NCT01770067

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 9, 2022

Status Verified

January 1, 2022

Enrollment Period

10 years

First QC Date

January 15, 2013

Last Update Submit

January 26, 2022

Conditions

Infection

Keywords

Cardiac Resynchronization Therapy Devices

Outcome Measures

Primary Outcomes (1)

  • Lack of CIED Infection

    One year

Study Arms (2)

Infected CIED and Infection-Prone Patients Prior to CIED Implantation

EXPERIMENTAL

Administration of high-dose antibiotics (CITA)

Drug: CITA-RNPT

Infected CIED extraction

ACTIVE COMPARATOR

Extraction of infected CIED

Procedure: Extraction of infected CIED

Interventions

CITA-RNPTDRUG
Infected CIED and Infection-Prone Patients Prior to CIED Implantation
Extraction of infected CIEDPROCEDURE
Infected CIED extraction

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • High-risk patients for CIED infections
  • CIED infections

You may not qualify if:

  • Systematic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (1)

  • Topaz M, Chorin E, Schwartz AL, Hochstadt A, Shotan A, Ashkenazi I, Kazatsker M, Carmel NN, Topaz G, Oron Y, Margolis G, Nof E, Beinart R, Glikson M, Mazo A, Milman A, Dekel M, Banai S, Rosso R, Viskin S. Regional Antibiotic Delivery for Implanted Cardiovascular Electronic Device Infections. J Am Coll Cardiol. 2023 Jan 17;81(2):119-133. doi: 10.1016/j.jacc.2022.10.022.

    PMID: 36631206DERIVED

MeSH Terms

Conditions

Infections

Study Officials

  • Moris Topaz, MD, PhD

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moris Topaz, MD, PhD

CONTACT

972505251122topazmd@netvision.net.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

February 9, 2022

Record last verified: 2022-01

Locations

IL(1)