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Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients (ESCALE)

Primary Purpose

Urinary Tract Infection

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Silver Alloy-Coated Urinary Catheters
Conventional Urinary Catheter
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infection focused on measuring Spinal cord injuries, Urinary tract infection, Urinary catheters, Protocol, Randomized clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Sites / Locations

  • Mutual de la Seguridad Chilena
  • Azienda Ospedaliero-Universitaria - Ospedali Riuniti di Ancona - Unità Spinale
  • Azienda Ospedaliero-Universitaria Policlinico di Bari- Unità Operativa di Medicina Fisica e Riabilitazione e Unità Spinale Unipolare
  • Unità Operative Recupero e Riabilitazione Funzionale e Gravi Cerebrolesioni Acquisite
  • Unità Spinale Unipolare
  • Centro de Medicina de Reabilitação de Alcoitão
  • Centro Clínico Académico - Braga, Associação (2CA-Braga)
  • Centro Hospitalar do Porto
  • Hospital Universitario Central de Asturias
  • Hospital de Neurorrehabilitación Instituto Guttmann
  • Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias
  • Hospital Universitario Cruces
  • Complexo Hospitalario Universitario A Coruña
  • Hospital Universitario Puerta del Mar
  • Hospital Universitario La Paz
  • Hospital Universitario Virgen del Rocío
  • Hospital Nacional de Parapléjicos
  • Hospital Universitario Miguel Servet
  • Dokuz Eylul University Dept. of Physical Medicine and Rehabilitation
  • Ege University Dept. of Physical Medicine and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Silver Alloy-Coated Urinary Catheters

Conventional Urinary Catheter

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 26, 2013
Last Updated
September 19, 2016
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Asociacion Colaboracion Cochrane Iberoamericana, European Clinical Research Infrastructure Network
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1. Study Identification

Unique Protocol Identification Number
NCT01803919
Brief Title
Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients
Acronym
ESCALE
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruitment
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Asociacion Colaboracion Cochrane Iberoamericana, European Clinical Research Infrastructure Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Spinal cord injuries, Urinary tract infection, Urinary catheters, Protocol, Randomized clinical trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
489 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silver Alloy-Coated Urinary Catheters
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Urinary Catheter
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Silver Alloy-Coated Urinary Catheters
Other Intervention Name(s)
BIP Foley catheter - Silicone Bactiguard Infection Protection
Intervention Type
Device
Intervention Name(s)
Conventional Urinary Catheter
Other Intervention Name(s)
Foley silicona 100% (16 or 18 Ch), Foley Rüsch (16 or 18 Ch), Foley Bardex (16 or 18 Ch), Folysil (16 or 18 Ch), Foley Rochester (16 or 18 Ch), Foley Euromedical (16 or 18 Ch)
Primary Outcome Measure Information:
Title
Incidence of catheter associated urinary tract infection
Description
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).
Time Frame
at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Secondary Outcome Measure Information:
Title
Asymptomatic urinary tract infection
Description
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.
Time Frame
at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Title
Bacteremic urinary tract infection
Description
Those with the primary outcome and with a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.
Time Frame
at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
Other Pre-specified Outcome Measures:
Title
Direct costs
Description
Calculation of direct costs attributable to the use of intervention or control urinary catheters and their complications
Time Frame
From catheterization procedure and 30th day, catheter removal or catheter replacement or finalization of complication(s) or related treatment(s), whichever last longer.
Title
Number of participants with adverse events related to catheterization as a Measure of Safety and Tolerability
Description
Any untoward medical occurrence related to urinary catheterization
Time Frame
at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Bonfill, MD, PhD
Organizational Affiliation
Asociacion Colaboracion Cochrane Iberoamericana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mutual de la Seguridad Chilena
City
Santiago de Chile
ZIP/Postal Code
4848
Country
Chile
Facility Name
Azienda Ospedaliero-Universitaria - Ospedali Riuniti di Ancona - Unità Spinale
City
Ancona
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico di Bari- Unità Operativa di Medicina Fisica e Riabilitazione e Unità Spinale Unipolare
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Unità Operative Recupero e Riabilitazione Funzionale e Gravi Cerebrolesioni Acquisite
City
Ceglie Messapica
ZIP/Postal Code
72013
Country
Italy
Facility Name
Unità Spinale Unipolare
City
Rome
ZIP/Postal Code
00142
Country
Italy
Facility Name
Centro de Medicina de Reabilitação de Alcoitão
City
Alcoitão
State/Province
Alcabideche
ZIP/Postal Code
2649-506
Country
Portugal
Facility Name
Centro Clínico Académico - Braga, Associação (2CA-Braga)
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Hospital de Neurorrehabilitación Instituto Guttmann
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
Country
Spain
Facility Name
Hospital Universitario Cruces
City
Barakaldo
State/Province
Vizcaya
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruña
City
A Coruña
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain
Facility Name
Hospital Nacional de Parapléjicos
City
Toledo
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
Country
Spain
Facility Name
Dokuz Eylul University Dept. of Physical Medicine and Rehabilitation
City
Alsancak
State/Province
Izmir
ZIP/Postal Code
35210
Country
Turkey
Facility Name
Ege University Dept. of Physical Medicine and Rehabilitation
City
Bornova
State/Province
İzmir
ZIP/Postal Code
35040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
23895463
Citation
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.
Results Reference
background

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Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients

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