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

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Infection

Treatments: Drug: CITA-RNPT; Procedure: Extraction of infected CIED

Study type: Interventional

Funder types: Other

Identifiers

NCT01770067

0093-12-HYMC

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• High-risk patients for CIED infections
• CIED infections

Exclusion criteria

• Systematic infection

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Infected CIED and Infection-Prone Patients Prior to CIED Implantation

Experimental group

Description:

Administration of high-dose antibiotics (CITA)

Treatment:

Drug: CITA-RNPT

Infected CIED extraction

Active Comparator group

Description:

Extraction of infected CIED

Treatment:

Procedure: Extraction of infected CIED