Phage Safety Cohort Study

NCT04650607 — Recruiting, 100 participants, Hospices Civils de Lyon

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Registry	NCT04650607, acronym PHA-SA-CO
Status	Recruiting
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Hospices Civils de Lyon (Other)
Conditions	Prosthetic Joint Infection, Severe Infection
Interventions	Adverse event after injection of phages (Other)
Dates	start 2022-05-09, primary completion 2023-10-09 (estimated), completion 2028-05-09 (estimated), first posted 2020-12-02, last updated 2023-04-13
Locations	1 site in France

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
PHA SA CO		Other: Adverse event after injection of phages	patients having a severe infection treated by injection of phages, with or without surgery
PhageRESPONSE		Other: Adverse event after injection of phages	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.

Adverse event after injection of phages (Other): rate and description of adverse event after injection of phages

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Hospices Civils de Lyon	Lyon	France	Recruiting