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

Urinary Tract Infection Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01803919
• Other study ID #: IIBSP-SUR-2011-68
• Secondary ID: 112210
• Status: Terminated
• Phase: N/A
• First received: February 26, 2013
• Last updated: September 19, 2016
• Start date: November 2012
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteePortugal: Ethics CommitteeChile: Ethics CommitteeTurkey: Ethics CommitteeItaly: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 489
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Device:
• Silver Alloy-Coated Urinary Catheters

• Conventional Urinary Catheter

Locations

Country	Name	City	State
Chile	Mutual de la Seguridad Chilena	Santiago de Chile
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	Unità Operative Recupero e Riabilitazione Funzionale e Gravi Cerebrolesioni Acquisite	Ceglie Messapica
Italy	Unità Spinale Unipolare	Rome
Portugal	Centro de Medicina de Reabilitação de Alcoitão	Alcoitão	Alcabideche
Portugal	Centro Clínico Académico - Braga, Associação (2CA-Braga)	Braga
Portugal	Centro Hospitalar do Porto	Porto
Spain	Complexo Hospitalario Universitario A Coruña	A Coruña
Spain	Hospital de Neurorrehabilitación Instituto Guttmann	Badalona	Barcelona
Spain	Hospital Universitario Cruces	Barakaldo	Vizcaya
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias	Las Palmas de Gran Canaria	Las Palmas
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Nacional de Parapléjicos	Toledo
Spain	Hospital Universitario Miguel Servet	Zaragoza
Turkey	Dokuz Eylul University Dept. of Physical Medicine and Rehabilitation	Alsancak	Izmir
Turkey	Ege University Dept. of Physical Medicine and Rehabilitation	Bornova	Izmir

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Asociacion Colaboracion Cochrane Iberoamericana, European Clinical Research Infrastructure Network

Countries where clinical trial is conducted

Chile,  Italy,  Portugal,  Spain,  Turkey, 

References & Publications (1)

Bonfill X, Rigau D, Jáuregui-Abrisqueta ML, Barrera Chacón JM, de la Barrera SS, Alemán-Sánchez CM, Bea-Muñoz M, Moraleda Pérez S, Borau Duran A, Espinosa Quirós JR, Ledesma Romano L, Fuertes ME, Araya I, Martínez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Direct costs	Calculation of direct costs attributable to the use of intervention or control urinary catheters and their complications	From catheterization procedure and 30th day, catheter removal or catheter replacement or finalization of complication(s) or related treatment(s), whichever last longer.	No
Other	Number of participants with adverse events related to catheterization as a Measure of Safety and Tolerability	Any untoward medical occurrence related to urinary catheterization	at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)	Yes
Primary	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).	at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)	Yes
Secondary	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.	at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)	Yes
Secondary	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.	at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)	Yes

External Links

•   Click here for more information about this study: 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 patient