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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01770067

Enrollment

100

Registered

2013-01-17

Start date

2013-02-28

Completion date

2023-02-28

Last updated

2022-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

Cardiac Resynchronization Therapy Devices

Brief summary

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.

Interventions

DRUGCITA-RNPT

PROCEDUREExtraction of infected CIED

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* High-risk patients for CIED infections * CIED infections

Exclusion criteria

* Systematic infection

Design outcomes

Primary

Measure	Time frame
Lack of CIED Infection	One year

Countries

Israel

Contacts

Primary ContactMoris Topaz, MD, PhD

topazmd@netvision.net.il972505251122

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026