Phage Safety Cohort Study
PHA-SA-CO
1 other identifier
observational
100
1 country
1
Brief Summary
This cohort study aims to describe the adverse events related to the use of bacteriophages to treat serious infections, data from the literature being almost non-existent on this subject.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2022
Longer than P75 for all trials
1 active site
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
First Submitted
Initial submission to the registry
November 25, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedStudy Start
First participant enrolled
May 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2028
ExpectedApril 13, 2023
May 1, 2022
1.4 years
November 25, 2020
April 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
type of adverse event
description of the adverse event
12 months after the injection of phages
rate of adverse event
proportion of patient having an avderse event after injection of phages
12 months after the injection of phages
Secondary Outcomes (2)
biobanking PHA SA CO
from before the injection of phages to 6 months after the injection of phages
biobanking PhageRESPONSE
from before the injection of phages to 6 months after the injection of phages
Study Arms (2)
PHA SA CO
patients having a severe infection treated by injection of phages, with or without surgery
PhageRESPONSE
ancillary study : Establish a biobanking of serums, plasmas and PBMC (Peripheral Blood Mononuclear Cells) of patients who have been treated with phage therapy for a bacterial infection.
Interventions
rate and description of adverse event after injection of phages
Eligibility Criteria
patients having a severe infection treated by injection of phages at the CRIOAC Lyon, Croix-Rousse Hospital
You may qualify if:
- Patient 18 years of age or older with a serious infection treated at CRIOAc Lyon by phage therapy
- Patient who did not object to participating in the study
- Patients ayant un poids minimum de 46kg
You may not qualify if:
- Patients under guardianship/curatorship
- Patients deprived of liberty
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon
Lyon, 69004, France
Related Links
Biospecimen
PBMC, serums, plasmas
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2020
First Posted
December 2, 2020
Study Start
May 9, 2022
Primary Completion
October 9, 2023
Study Completion (Estimated)
May 9, 2028
Last Updated
April 13, 2023
Record last verified: 2022-05