PHASACO-retro: Phage Safety Retrospective Cohort Study

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04724603

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to determine the imputability of adverse events in patients who have had phage therapy for the treatment of their bone or joint or implant infection, in order to find out whether these adverse effects are related to surgery, antibiotic treatment or bacteriophages.

Condition or Disease	Intervention/Treatment	Phase
Bone and Joint Infection Prosthetic Joint Infection	Other: patients having had avderse event after phagotherapy for bone or joint or implant infection

Study Design

Study Type:

Observational

Anticipated Enrollment :

14 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Phage Safety Retrospective Cohort Study

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
patients having had avderse event after phagotherapy for bone or joint infection	Other: patients having had avderse event after phagotherapy for bone or joint or implant infection to determine the accountability of adverse effects in having had avderse event after phagotherapy for bone or joint or implant infection

Arm

Intervention/Treatment

patients having had avderse event after phagotherapy for bone or joint infection

Other: patients having had avderse event after phagotherapy for bone or joint or implant infection

to determine the accountability of adverse effects in having had avderse event after phagotherapy for bone or joint or implant infection

Outcome Measures

Primary Outcome Measures

rate of patients having had an adverse event [1 year]
number of patients having had an adverse event
rate of adverse event attributable to the surgery [1 year]
number of patients having had an adverse event because of the surgery
type of adverse event attributable to the surgery [1 year]
classification according to Clavien's Clasification
rate of adverse event attributable to the antibiotic treatment [1 year]
number of patients having had an adverse event because of the antibiotic treatment
rate of adverse event attributable to the phagotherapy [1 year]
number of patients having had an adverse event because of phagotherapy