Peritoneal Dialysis-associated PeritonitisPhase 3NCT03046511
Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.
A Phase 3 study testing Cefazolin in people with Peritoneal Dialysis-associated Peritonitis and Peritoneal Dialysis Catheter Infection, run by Carmel Medical Center at 1 site in Israel.
Trial summary
An intraperitoneal implanted catheter is always necessary to perform Peritoneal Dialysis. Catheter insertion has been associated with infectious complication such as Exit Site Infection (ESI), Tunnel Infection and Peritonitis. The last one may lead to loss of the technique because the need of catheter removal. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peritoneal Dialysis-associated Peritonitis, Peritoneal Dialysis Catheter Infection, Peritoneal Dialysis Complication
- What is being tested?
- Cefazolin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Mar 2017to 31 Dec 2023
- Phase
- Phase 3
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects suffering from Chronic Kidney Disease, candidates to a intra- peritoneal catheter insertion
Who cannot join
- Pregnancy; Active antibiotic treatment before the procedure; Known allergy to Cefazolin
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa, 34362
Victor Frajewicki, MD, +97248250491, vfraje@clalit.org.il
Tatiana Tanasiychuk, MD, +97248250954, TatianaTa1@clalit.org.il
About this study
Official title: Comparison Between Post - Surgical Intraperitoneal Antibiotics Administration Vs. Intravenous Pre- Surgical Administration for the Prevention of Peritonitis After Insertion of Peritoneal Dialysis Catheter in Peritoneal Dialysis Patients
An intraperitoneal implanted catheter is always necessary to perform Peritoneal Dialysis. Catheter insertion has been associated with infectious complication such as Exit Site Infection (ESI), Tunnel Infection and Peritonitis. The last one may lead to loss of the technique because the need of catheter removal. Most of international guidelines recommends the use of prophylactic antibiotics. Different protocols has been used, mostly intravenous single injection before the procedure. For the last 25 years our unit gives a single intraperitoneal dose of Cefazolin immediately after the catheter insertion. The aim of this study is compare the effect of a pre- operative IV dose os Cefazolin with a post- procedure intraperitoneal single dose administration of the same drug.
- Conditions
- Peritoneal Dialysis-associated Peritonitis, Peritoneal Dialysis Catheter Infection, Peritoneal Dialysis Complication
- Being tested
- Cefazolin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
A post- procedure administration of Cefazolin will be compared with a pre-operative intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal | Experimental | One single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter Receives: Drug: Cefazolin |
| Intravenous | Active comparator | One single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritonitis
Peritonitis asscociated catheter defined by cloudy effluent, high leukocyte count with neutrofilia
Measured: 14 days
Secondary outcomes (2)
Exit site infection
Infection defined by purulent discharge or local redness
Measured: 14 days
Tunnel infection
Inflammation in the subcutaneous tract of the peritoneal catheter
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start8 Mar 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis-associated PeritonitisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Frajewicki, MD, Carmel Medical Center
- Investigators
- Victor Frajewicki, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046511
- Sponsor's protocol ID
- CMC-16-0067-CTIL
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2017
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Post - Surgical Intraperitoneal Antibiotics Administration Vs. Intravenous Pre- Surgical Administration for the Prevention of Peritonitis After Insertion of Peritoneal Dialysis Catheter in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT03046511
- Acronym / sponsor ID
- CMC-16-0067-CTIL
- Conditions
- Peritoneal Dialysis-associated Peritonitis, Peritoneal Dialysis Catheter Infection, Peritoneal Dialysis Complication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Feb 2017 (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.
An intraperitoneal implanted catheter is always necessary to perform Peritoneal Dialysis. Catheter insertion has been associated with infectious complication such as Exit Site Infection (ESI), Tunnel Infection and Peritonitis. The last one may lead to loss of the technique because the need of catheter removal. Most of international guidelines recommends the use of prophylactic antibiotics. Different protocols has been used, mostly intravenous single injection before the procedure. For the last 25 years our unit gives a single intraperitoneal dose of Cefazolin immediately after the catheter insertion. The aim of this study is compare the effect of a pre- operative IV dose os Cefazolin with a post- procedure intraperitoneal single dose administration of the same drug.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal | Experimental | Drug: CefazolinOne single dose of intraperitoneal Cefazolin 1000 mg via the recently inserted peritoneal catheter |
| Intravenous | Active comparator | Drug: CefazolinOne single dose of intravenous Cefazolin 1000 mg one hour before catheter insertion |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects suffering from Chronic Kidney Disease, candidates to a intra- peritoneal catheter insertion
Key exclusion criteria (1 listed)
- Pregnancy; Active antibiotic treatment before the procedure; Known allergy to Cefazolin
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 |
|---|---|---|
| CefazolinA post- procedure administration of Cefazolin will be compared with a pre-operative intravenous dose | Drug | Intraperitoneal, Intravenous |
Primary outcome
Peritonitis
Time frame: 14 days
Peritonitis asscociated catheter defined by cloudy effluent, high leukocyte count with neutrofilia
2 secondary outcomes
Exit site infection
Time frame: 14 days
Tunnel infection
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Dialysis-associated Peritonitis
RecruitingObservational study
Peritoneal Dialysis Registration System (PERSIST)
ESRD, Disorders Associated With Peritoneal Dialysis
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.
Victor Frajewicki, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cefazolin in people with Peritoneal Dialysis-associated Peritonitis and Peritoneal Dialysis Catheter Infection, run by Carmel 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 1 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 13 Feb 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Victor Frajewicki, MD (972-4-8250491, vfraje@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritonitis (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2023.