Phage Safety Cohort Study (PHA-SA-CO)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All potential serious adverse events in compassionate cases will be collected, and classified as potentially related to surgery, to antibiotics, or to phages, with the help of the HCL pharmacovigilance center. In addition, biobanking of pre- and post-treatment blood specimens (bloods, serums and cells) will determine whether phage immunization is implicated in particular adverse events.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Lyon, France, 69004
        • Recruiting
        • Hospices Civils de Lyon

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients having a severe infection treated by injection of phages at the CRIOAC Lyon, Croix-Rousse Hospital

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients under guardianship/curatorship
  • Patients deprived of liberty
  • Pregnant or breastfeeding women

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
PHA SA CO
patients having a severe infection treated by injection of phages, with or without surgery
Other: Adverse event after injection of phages
rate and description of adverse event after injection of phages
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.
Other: Adverse event after injection of phages
rate and description of adverse event after injection of phages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
type of adverse event
Time Frame: 12 months after the injection of phages
description of the adverse event
12 months after the injection of phages
rate of adverse event
Time Frame: 12 months after the injection of phages
proportion of patient having an avderse event after injection of phages
12 months after the injection of phages

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biobanking PHA SA CO
Time Frame: from before the injection of phages to 6 months after the injection of phages
to assess the role of immunization induced by phage phages in the occurrence of adverse
from before the injection of phages to 6 months after the injection of phages
biobanking PhageRESPONSE
Time Frame: from before the injection of phages to 6 months after the injection of phages
Characterize the cellular and humoral immune response in patients with a severe bacterial infection requiring treatment compassionate by bacteriophage
from before the injection of phages to 6 months after the injection of phages

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)

May 9, 2022

Primary Completion (Anticipated)

October 9, 2023

Study Completion (Anticipated)

May 9, 2028

Study Registration Dates

First Submitted

November 25, 2020

First Submitted That Met QC Criteria

November 25, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30032022

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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