CatheterizationPhase 4SUCCESSNCT00482547

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

A Phase 4 study testing Hydrogel Silver Salts Coated Latex Urinary Catheter System and Bard silicone elastomer coated latex catheter system in people with Catheterization, run by C. R. Bard at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Catheterization
What is being tested?: Hydrogel Silver Salts Coated Latex Urinary Catheter System and Bard silicone elastomer coated latex catheter system
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,188 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Aug 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Henry Ford Hospital
Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: Study of a Urethral Catheter Coated With Eluting Silver Salts

Read the 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).

Conditions: Catheterization
Being tested: Hydrogel Silver Salts Coated Latex Urinary Catheter System, Bard silicone elastomer coated latex catheter system
Keywords: urinary tract infection, urinary catheter
Medical subject headings: Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hydrogel Silver Salts Coated Latex Urinary Catheter SystemDevice
Also called AgSC arm
Silver-coated catheter
Bard silicone elastomer coated latex catheter systemDevice
Also called SiCS arm
Silicone-coated catheter

Study groups in NCT00482547
Study group	Role	What they receive
Silver-coated catheter	Experimental	Bard Hydrogel Silver Salts Coated Latex Urinary Catheter System Receives: Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System
Silicone-coated catheter	Placebo comparator	Bard silicone elastomer coated latex catheter system Receives: Device: Bard silicone elastomer coated latex catheter system

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: >=48 hours to 10 days

Secondary outcomes (5)

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.
Measured: >=48 hours to 10 days
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.
Measured: >= 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.
Measured: >= 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.
Measured: >= 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
Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Aug 2008

First posted5 Jun 2007 (estimated)
Study startJun 2007
Primary completionApr 2008
Study completionAug 2008

Why it stopped: Terminated for futility reasons.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CatheterizationStudies of the same condition, open and under way.
More trials run by C. R. BardThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,188 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00482547
Sponsor's protocol ID: BMD-6003
Acronym: SUCCESS
Status last verified: Jan 2017
First submitted: 4 Jun 2007
Last updated: 28 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of a Urethral Catheter Coated With Eluting Silver Salts
ClinicalTrials.gov ID: NCT00482547
Acronym / sponsor ID: SUCCESS / BMD-6003
Conditions: Catheterization
Keywords: urinary tract infection, urinary catheter
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated for futility reasons.
Enrolment: 1,188 participants (actual)
Lead sponsor: C. R. BardIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Apr 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 5 Jun 2007 (estimated)
Results: Posted 21 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Silver-coated catheter	Experimental	Device: Hydrogel Silver Salts Coated Latex Urinary Catheter SystemBard Hydrogel Silver Salts Coated Latex Urinary Catheter System
Silicone-coated catheter	Placebo comparator	Device: Bard silicone elastomer coated latex catheter systemBard silicone elastomer coated latex catheter system

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydrogel Silver Salts Coated Latex Urinary Catheter SystemAlso: AgSC armSilver-coated catheter	Device	Silver-coated catheter
Bard silicone elastomer coated latex catheter systemAlso: SiCS armSilicone-coated catheter	Device	Silicone-coated catheter

Primary outcome

Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours
Time frame: >=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.

5 secondary outcomes

Percentage of Participants With a bUTI After Catheterization for >= 48 Hours
Time frame: >=48 hours to 10 days
Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours
Time frame: >= 48 hours to 10 days
Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours
Time frame: >= 24 hours to 10 days
Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours
Time frame: >= 24 hours to 10 days
Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL
Time frame: 10 days

Results and safety

Results posted to the registry on 21 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Silver-coated Catheter	599	426
Silicone-coated Catheter	589	428

Primary outcome: Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours

Time frame: >=48 hours to 10 days. Median (Standard Deviation). Unit: Days

Measure	Silver-coated Catheter n = 57	Silicone-coated Catheter n = 76
Value	2.10 (1.99)	2.06 (2.32)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 1.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Silver-coated Catheter	47 of 565 (8.3%)	15 of 565 (2.7%)	Not reported
Silicone-coated Catheter	58 of 568 (10.2%)	29 of 568 (5.1%)	Not reported

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Rupp, MD principal investigator

University of Nebraska

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours (time frame: >=48 hours to 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00482547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.