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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01770067
Recruitment Status : Unknown
Verified January 2013 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 17, 2013
Last Update Posted : January 17, 2013
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Infection Drug: CITA-RNPT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : February 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: Infection Prone Patients Prior to CIED
Administration of high-dose antibiotics (CIA-RNPT)

Primary Outcome Measures :
  1. Lack of CIED Infection [ Time Frame: Six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • High-risk patients for CIED infections

Exclusion Criteria:

  • All others

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Hillel Yaffe Medical Center Identifier: NCT01770067     History of Changes
Other Study ID Numbers: 0093-12-HYMC
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

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