NCT05883995

Brief Summary

Avis-PHAGEinLYON Clinic study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients referred to the Hospices Civils de Lyon for a medical advice for a phage therapy from 2015 to 2028. The primary objective is to quantify the phage therapy requests received at the Hospices Civils de Lyon. 1500 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
1,500

participants targeted

Target at P75+ for all trials

Timeline
33mo 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Feb 2023Feb 2029

Study Start

First participant enrolled

February 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

5 years

First QC Date

May 22, 2023

Last Update Submit

May 22, 2023

Conditions

Bone Infection

Keywords

bacteriophagemedical advice

Outcome Measures

Primary Outcomes (1)

  • Number of phage therapy requests

    Number of phage therapy requests received at the Hospices Civils de Lyon from 2015 to 2028 per year and per month.

    at inclusion

Interventions

Phage therapy requestsOTHER

Quantification of phage therapy requests received at the Hospices Civils de Lyon from 2015 to 2028

Eligibility Criteria

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

1500 patients with severe infection treated with phagotherapy will be included in the study.

You may qualify if:

  • \- Patient referred to the Hospices Civils de Lyon for a phage therapy request from 01/01/2015 to 01/01/2028.
  • Avis-PHAGEinLYON clinic 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)

Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc) - Hôpital de la Croix-Rousse

Lyon, 69317, France

RECRUITING

Related Publications (1)

  • Ferry T, Bouar ML, Briot T, Roussel-Gaillard T, Perpoint T, Roux S, Ader F, Valour F, Kassai B, Boussaha I, Ndiaye M, Craighero F, Javaux C, Lustig S, Batailler C; PHAGEinLYON Clinic Study Group. Access to phage therapy at Hospices Civils de Lyon in 2022: Implementation of the PHAGEinLYON Clinic programme. Int J Antimicrob Agents. 2024 Dec;64(6):107372. doi: 10.1016/j.ijantimicag.2024.107372. Epub 2024 Nov 2.

    PMID: 39491599DERIVED

Central Study Contacts

Tristan FERRY, MD

CONTACT

0033 4.72.07.11.07Tristan.ferry@chu-lyon.fr

Myrtille LE BOUAR, CRA

CONTACT

+33 (0)4 72 00 63 33myrtille.le-bouar@chu-lyon.fr

Study Design

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

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 1, 2023

Study Start

February 1, 2023

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

FR(1)