Phage Safety Cohort Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phage Safety Cohort Study

Conditions
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Prosthetic Joint Infection, Severe Infection

Intervention / Treatment
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* Other: Adverse event after injection of phages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 18 years of age or older with a serious infection treated at CRIOAc Lyon by phage therapy Patient who did not object to participating in the study Patients ayant un poids minimum de 46kg Exclusion Criteria: Patients under guardianship/curatorship Patients deprived of liberty Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PHA SA CO<br>patients having a severe infection treated by injection of phages, with or without surgery | Other: Adverse event after injection of phages<br>* rate and description of adverse event after injection of phages<br>|
| PhageRESPONSE<br>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. | Other: Adverse event after injection of phages<br>* rate and description of adverse event after injection of phages<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phage, adverse event, severe infection, compassionate treatment