NCT04650607

Phage Safety Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prosthetic Joint Infection
• Severe Infection

Interventions

Type	Name	Description
OTHER	Adverse event after injection of phages	rate and description of adverse event after injection of phages

Timeline

• Start date: 2022-05-09
• Primary completion: 2023-10-09
• Completion: 2028-05-09
• First posted: 2020-12-02
• Last updated: 2023-04-13

Locations

1 site across 1 country: France