PHAGEinLYON Clinic Cohort Study: a Descriptive Study of Severe Infections Treated With Phage Therapy at the HCL.

December 14, 2023 updated by: Hospices Civils de Lyon

Non Interventional Retrospective and Prospective Single Center Descriptive Study of Severe Infections Treated With Phage Therapy at the Hospices Civils de Lyon (PHAGEinLYON Clinic Cohort Study).

PHAGEinLYON Clinic cohort study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients with a severe infection treated with bacteriophage in the Hospices civils de Lyon from 2015 to 2033. The primary objective is to describe the severe infections treated with phagotherapy. 250 patients will be included in the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

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

  • France
      • Lyon, France, 69004
        • Recruiting
        • Department of Infectious and Tropical Diseases of the Croix Rousse Hospital of the Civil Hospitals of Lyon
        • Contact:
        • Principal Investigator:
          • Tristan FERRY, Pr

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

No

Sampling Method

Non-Probability Sample

Study Population

250 patients with severe infection treated with phagotherapy will be included in the study.

Description

Inclusion Criteria:

  • Patient with severe infection treated with bacteriophage in the Hospices Civils de Lyon from 01/01/2015 to 01/01/2033
  • PHAGEinLYON Clinic cohort study information notice provided to the patient

Exclusion Criteria:

  • Opposition of trial participant

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with severe infection.
Patients with severe infection treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033.
Other: Description of severe infection
Description of severe infections treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of each type of severe infection
Time Frame: through study completion (5years)
Rate of each type of severe infection treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033.
through study completion (5years)

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

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, 2023

Primary Completion (Estimated)

February 1, 2033

Study Completion (Estimated)

February 1, 2034

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 29, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_0189

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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