Phage Safety Cohort Study (PHA-SA-CO)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Prosthetic Joint Infection; Severe Infection

Treatments: Other: Adverse event after injection of phages

Study type: Observational

Funder types: Other

Identifiers

NCT04650607

30032022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

• Patients under guardianship/curatorship
• Patients deprived of liberty
• Pregnant or breastfeeding women

Trial design

100 participants in 2 patient groups

PHA SA CO

Description:

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

Treatment:

Other: Adverse event after injection of phages

PhageRESPONSE

Description:

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.

Treatment:

Other: Adverse event after injection of phages