Prophylactic Treatment of High-Risk Patients With Cardiovascular Implantable Electronic Devices (CIED)With Continuous In-Situ Ultra High-Dose Antibiotics (CITA) Under Regulated Negative Pressure-Assisted Wound Therapy (RNPT)

This study is not yet open for participant recruitment.
Verified January 2013 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01770067
First received: January 15, 2013
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

Following previous positive experience with CITA-RNPT of infected pacemakers, we suggest that CITA-RNPT can be administered prophylactically to patients prior to replacement of CIED, immun-compromised patients, and others.


Condition Intervention
Infection
Drug: CITA-RNPT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Lack of CIED Infection [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infection Prone Patients Prior to CIED
Administration of high-dose antibiotics (CIA-RNPT)
Drug: CITA-RNPT

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High-risk patients for CIED infections

Exclusion Criteria:

  • All others
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01770067

Contacts
Contact: Moris Topaz, MD, PhD 972-4-630-4689 topazmd@netvision.net.il

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Moris Topaz, MD, PhD Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01770067     History of Changes
Other Study ID Numbers: 0093-12-HYMC
Study First Received: January 15, 2013
Last Updated: January 16, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:
Cardiac Resynchronization Therapy Devices

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014