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

NCT ID: NCT01770067

Last Updated: 2022-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2023-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Infected CIED and Infection-Prone Patients Prior to CIED Implantation

Administration of high-dose antibiotics (CITA)

Group Type EXPERIMENTAL

CITA-RNPT

Intervention Type DRUG

Infected CIED extraction

Extraction of infected CIED

Group Type ACTIVE_COMPARATOR

Extraction of infected CIED

Intervention Type PROCEDURE

Interventions

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CITA-RNPT

Intervention Type DRUG

Extraction of infected CIED

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* High-risk patients for CIED infections
* CIED infections

Exclusion Criteria

* Systematic infection
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moris Topaz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

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Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Moris Topaz, MD, PhD

Role: CONTACT

972505251122

References

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Topaz M, Chorin E, Schwartz AL, Hochstadt A, Shotan A, Ashkenazi I, Kazatsker M, Carmel NN, Topaz G, Oron Y, Margolis G, Nof E, Beinart R, Glikson M, Mazo A, Milman A, Dekel M, Banai S, Rosso R, Viskin S. Regional Antibiotic Delivery for Implanted Cardiovascular Electronic Device Infections. J Am Coll Cardiol. 2023 Jan 17;81(2):119-133. doi: 10.1016/j.jacc.2022.10.022.

Reference Type DERIVED
PMID: 36631206 (View on PubMed)

Other Identifiers

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0093-12-HYMC

Identifier Type: -

Identifier Source: org_study_id

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