Phage Safety Retrospective Cohort Study (PHASACO-retro)

April 12, 2023 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of patients having had an adverse event
Time Frame: 1 year
number of patients having had an adverse event
1 year
rate of adverse event attributable to the surgery
Time Frame: 1 year
number of patients having had an adverse event because of the surgery
1 year
type of adverse event attributable to the surgery
Time Frame: 1 year
classification according to Clavien's Clasification
1 year
rate of adverse event attributable to the antibiotic treatment
Time Frame: 1 year
number of patients having had an adverse event because of the antibiotic treatment
1 year
rate of adverse event attributable to the phagotherapy
Time Frame: 1 year
number of patients having had an adverse event because of phagotherapy
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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