Urinary Tract InfectionESCALENCT01803919
Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients
A study testing Silver Alloy-Coated Urinary Catheters and Conventional Urinary Catheter in people with Urinary Tract Infection, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 20 sites in 5 countries.
Trial summary
The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Silver Alloy-Coated Urinary Catheters and Conventional Urinary Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Nov 2012to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 patients with traumatic or medical spinal cord injury
- Age of 18 years or above
- Patients who need an indwelling urinary catheter as a method of bladder drainage for at least 7 days.
- Patients who are willing to participate in the study and give their written informed consent (If a patient is unable to give written consent because of physical or mental disability, an affirmation of consent will be taken in his presence from his relative or legal guardian).
Who cannot join
- Patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage, reflex voiding or use of an external collector.
- Patients with urinary tract infection at the moment of inclusion
- Current antibiotic use or use within 7 days prior to inclusion
- Outpatients with sporadic medical examinations (less than one per month)
- Known allergy to latex, silver salts or hydrogels.
- Patients with surgical interventions in the urinary tract that may interfere, at the investigator criteria, with the study results.
- Pregnant or breastfeeding woman.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Spain10 sites
Complexo Hospitalario Universitario A Coruña
A Coruña, A Coruña
Hospital de Neurorrehabilitación Instituto Guttmann
Badalona, Barcelona
Hospital Universitario Cruces
Barakaldo, Vizcaya
Hospital Universitario Puerta del Mar
Cadiz, Cadiz
Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias
Las Palmas de Gran Canaria, Las Palmas
Hospital Universitario La Paz
Madrid, Madrid
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias
Hospital Universitario Virgen del Rocío
Seville, Sevilla
Hospital Nacional de Parapléjicos
Toledo, Toledo
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza
Italy4 sites
Azienda Ospedaliero-Universitaria - Ospedali Riuniti di Ancona - Unità Spinale
Ancona
Azienda Ospedaliero-Universitaria Policlinico di Bari- Unità Operativa di Medicina Fisica e Riabilitazione e Unità Spinale Unipolare
Bari, 70124
Unità Operative Recupero e Riabilitazione Funzionale e Gravi Cerebrolesioni Acquisite
Ceglie Messapica, 72013
Unità Spinale Unipolare
Rome, 00142
Portugal3 sites
Centro de Medicina de Reabilitação de Alcoitão
Alcoitão, Alcabideche, 2649-506
Centro Clínico Académico - Braga, Associação (2CA-Braga)
Braga, 4710-243
Centro Hospitalar do Porto
Porto, 4099-001
Turkey (Türkiye)2 sites
Dokuz Eylul University Dept. of Physical Medicine and Rehabilitation
Alsancak, İzmir, 35210
Ege University Dept. of Physical Medicine and Rehabilitation
Bornova, İzmir, 35040
About this study
Official title: Multicentric, Controlled, Randomized Clinical Trial to Assess the Efficacy and Cost-effectiveness of Urinary Catheters With Silver Alloy Coating Versus Conventional Catheters in Spinal Cord Injured Patients
The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.
Read the detailed description
Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce urinary tract infections; however, research evidence cannot be extrapolated to spinal cord injured patients.
The study is an open, randomized, multicentric, and parallel clinical trial with blinded assessment. The study includes spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants are on-line centrally randomized and allocated to one of the two interventions (Antiseptic Urinary Catheters or Conventional Catheters). Catheters are used for a maximum period of 30 days or removed earlier at the clinician criteria.
The main outcome is the incidence of urinary tract infections by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients.
The aim of this study is to assess whether silver alloy-coated silicone urinary catheters reduce urinary infections in spinal cord injured patients.
- Conditions
- Urinary Tract Infection
- Being tested
- Silver Alloy-Coated Urinary Catheters, Conventional Urinary Catheter
- Keywords
- Spinal cord injuries, Urinary tract infection, Urinary catheters, Protocol, Randomized clinical trial
- Medical subject headings
- Urinary Tract Infections, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Alloy-Coated Urinary CathetersDevice
Also called BIP Foley catheter - Silicone Bactiguard Infection Protection
Conventional Urinary CatheterDevice
Also called Foley silicona 100% (16 or 18 Ch), Foley Rüsch (16 or 18 Ch), Foley Bardex (16 or 18 Ch), Folysil (16 or 18 Ch)
| Study group | Role | What they receive |
|---|---|---|
| Silver Alloy-Coated Urinary Catheters | Experimental | Bactiguard® Infection Protection coating consists of noble metals such as gold, palladium and silver. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study. Receives: Device: Silver Alloy-Coated Urinary Catheters |
| Conventional Urinary Catheter | Other | Conventional or standard urinary catheters are those commonly used in each study center, most of them made of silicone or silicone-latex. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study. Receives: Device: Conventional Urinary Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter associated urinary tract infection
Is considered that a patient suffer a urinary tract infection if they have at least one suggestive sign or symptom with no other recognized cause and a positive urine culture with no more than 2 species of microorganisms.
An urinary tract infection is considered catheter associated if the specimen collection is performed at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first).
Measured: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Secondary outcomes (2)
Asymptomatic urinary tract infection
A positive urine culture with no more than 2 species of microorganisms(collected at any time from catheterization procedure and 30th day, catheter removal or catheter replacement, whichever occurs first), and no signs or symptoms.
Measured: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Bacteremic urinary tract infection
Those with the primary outcome and with a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.
Measured: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2015
- Study completionJan 2016
Why it stopped: Difficulties in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Asociacion Colaboracion Cochrane Iberoamericana, European Clinical Research Infrastructure Network
- Responsible party
- Sponsor
- Investigators
- Xavier Bonfill, MD, PhD, Principal investigator, Asociacion Colaboracion Cochrane Iberoamericana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803919
- Sponsor's protocol ID
- IIBSP-SUR-2011-68
- Other IDs
- 112210
- Acronym
- ESCALE
- Status last verified
- Sep 2016
- First submitted
- 26 Feb 2013
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Bonfill X, Rigau D, Jauregui-Abrisqueta ML, Barrera Chacon JM, de la Barrera SS, Aleman-Sanchez CM, Bea-Munoz M, Moraleda Perez S, Borau Duran A, Espinosa Quiros JR, Ledesma Romano L, Fuertes ME, Araya I, Martinez-Zapata MJ. A randomized controlled trial to assess the efficacy and cost-effectiveness of urinary catheters with silver alloy coating in spinal cord injured patients: trial protocol. BMC Urol. 2013 Jul 30;13:38. doi: 10.1186/1471-2490-13-38.
PubMed 23895463
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Controlled, Randomized Clinical Trial to Assess the Efficacy and Cost-effectiveness of Urinary Catheters With Silver Alloy Coating Versus Conventional Catheters in Spinal Cord Injured Patients
- ClinicalTrials.gov ID
- NCT01803919
- Acronym / sponsor ID
- ESCALE / IIBSP-SUR-2011-68
- Conditions
- Urinary Tract Infection
- Keywords
- Spinal cord injuries, Urinary tract infection, Urinary catheters, Protocol, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruitment
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Asociacion Colaboracion Cochrane Iberoamericana, European Clinical Research Infrastructure Network
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.
Detailed description
Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce urinary tract infections; however, research evidence cannot be extrapolated to spinal cord injured patients.
The study is an open, randomized, multicentric, and parallel clinical trial with blinded assessment. The study includes spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants are on-line centrally randomized and allocated to one of the two interventions (Antiseptic Urinary Catheters or Conventional Catheters). Catheters are used for a maximum period of 30 days or removed earlier at the clinician criteria.
The main outcome is the incidence of urinary tract infections by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients.
The aim of this study is to assess whether silver alloy-coated silicone urinary catheters reduce urinary infections in spinal cord injured patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver Alloy-Coated Urinary Catheters | Experimental | Device: Silver Alloy-Coated Urinary CathetersBactiguard® Infection Protection coating consists of noble metals such as gold, palladium and silver. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study. |
| Conventional Urinary Catheter | Other | Device: Conventional Urinary CatheterConventional or standard urinary catheters are those commonly used in each study center, most of them made of silicone or silicone-latex. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients with traumatic or medical spinal cord injury
- Age of 18 years or above
- Patients who need an indwelling urinary catheter as a method of bladder drainage for at least 7 days.
- Patients who are willing to participate in the study and give their written informed consent (If a patient is unable to give written consent because of physical or mental disability, an affirmation of consent will be taken in his presence from his relative or legal guardian).
Key exclusion criteria (7 listed)
- Patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage, reflex voiding or use of an external collector.
- Patients with urinary tract infection at the moment of inclusion
- Current antibiotic use or use within 7 days prior to inclusion
- Outpatients with sporadic medical examinations (less than one per month)
- Known allergy to latex, silver salts or hydrogels.
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 |
|---|---|---|
| Silver Alloy-Coated Urinary CathetersAlso: BIP Foley catheter - Silicone Bactiguard Infection Protection | Device | Silver Alloy-Coated Urinary Catheters |
| Conventional Urinary CatheterAlso: Foley silicona 100% (16 or 18 Ch), Foley Rüsch (16 or 18 Ch), Foley Bardex (16 or 18 Ch), Folysil (16 or 18 Ch) | Device | Conventional Urinary Catheter |
Primary outcome
Incidence of catheter associated urinary tract infection
Time frame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Is considered that a patient suffer a urinary tract infection if they have at least one suggestive sign or symptom with no other recognized cause and a positive urine culture with no more than 2 species of microorganisms. An urinary tract infection is considered catheter associated if the specimen collection is performed at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first).
2 secondary outcomes
Asymptomatic urinary tract infection
Time frame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Bacteremic urinary tract infection
Time frame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Results and safety
The study was stopped early (reason given: Difficulties in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Background: PubMed 23895463Bonfill X, Rigau D, Jauregui-Abrisqueta ML, Barrera Chacon JM, de la Barrera SS, Aleman-Sanchez CM, Bea-Munoz M, Moraleda Perez S, Borau Duran A, Espinosa Quiros JR, Ledesma Romano L, Fuertes ME, Araya I, Martinez-Zapata MJ. A randomized controlled trial to assess the efficacy and cost-effectiveness of urinary catheters with silver alloy coating in spinal cord injured patients: trial protocol. BMC Urol. 2013 Jul 30;13:38. doi: 10.1186/1471-2490-13-38.
- Individual participant dataSharing planned: Yes
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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.
Xavier Bonfill, MD, PhD principal investigator
Asociacion Colaboracion Cochrane Iberoamericana
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Alloy-Coated Urinary Catheters and Conventional Urinary Catheter in people with Urinary Tract Infection, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 20 sites in 5 countries.
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 4 inclusion and 7 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain, Italy, Portugal, Turkey (Türkiye), Chile. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruitment). Results are not available in the source record.
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?
Incidence of catheter associated urinary tract infection (time frame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)). 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 NCT01803919, which also lists 1 linked publication.
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 20 Sep 2016.