Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics

January 26, 2022 updated by: Hillel Yaffe Medical Center

Prospective Evaluation of the Efficacy and Safety of Continuous In-situ Ultra High-dose Antibiotics (CITA) and Minimally Invasive Surgery (MIS) Utilizing Regulated Negative Pressure-assisted Wound Therapy (RNPT) in the Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics

Following previous positive experience with regulated CITA-RNPT of infected CIEDs, we suggest increasing the number of recruited patients and that CITA-RNPT can be administered prophylactically to patients prior to replacement of previously treated CIEDs, immuno-compromised patients, and others.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Recruiting
        • Tel Aviv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • High-risk patients for CIED infections
  • CIED infections

Exclusion Criteria:

  • Systematic infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infected CIED and Infection-Prone Patients Prior to CIED Implantation
Administration of high-dose antibiotics (CITA)
Drug: CITA-RNPT
Active Comparator: Infected CIED extraction
Extraction of infected CIED
Procedure: Extraction of infected CIED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lack of CIED Infection
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Moris Topaz, MD, PhD, Tel Aviv Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 17, 2013

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0093-12-HYMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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