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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Hillel Yaffe Medical Center Identifier:
First received: January 15, 2013
Last updated: January 16, 2013
Last verified: January 2013
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

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

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)


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01770067

Contact: Moris Topaz, MD, PhD 972-4-630-4689

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

Responsible Party: Hillel Yaffe Medical Center 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 processed this record on October 28, 2016