PHA-SA-CO: Phage Safety Cohort Study

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04650607

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prosthetic Joint Infection Severe Infection	Other: Adverse event after injection of phages

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Phage Safety Cohort Study

Actual Study Start Date :

May 9, 2022

Anticipated Primary Completion Date :

Oct 9, 2023

Anticipated Study Completion Date :

May 9, 2028

Arms and Interventions

Arm	Intervention/Treatment
PHA SA CO patients having a severe infection treated by injection of phages, with or without surgery	Other: Adverse event after injection of phages rate and description of adverse event after injection of phages
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.	Other: Adverse event after injection of phages rate and description of adverse event after injection of phages

Arm

Intervention/Treatment

PHA SA CO

patients having a severe infection treated by injection of phages, with or without surgery

Other: Adverse event after injection of phages

rate and description of adverse event after injection of phages

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.

Other: Adverse event after injection of phages

rate and description of adverse event after injection of phages

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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