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

This study has been terminated.
(Difficulties in recruitment)
Sponsor:
Collaborators:
Asociacion Colaboracion Cochrane Iberoamericana
European Clinical Research Infrastructure Network
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01803919
First received: February 26, 2013
Last updated: September 19, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Urinary Tract Infection
Device: Silver Alloy-Coated Urinary Catheters
Device: Conventional Urinary Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) ] [ Designated as safety issue: Yes ]
    Those with the primary outcome and with a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.


Other Outcome Measures:
  • Direct costs [ 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. ] [ Designated as safety issue: No ]
    Calculation of direct costs attributable to the use of intervention or control urinary catheters and their complications

  • Number of participants with adverse events related to catheterization as a Measure of Safety and Tolerability [ Time Frame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first) ] [ Designated as safety issue: Yes ]
    Any untoward medical occurrence related to urinary catheterization


Enrollment: 489
Study Start Date: November 2012
Study Completion Date: January 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silver Alloy-Coated Urinary Catheters
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.
Device: Silver Alloy-Coated Urinary Catheters
Other Name: BIP Foley catheter - Silicone Bactiguard Infection Protection
Conventional Urinary Catheter
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.
Device: Conventional Urinary Catheter
Other Names:
  • 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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803919

Locations
Chile
Mutual de la Seguridad Chilena
Santiago de Chile, Chile, 4848
Italy
Azienda Ospedaliero-Universitaria - Ospedali Riuniti di Ancona - Unità Spinale
Ancona, Italy
Azienda Ospedaliero-Universitaria Policlinico di Bari- Unità Operativa di Medicina Fisica e Riabilitazione e Unità Spinale Unipolare
Bari, Italy, 70124
Unità Operative Recupero e Riabilitazione Funzionale e Gravi Cerebrolesioni Acquisite
Ceglie Messapica, Italy, 72013
Unità Spinale Unipolare
Rome, Italy, 00142
Portugal
Centro de Medicina de Reabilitação de Alcoitão
Alcoitão, Alcabideche, Portugal, 2649-506
Centro Clínico Académico - Braga, Associação (2CA-Braga)
Braga, Portugal, 4710-243
Centro Hospitalar do Porto
Porto, Portugal, 4099-001
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain
Hospital de Neurorrehabilitación Instituto Guttmann
Badalona, Barcelona, Spain
Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Universitario Puerta del Mar
Cadiz, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Hospital Nacional de Parapléjicos
Toledo, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Turkey
Dokuz Eylul University Dept. of Physical Medicine and Rehabilitation
Alsancak, Izmir, Turkey, 35210
Ege University Dept. of Physical Medicine and Rehabilitation
Bornova, İzmir, Turkey, 35040
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Asociacion Colaboracion Cochrane Iberoamericana
European Clinical Research Infrastructure Network
Investigators
Principal Investigator: Xavier Bonfill, MD, PhD Asociacion Colaboracion Cochrane Iberoamericana
  More Information

Additional Information:
Publications:
Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01803919     History of Changes
Other Study ID Numbers: IIBSP-SUR-2011-68  112210 
Study First Received: February 26, 2013
Last Updated: September 19, 2016
Health Authority: Spain: Ethics Committee
Portugal: Ethics Committee
Chile: Ethics Committee
Turkey: Ethics Committee
Italy: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Spinal cord injuries
Urinary tract infection
Urinary catheters
Protocol
Randomized clinical trial

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on September 23, 2016