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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentamicins-EDTA | Drug | Patients included in this study will receive daily injection (up to 10 days) of genta-EDTA-Na2 lock associated with systemic antibiotics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 days of follow-up after the end of treatment (D40) |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | after 90 days of follow-up after the end of treatment (D100) |
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Inclusion Criteria:
Non-inclusion criteria:
A patient should not be included if he presents any of the following criteria:
Exclusion criteria
A patient should be excluded if he presents any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Lebeaux | Hôpital Européen Georges Pompidou AP-HP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal de Créteil | Créteil | France | ||||
| HEGP |
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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
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| Paris |
| France |
| Hôpital Henri Mondor | Paris | France |
| Hôpital Saint-Louis | Paris | Île-de-France Region | 75010 | France |
| Hôpital Cochin | Paris | Île-de-France Region | 75014 | France |
| Hôpital Beaujon | Paris | Île-de-France Region | 92000 | France |