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. (see Contacts and Locations)
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
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: 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 July 22, 2014