NCT06185920

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
94mo left

Started Feb 2023

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

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Study Timeline

Key milestones and dates

Study Progress30%
Feb 2023Feb 2034

Study Start

First participant enrolled

February 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2033

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2034

Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

10 years

First QC Date

October 27, 2023

Last Update Submit

December 14, 2023

Conditions

Severe Infection

Keywords

bacteriophagesevere infection

Outcome Measures

Primary Outcomes (1)

  • Rate of each type of severe infection

    Rate of each type of severe infection treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033.

    through study completion (5years)

Study Arms (1)

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

Interventions

Description of severe infectionOTHER

Description of severe infections treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033.

Patients with severe infection.

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

  • Opposition of trial participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious and Tropical Diseases of the Croix Rousse Hospital of the Civil Hospitals of Lyon

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Infections

Study Design

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

Study Record Dates

First Submitted

October 27, 2023

First Posted

December 29, 2023

Study Start

February 1, 2023

Primary Completion (Estimated)

February 1, 2033

Study Completion (Estimated)

February 1, 2034

Last Updated

December 29, 2023

Record last verified: 2023-12

Locations

FR(1)