Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics
Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT01770067
Collaborator
(none)
100
1
2
120
0.8
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
100 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Study Start Date
:
Feb 1, 2013
Anticipated Primary Completion Date
:
Feb 1, 2023
Anticipated Study Completion Date
:
Feb 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Infected CIED and Infection-Prone Patients Prior to CIED Implantation Administration of high-dose antibiotics (CITA) |
Drug: CITA-RNPT
|
| Active Comparator: Infected CIED extraction Extraction of infected CIED |
Procedure: Extraction of infected CIED
|
Outcome Measures
Primary Outcome Measures
- Lack of CIED Infection [One year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
15 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
High-risk patients for CIED infections
-
CIED infections
Exclusion Criteria:
- Systematic infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tel Aviv Medical Center | Tel Aviv | Israel |
Sponsors and Collaborators
- Hillel Yaffe Medical Center
Investigators
- Principal Investigator: Moris Topaz, MD, PhD, Tel Aviv Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01770067
Other Study ID Numbers:
- 0093-12-HYMC
First Posted:
Jan 17, 2013
Last Update Posted:
Feb 9, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hillel Yaffe Medical Center