InfectionNCT01770067
Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics
A study testing CITA-RNPT and Extraction of infected CIED in people with Infection, run by Hillel Yaffe Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Infection
- What is being tested?
- CITA-RNPT and Extraction of infected CIED
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- High-risk patients for CIED infections
- CIED infections
Who cannot join
- Systematic infection
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Infection
- Being tested
- CITA-RNPT, Extraction of infected CIED
- Keywords
- Cardiac Resynchronization Therapy Devices
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CITA-RNPTDrug
Extraction of infected CIEDProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Infected CIED and Infection-Prone Patients Prior to CIED Implantation | Experimental | Administration of high-dose antibiotics (CITA) Receives: Drug: CITA-RNPT |
| Infected CIED extraction | Active comparator | Extraction of infected CIED Receives: Procedure: Extraction of infected CIED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lack of CIED Infection
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Moris Topaz, MD, PhD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770067
- Sponsor's protocol ID
- 0093-12-HYMC
- Status last verified
- Jan 2022
- First submitted
- 15 Jan 2013
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36631206
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01770067
- Acronym / sponsor ID
- 0093-12-HYMC
- Conditions
- Infection
- Keywords
- Cardiac Resynchronization Therapy Devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Feb 2013
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infected CIED and Infection-Prone Patients Prior to CIED Implantation | Experimental | Drug: CITA-RNPTAdministration of high-dose antibiotics (CITA) |
| Infected CIED extraction | Active comparator | Procedure: Extraction of infected CIEDExtraction of infected CIED |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- High-risk patients for CIED infections
- CIED infections
Key exclusion criteria (1 listed)
- Systematic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CITA-RNPT | Drug | Infected CIED and Infection-Prone Patients Prior to CIED Implantation |
| Extraction of infected CIED | Procedure or surgery | Infected CIED extraction |
Primary outcome
Lack of CIED Infection
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Derived from this study: PubMed 36631206Topaz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moris Topaz, MD, PhD principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CITA-RNPT and Extraction of infected CIED in people with Infection, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moris Topaz, MD, PhD (972505251122, topazmd@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lack of CIED Infection (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01770067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.