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

Not Applicable

• Conditions: Infection
• Interventions: Drug: CITA-RNPT; Procedure: Extraction of infected CIED

• Registration Number: NCT01770067
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-17
• Study Start: 2013-02
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-02-09
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• High-risk patients for CIED infections
• CIED infections

Exclusion Criteria

• Systematic infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infected CIED and Infection-Prone Patients Prior to CIED Implantation	CITA-RNPT	Administration of high-dose antibiotics (CITA)
Infected CIED extraction	Extraction of infected CIED	Extraction of infected CIED

Primary Outcome Measures

Name	Time	Method
Lack of CIED Infection	One year

Trial Locations

Locations (1)

Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel