Patients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related InfectionPhase 1CATH-GENCT04789928
Conservative Treatment of Catheter - Related Injections With Gentamicine/EDTA
A Phase 1 study testing Gentamicins-EDTA in people with Patients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related Infection, run by Institut Pasteur at 6 sites in France.
Trial summary
Catheter-related infections are frequent. Treatment without catheter removal is difficult because of the presence of biofilm. The association of gentamicin and EDTA is active in vitro and in vivo against biofilms formed by Gram positive and Gram negative bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related Infection
- What is being tested?
- Gentamicins-EDTA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 6 sitesFrance
- Study dates
- 5 Jan 2021to 1 Mar 2024
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (≥18 year-old);
- LTIVC in place (TIVAP or single-line tunnelled catheter);
- LTIVC is functional (it is possible to inject an infusate, but also to draw blood from the catheter);
- LTIVC-related bloodstream infection defined by a positive qualitative paired blood culture with a differential time to positivity ≥ 2 hours (meaning that the culture of the blood drawn from the catheter is positive at least 2 hours before the culture of the blood drawn from a peripheral vein);
- Mono microbial infection caused by coagulase-negative staphylococci, Enterobacteriaceae or Pseudomonas aeruginosa;
- Bacterial strain is susceptible toward gentamicin;
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- Life expectancy ≥ 3 months;
- Physician in charge of the patient agrees to perform a conservative treatment;
- Calculated creatinine clearance ≥ 30 mL/min;
- Patient's informed and written consent is collected.
- For women of reproductive age: available beta-HCG dosage (with negative result) < 72h.
- Non-inclusion criteria:
- A patient should not be included if he presents any of the following criteria:
- Presence of any systemic complication (sepsis or septic shock, as defined by the sepsis-3 guidelines), or local complications (tunnel or port-pocket infection, thrombophlebitis, endocarditis, bone and joint infections related to the LTIVC-related BSI);
- Allergy toward aminoglycosides
- PICC-line or hemodialysis tunnelled catheter; LTIVC removal is planned within the following 3 months or LTIVC is not required for the management of the patient's underlying medical condition anymore;
- Diagnosis of LTIVC-related bloodstream infection has been made more than 3 days ago (e.g. >72 hours between the day the first blood culture drawn from the LTIVC is positive and screening visit);
- Systemic treatment of LTIVC-related bloodstream infection includes aminoglycosides (defined as a recent (<36 hours before screening visit) or ongoing systemic injection of aminoglycosides);
- Low blood ionized calcium level (<1,15 μmol/L) before injecting the first dose of genta-EDTA-Na2 lock;
- Presence of prosthetic heart valve, pacemaker or implantable defibrillator;
- The LTIVC has been inserted less than 14 days ago;
- Available Count blood cells < 72h with severe neutropenia (<500 polymorphonuclear cells/mm3);
- Subject with infection caused by Staphylococcus Aureus orCandida-spp;
- The patient is not expected to remain in hospital for at least 7 days after inclusion.
- The administration of the lock according to the protocol (24 hours/day for 48 hours and then at least 12 hours/24 hours for 5 to 8 days) is not possible.
- Decision by the referring physician to prescribe a preventive lock following curative Gentamicin-EDTA treatment (secondary prevention), between the end of treatment (D6/D9) and the D40 follow-up visit.
- Previous inclusion in a study or another therapeutic protocol requiring continuous use of the catheter
- Pregnant and breastfeeding woman;
- Protected adult subject.
- Inability to perform a blood peripheral venous sampling
Who cannot join
- A patient should be excluded if he presents any of the following criteria:
- Presence of local or systemic complication seen on venous ultrasound performed between D2 and D5 or transthoracic echocardiography performed between Day 2 and Day 7 (D2-D7);
- GFR < 30 ml/min (between D0 and D6/9).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Hospitalier Intercommunal de Créteil
Créteil
HEGP
Paris
Hôpital Henri Mondor
Paris
Hôpital Saint-Louis
Paris, Île-de-France Region, 75010
Hôpital Cochin
Paris, Île-de-France Region, 75014
Hôpital Beaujon
Paris, Île-de-France Region, 92000
About this study
Official title: Gentamicine-EDTA, a New Anti-biofilm Strategy for the Conservative Treatment of Catheter-related Infections
Catheter-related infections are frequent. Treatment without catheter removal is difficult because of the presence of biofilm. The association of gentamicin and EDTA is active in vitro and in vivo against biofilms formed by Gram positive and Gram negative bacteria.
- Conditions
- Patients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related Infection
- Being tested
- Gentamicins-EDTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentamicins-EDTADrug
Patients included in this study will receive daily injection (up to 10 days) of genta-EDTA-Na2 lock associated with systemic antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Patients with uncomplicated LTIVC-related BSI and eligible | Experimental | Patients included in this study will receive daily injection of genta-EDTA-Na2 lock associated with systemic antibiotics. Receives: Drug: Gentamicins-EDTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical efficacy is assessed by the frequency of clinical and microbial cure after 30 days of follow-up after the end of treatment (D40)
Resolution of clinical signs at the end of treatment (D6 if the patient already received 72h of a previous active lock before inclusion or D9 if he received a complete 10-day course of genta-EDTA-Na2 locks) and 30 days after completion of therapy (D40)
Measured: 30 days of follow-up after the end of treatment (D40)
Secondary outcomes (1)
The long-term clinical efficacy is assessed by the frequency of microbial cure after 90 days of follow-up after the end of treatment.
Absence of microbial relapse (BSI with the same microbial pathogen, i.e. same species and same antibiotic susceptibility pattern) between D6-D9 and D100;
Measured: after 90 days of follow-up after the end of treatment (D100)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start5 Jan 2021
- Primary completion31 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related InfectionStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot phase, non-comparative, non-randomized, multicentric study on 35 patients with uncomplicated LTIVC-related BSI and eligible for a conservative treatment
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Lebeaux, Principal investigator, Hôpital Européen Georges Pompidou AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789928
- Sponsor's protocol ID
- 2017-003
- Acronym
- CATH-GE
- Status last verified
- Jul 2023
- First submitted
- 4 Jan 2021
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gentamicine-EDTA, a New Anti-biofilm Strategy for the Conservative Treatment of Catheter-related Infections
- ClinicalTrials.gov ID
- NCT04789928
- Acronym / sponsor ID
- CATH-GE / 2017-003
- Conditions
- Patients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 10 Mar 2021 (actual)
- 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.
Catheter-related infections are frequent. Treatment without catheter removal is difficult because of the presence of biofilm. The association of gentamicin and EDTA is active in vitro and in vivo against biofilms formed by Gram positive and Gram negative bacteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot phase, non-comparative, non-randomized, multicentric study on 35 patients with uncomplicated LTIVC-related BSI and eligible for a conservative treatment
| Arm | Type | Receives |
|---|---|---|
| Patients with uncomplicated LTIVC-related BSI and eligible | Experimental | Drug: Gentamicins-EDTAPatients included in this study will receive daily injection of genta-EDTA-Na2 lock associated with systemic antibiotics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Adult patient (≥18 year-old);
- LTIVC in place (TIVAP or single-line tunnelled catheter);
- LTIVC is functional (it is possible to inject an infusate, but also to draw blood from the catheter);
- LTIVC-related bloodstream infection defined by a positive qualitative paired blood culture with a differential time to positivity ≥ 2 hours (meaning that the culture of the blood drawn from the catheter is positive at least 2 hours before the culture of the blood drawn from a peripheral vein);
- Mono microbial infection caused by coagulase-negative staphylococci, Enterobacteriaceae or Pseudomonas aeruginosa;
Key exclusion criteria (3 listed)
- Presence of local or systemic complication seen on venous ultrasound performed between D2 and D5 or transthoracic echocardiography performed between Day 2 and Day 7 (D2-D7);
- GFR < 30 ml/min (between D0 and D6/9).
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 |
|---|---|---|
| Gentamicins-EDTAPatients included in this study will receive daily injection (up to 10 days) of genta-EDTA-Na2 lock associated with systemic antibiotics. | Drug | Patients with uncomplicated LTIVC-related BSI and eligible |
Primary outcome
The clinical efficacy is assessed by the frequency of clinical and microbial cure after 30 days of follow-up after the end of treatment (D40)
Time frame: 30 days of follow-up after the end of treatment (D40)
Resolution of clinical signs at the end of treatment (D6 if the patient already received 72h of a previous active lock before inclusion or D9 if he received a complete 10-day course of genta-EDTA-Na2 locks) and 30 days after completion of therapy (D40)
1 secondary outcome
The long-term clinical efficacy is assessed by the frequency of microbial cure after 90 days of follow-up after the end of treatment.
Time frame: after 90 days of follow-up after the end of treatment (D100)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: Undecided
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.
David Lebeaux principal investigator
Hôpital Européen Georges Pompidou AP-HP
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gentamicins-EDTA in people with Patients With Uncomplicated Long-term Central Venous Catheter-related Biofilm-related Infection, run by Institut Pasteur at 6 sites in France.
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 30 inclusion and 3 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: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical efficacy is assessed by the frequency of clinical and microbial cure after 30 days of follow-up after the end of treatment (D40) (time frame: 30 days of follow-up after the end of treatment (D40)). 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 5 Jun 2024.