Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS)

• Sponsor: C. R. Bard (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00482547
• Collaborator: (none)
• Enrollment: 1,188
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 84.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Catheterization	Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System; Device: Bard silicone elastomer coated latex catheter system	Phase 4

Detailed Description

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 1188 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Study of a Urethral Catheter Coated With Eluting Silver Salts
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Silver-coated catheter Bard Hydrogel Silver Salts Coated Latex Urinary Catheter System	Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System; Silver-coated catheter; Other Names: AgSC arm
Placebo Comparator: Silicone-coated catheter Bard silicone elastomer coated latex catheter system	Device: Bard silicone elastomer coated latex catheter system; Silicone-coated catheter; Other Names: SiCS arm

Outcome Measures

Primary Outcome Measures

1. Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours [>=48 hours to 10 days]

   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.

Secondary Outcome Measures

1. Percentage of Participants With a bUTI After Catheterization for >= 48 Hours [>=48 hours to 10 days]

   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.

2. Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours [>= 48 hours to 10 days]

   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.

3. Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours [>= 24 hours to 10 days]

   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.

4. Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours [>= 24 hours to 10 days]

   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.

5. Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL [10 days]

   The number of subjects with bacteriuria levels ≥ 10e3 < 10e5 CFU/mL who subsequently developed a bUTI or a sUTI

Other Outcome Measures

1. Number of Subjects With a bUTI Catheterized for >=48 Hours. [From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.]

   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.

2. Number of Subjects With a sUTI Catheterized for >=48 Hours. [From time of catheterization until 10 days or 48 hours after catheter was removed]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• male or female at least 18 years of age

• life expectancy of 3 months or more

• expected to require a urinary catheter for at least 48 hours

Exclusion Criteria:

• recent urinary tract surgery or instrumentation

• presence of a urinary tract device

• concurrent genitourinary tract infection

• recent indwelling urinary catheter

• requires use of a non-study urinary catheter

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Hospital	Detroit	Michigan	United States	48202

Sponsors and Collaborators

• C. R. Bard

Investigators

• Principal Investigator: Mark Rupp, MD, University of Nebraska

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT00482547
• Other Study ID Numbers: BMD-6003
• First Posted: Jun 5, 2007
• Last Update Posted: Feb 28, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by C. R. Bard: urinary tract infection; urinary catheter

Study Results

Participant Flow

Recruitment Details	Twenty Investigators at 20 Investigative Sites enrolled a total of 1188 study subjects between June 28, 2007 and June 23, 2008.
Pre-assignment Detail	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.

Arm/Group Title	Silver-coated Catheter	Silicone-coated Catheter
Arm/Group Description	Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter	silicone elastomer-coated latex catheter
Period Title: Overall Study
STARTED	599	589
Successful Catheterization	565	568
48 Hour Evaluation	426	428
COMPLETED	426	428
NOT COMPLETED	173	161

Baseline Characteristics

Arm/Group Title	Silver-coated Catheter	Silicone-coated Catheter	Total
Arm/Group Description	Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter	silicone elastomer-coated latex catheter	Total of all reporting groups
Overall Participants	599	589	1188
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	302 50.4%	287 48.7%	589 49.6%
>=65 years	297 49.6%	302 51.3%	599 50.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.7 (15.9)	64.3 (14.5)	64.0 (15.2)
Gender (Count of Participants)
Female	341 56.9%	332 56.4%	673 56.6%
Male	258 43.1%	257 43.6%	515 43.4%
Region of Enrollment (participants) [Number]
United States	599 100%	589 100%	1188.0 100%

Outcome Measures

1. Secondary Outcome

Title	Percentage of Participants With a bUTI After Catheterization for >= 48 Hours
Description	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.
Time Frame	>=48 hours to 10 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Silver-coated Catheter	Silicone-coated Catheter
Arm/Group Description	Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter	silicone elastomer-coated latex catheter
Measure Participants	426	428
Number [Percentage of Participants with a bUTI]	13.4 2.2%	17.8 3%

2. Primary Outcome

Title	Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours
Description	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.
Time Frame	>=48 hours to 10 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Silver-coated Catheter	Silicone-coated Catheter
Arm/Group Description	Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter	silicone elastomer-coated latex catheter
Measure Participants	57	76
Median (Standard Deviation) [Days]	2.10 (1.99)	2.06 (2.32)

3. Secondary Outcome

Title	Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours
Description	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.
Time Frame	>= 48 hours to 10 days

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable (48) population: ITT subjects who were catheterized with a study catheter for ≥ 48 hours and who developed a sUTI after catheter insertion.

Arm/Group Title	Silver-coated Catheter	Silicone-coated Catheter
Arm/Group Description	Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter	silicone elastomer-coated latex catheter
Measure Participants	37	38
Median (Standard Deviation) [Days]	1.23 (1.75)	1.62 (1.48)

4. Secondary Outcome

Title	Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours
Description	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.
Time Frame	>= 24 hours to 10 days

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.

Arm/Group Title	Silver-coated Catheter	Silicone-coated Catheter
Arm/Group Description	Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter	silicone elastomer-coated latex catheter
Measure Participants	61	78
Median (Standard Deviation) [Days]	2.03 (1.98)	2.04 (2.31)

5. Secondary Outcome

Title	Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours
Description	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.
Time Frame	>= 24 hours to 10 days

Outcome Measure Data

Analysis Population Description

Efficacy Evaluable (24) population: ITT subjects who were catheterized with a study catheter for ≥ 24 hours and who developed a bUTI after catheter insertion.

Arm/Group Title	Silver-coated Catheter	Silicone-coated Catheter
Arm/Group Description	Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter	silicone elastomer-coated latex catheter
Measure Participants	39	39
Median (Standard Deviation) [Days]	1.1039 (1.73)	1.40 (1.47)

6. Secondary Outcome

Title	Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL
Description	The number of subjects with bacteriuria levels ≥ 10e3 < 10e5 CFU/mL who subsequently developed a bUTI or a sUTI
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Safety population: ITT subjects who were catheterized with a study catheter. This population was used to assess tolerability and safety endpoints.

Arm/Group Title	Silver-coated Catheter	Silicone-coated Catheter
Arm/Group Description	Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter	silicone elastomer-coated latex catheter
Measure Participants	565	568
Number [Participants]	38 6.3%	35 5.9%

7. Other Pre-specified Outcome

Title	Number of Subjects With a bUTI Catheterized for >=48 Hours.
Description	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.
Time Frame	From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Silver-coated Catheter	Silicone-coated Catheter
Arm/Group Description	Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter	silicone elastomer-coated latex catheter
Measure Participants	426	428
Number [Participants]	57 9.5%	76 12.9%

8. Other Pre-specified Outcome

Title	Number of Subjects With a sUTI Catheterized for >=48 Hours.
Description	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.
Time Frame	From time of catheterization until 10 days or 48 hours after catheter was removed

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Silver-coated Catheter	Silicone-coated Catheter
Arm/Group Description	Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter	silicone elastomer-coated latex catheter
Measure Participants	426	428
Number [Participants]	37 6.2%	38 6.5%

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	Silver-coated Catheter		Silicone-coated Catheter
Arm/Group Description	Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter		silicone elastomer-coated latex catheter
All Cause Mortality
	Silver-coated Catheter		Silicone-coated Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Silver-coated Catheter		Silicone-coated Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	47/565 (8.3%)		58/568 (10.2%)
Blood and lymphatic system disorders
Anemia	4/565 (0.7%)		4/568 (0.7%)
Thrombocytopenia	1/565 (0.2%)		0/568 (0%)
Cardiac disorders
Atrial Fibrillation	2/565 (0.4%)		4/568 (0.7%)
Cardiac Arrest	1/565 (0.2%)		3/568 (0.5%)
Ventricular Tachycardia	2/565 (0.4%)		2/568 (0.4%)
Cardiac Failure Congestive	1/565 (0.2%)		1/568 (0.2%)
Myocardial Infarction	1/565 (0.2%)		1/568 (0.2%)
Supraventricular Tachycardia	2/565 (0.4%)		0/568 (0%)
Angina Pectoris	0/565 (0%)		1/568 (0.2%)
Bradycardia	0/565 (0%)		1/568 (0.2%)
Cardiac Tamponade	1/565 (0.2%)		0/568 (0%)
Cardio-Respiratory Arrest	1/565 (0.2%)		0/568 (0%)
Right Ventricular Failure	1/565 (0.2%)		0/568 (0%)
Sinus Tachycardia	1/565 (0.2%)		0/568 (0%)
Ventricular Fibrillation	0/565 (0%)		1/568 (0.2%)
Gastrointestinal disorders
Abdominal Distension	0/565 (0%)		1/568 (0.2%)
Constipation	1/565 (0.2%)		0/568 (0%)
Enterocutaneous Fistula	1/565 (0.2%)		0/568 (0%)
Ileus	1/565 (0.2%)		0/568 (0%)
Nausea	1/565 (0.2%)		0/568 (0%)
Retroperitoneal Haematoma	1/565 (0.2%)		0/568 (0%)
Small Intestinal Obstruction	1/565 (0.2%)		0/568 (0%)
General disorders
Chest Pain	0/565 (0%)		1/568 (0.2%)
Multi-Organ Failure	0/565 (0%)		1/568 (0.2%)
Hepatobiliary disorders
Hepatic Failure	0/565 (0%)		1/568 (0.2%)
Infections and infestations
Sepsis	2/565 (0.4%)		3/568 (0.5%)
Septic Shock	2/565 (0.4%)		1/568 (0.2%)
Bronchitis	0/565 (0%)		1/568 (0.2%)
Injury, poisoning and procedural complications
Postoperative Ileus	1/565 (0.2%)		2/568 (0.4%)
Abdominal Wound Dehiscence	1/565 (0.2%)		1/568 (0.2%)
Anastomotic Leak	1/565 (0.2%)		1/568 (0.2%)
Reocclusion	1/565 (0.2%)		0/568 (0%)
Wound Dehiscence	1/565 (0.2%)		0/568 (0%)
Investigations
Blood Amylase Increased	1/565 (0.2%)		0/568 (0%)
Blood Creatine Increased	1/565 (0.2%)		0/568 (0%)
Lipase Increased	1/565 (0.2%)		0/568 (0%)
Metabolism and nutrition disorders
Hypokalaemia	1/565 (0.2%)		0/568 (0%)
Lactic Acidosis	0/565 (0%)		1/568 (0.2%)
Musculoskeletal and connective tissue disorders
Mobility Decreased	1/565 (0.2%)		0/568 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia	1/565 (0.2%)		0/568 (0%)
Nervous system disorders
Cerebrovascular Accident	1/565 (0.2%)		1/568 (0.2%)
Cerebellar Haemorrhage	1/565 (0.2%)		0/568 (0%)
Encephalopathy	0/565 (0%)		1/568 (0.2%)
Syncope Vasovagal	1/565 (0.2%)		0/568 (0%)
Psychiatric disorders
Mental Status Changes	1/565 (0.2%)		1/568 (0.2%)
Alcohol Withdrawal Syndrome	1/565 (0.2%)		0/568 (0%)
Renal and urinary disorders
Renal Failure	1/565 (0.2%)		1/568 (0.2%)
Renal Failure Acute	1/565 (0.2%)		1/568 (0.2%)
Acute Prerenal Failure	0/565 (0%)		1/568 (0.2%)
Haematuria	1/565 (0.2%)		0/568 (0%)
Renal Tubular Necrosis	0/565 (0%)		1/568 (0.2%)
Urinary Retention	1/565 (0.2%)		0/568 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	7/565 (1.2%)		14/568 (2.5%)
Respiratory Distress	2/565 (0.4%)		1/568 (0.2%)
Acute Respiratory Failure	0/565 (0%)		1/568 (0.2%)
Aspiration	1/565 (0.2%)		0/568 (0%)
Atelectasis	0/565 (0%)		1/568 (0.2%)
Chylothorax	0/565 (0%)		1/568 (0.2%)
Increased Bronchial Secretion	0/565 (0%)		1/568 (0.2%)
Interstitial Lung Disease	0/565 (0%)		1/568 (0.2%)
Obstructive Airways Disorder	0/565 (0%)		1/568 (0.2%)
Pneumothorax	0/565 (0%)		1/568 (0.2%)
Tachypnoea	0/565 (0%)		1/568 (0.2%)
Skin and subcutaneous tissue disorders
Angioedema	1/565 (0.2%)		0/568 (0%)
Surgical and medical procedures
Wound Drainage	0/565 (0%)		1/568 (0.2%)
Vascular disorders
Hypotension	2/565 (0.4%)		1/568 (0.2%)
Hypertension	2/565 (0.4%)		0/568 (0%)
Haemorrhage	0/565 (0%)		1/568 (0.2%)
Shock	1/565 (0.2%)		0/568 (0%)
Other (Not Including Serious) Adverse Events
	Silver-coated Catheter		Silicone-coated Catheter
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/565 (2.7%)		29/568 (5.1%)
Renal and urinary disorders
Haematuria	12/565 (2.1%)		15/568 (2.6%)
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	7/565 (1.2%)		14/568 (2.5%)

Limitations/Caveats

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).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.