI Catheterized for >=48 Hours. | sUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion. | From time of catheterization until 10 days or 48 hours after catheter was removed |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
silicone elastomer-coated latex catheter |
|
|
| Primary | Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours | Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations. | Efficacy Evaluable (48) population: Intent-to-treat (ITT) subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a bUTI after catheter insertion. | Posted | Median | Standard Deviation | Days | >=48 hours to 10 days |
|
|
|
| Secondary | Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours | The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations. | Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a sUTI after catheter insertion. | Posted | Median | Standard Deviation | Days | >= 48 hours to 10 days |
|
|
|
| Secondary | Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours | Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for >= 24 hours and developed a bUTI at after catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations. | Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion. | Posted | Median | Standard Deviation | Days | >= 24 hours to 10 days |
|
|
|
| Secondary | Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours | The time to occurrence of sUTI was measured as the time between catheter insertion and when the criteria for sUTI was met, up to 10 days after catheterization plus 48 hours after catheter removal. Subjects who did not have a sUTI are not included in the median calculation, so the median only includes data from non-censored observations. | Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion. | Posted | Median | Standard Deviation | Days | >= 24 hours to 10 days |
|
|
|
| Secondary | Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL | The number of subjects with bacteriuria levels ≥ 10e3 < 10e5 CFU/mL who subsequently developed a bUTI or a sUTI | Safety population: ITT subjects who were catheterized with a study catheter. This population was used to assess tolerability and safety endpoints. | Posted | Number | Participants | 10 days |
|
|
|
| Other Pre-specified | Number of Subjects With a bUTI Catheterized for >=48 Hours. | bUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion. | Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion. | Posted | Number | Participants | From time of catheterization until 10 days post catheterization or 48 hours after catheter removal. |
|
|
|
| Other Pre-specified | Number of Subjects With a sUTI Catheterized for >=48 Hours. | sUTI occurences were counted in subjects of both study groups who had been catheterized with a study catheter for >= 48 hours and who did not have evidence of bUTI at the time of study catheter insertion. | Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who did not have a bUTI in the baseline urine sample obtained at the time of catheter insertion. | Posted | Number | Participants | From time of catheterization until 10 days or 48 hours after catheter was removed |
|
|
|
| 47 |
| 565 |
| 15 |
| 565 |
| EG001 | Silicone-coated Catheter | silicone elastomer-coated latex catheter | 58 | 568 | 29 | 568 |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Increased Bronchial Secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Obstructive Airways Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cardiac Tamponade | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Right Ventricular Failure | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ventricular Fibrillation | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Postoperative Ileus | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Anastomotic Leak | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Reocclusion | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Enterocutaneous Fistula | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Retroperitoneal Haematoma | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Acute Prerenal Failure | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Renal Tubular Necrosis | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cerebellar Haemorrhage | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Syncope Vasovagal | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Alcohol Withdrawal Syndrome | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Multi-Organ Failure | General disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Blood Amylase Increased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Blood Creatine Increased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Lipase Increased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Lactic Acidosis | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Mobility Decreased | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Acute Myeloid Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Wound Drainage | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |