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This cohort study aims to describe the adverse events related to the use of bacteriophages to treat serious infections, data from the literature being almost non-existent on this subject.
All potential serious adverse events in compassionate cases will be collected, and classified as potentially related to surgery, to antibiotics, or to phages, with the help of the HCL pharmacovigilance center. In addition, biobanking of pre- and post-treatment blood specimens (bloods, serums and cells) will determine whether phage immunization is implicated in particular adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PHA SA CO | patients having a severe infection treated by injection of phages, with or without surgery |
| |
| PhageRESPONSE | ancillary study : Establish a biobanking of serums, plasmas and PBMC (Peripheral Blood Mononuclear Cells) of patients who have been treated with phage therapy for a bacterial infection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adverse event after injection of phages | Other | rate and description of adverse event after injection of phages |
|
| Measure | Description | Time Frame |
|---|---|---|
| type of adverse event | description of the adverse event | 12 months after the injection of phages |
| rate of adverse event | proportion of patient having an avderse event after injection of phages | 12 months after the injection of phages |
| Measure | Description | Time Frame |
|---|---|---|
| biobanking PHA SA CO | to assess the role of immunization induced by phage phages in the occurrence of adverse | from before the injection of phages to 6 months after the injection of phages |
| biobanking PhageRESPONSE |
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Inclusion Criteria:
Exclusion Criteria:
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patients having a severe infection treated by injection of phages at the CRIOAC Lyon, Croix-Rousse Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johanna Boulant, CRA | Contact | 04 26 73 29 38 | johanna.boulant@chu-lyon.fr | |
| Tristan Ferry, Md,PhD | Contact | 04 26 73 29 38 | tristan.ferry@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Recruiting | Lyon | 69004 | France |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007239 | Infections |
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PBMC, serums, plasmas
Characterize the cellular and humoral immune response in patients with a severe bacterial infection requiring treatment compassionate by bacteriophage
| from before the injection of phages to 6 months after the injection of phages |