NCT04724603

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Feb 2021Sep 2026

First Submitted

Initial submission to the registry

January 22, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

April 13, 2023

Status Verified

September 1, 2022

Enrollment Period

1.5 years

First QC Date

January 22, 2021

Last Update Submit

April 12, 2023

Conditions

Bone and Joint InfectionProsthetic Joint Infection

Keywords

bone and joint infectionphagotherapyadverse eventProsthetic Joint Infection

Outcome Measures

Primary Outcomes (5)

  • rate of patients having had an adverse event

    number of patients having had an adverse event

    1 year

  • rate of adverse event attributable to the surgery

    number of patients having had an adverse event because of the surgery

    1 year

  • type of adverse event attributable to the surgery

    classification according to Clavien's Clasification

    1 year

  • rate of adverse event attributable to the antibiotic treatment

    number of patients having had an adverse event because of the antibiotic treatment

    1 year

  • rate of adverse event attributable to the phagotherapy

    number of patients having had an adverse event because of phagotherapy

    1 year

Study Arms (1)

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

Interventions

patients having had avderse event after phagotherapy for bone or joint or implant infectionOTHER

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

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

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having had a bone or joint or implant infection treated by phagotherapy at the CRIOAc Lyon and having had an adverse event

You may qualify if:

  • patients having had a bone or joint or implant infection treated by phagotherapy and having had an adverse event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

RECRUITING

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2021

First Posted

January 26, 2021

Study Start

February 1, 2021

Primary Completion

August 1, 2022

Study Completion (Estimated)

September 1, 2026

Last Updated

April 13, 2023

Record last verified: 2022-09

Locations

FR(1)