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NCT01770067 Clinical Trial

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

Infection Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01770067
Other study ID # 0093-12-HYMC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2013
Est. completion date February 2023

Study information
Verified date January 2022
Source Hillel Yaffe Medical Center
Contact Moris Topaz, MD, PhD
Phone 972505251122
Email topazmd@netvision.net.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date February 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - High-risk patients for CIED infections - CIED infections Exclusion Criteria: - Systematic infection

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CITA-RNPT

Procedure:
• Extraction of infected CIED

Locations
Country Name City State
Israel Tel Aviv Medical Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lack of CIED Infection One year
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