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.
Study Type
OBSERVATIONAL
Enrollment
100
rate and description of adverse event after injection of phages
Hospices Civils de Lyon
Lyon, France
RECRUITINGtype of adverse event
description of the adverse event
Time frame: 12 months after the injection of phages
rate of adverse event
proportion of patient having an avderse event after injection of phages
Time frame: 12 months after the injection of phages
biobanking PHA SA CO
to assess the role of immunization induced by phage phages in the occurrence of adverse
Time frame: 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
Time frame: from before the injection of phages to 6 months after the injection of phages
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