Prosthetic Joint Infection, Severe Infection
Conditions
Keywords
phage, adverse event, severe infection, compassionate treatment
Brief summary
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
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.
Interventions
OTHERAdverse event after injection of phages
rate and description of adverse event after injection of phages
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| type of adverse event | 12 months after the injection of phages | description of the adverse event |
| rate of adverse event | 12 months after the injection of phages | proportion of patient having an avderse event after injection of phages |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| biobanking PHA SA CO | from before the injection of phages to 6 months after the injection of phages | to assess the role of immunization induced by phage phages in the occurrence of adverse |
| biobanking PhageRESPONSE | from before the injection of phages to 6 months after the injection of phages | Characterize the cellular and humoral immune response in patients with a severe bacterial infection requiring treatment compassionate by bacteriophage |
Countries
France
Contacts
Primary ContactJohanna Boulant, CRA
Backup ContactTristan Ferry, Md,PhD
Outcome results
None listed