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Phage Safety Cohort Study (PHA-SA-CO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04650607
Recruitment Status : Not yet recruiting
First Posted : December 2, 2020
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:
The aim of this cohort is to enhance knowledge of phage safety, whatever the purified phage used in the next six years. Declaration of adverse reactions is required by EU data protection rules, especially for off-label drugs.

Condition or disease Intervention/treatment
Prosthetic Joint Infection Bone and Joint Infection Implant Infection Other: Adverse event after injection of phages

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 (serum and cells) will determine whether phage immunization is implicated in particular adverse events. This observational cohort study will be initiated during year 1, in compliance with all French health authority rules
Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phage Safety Cohort Study
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Adverse event after injection of phages
patients having a BJI/PJI 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


Outcome Measures
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Primary Outcome Measures :
  1. rate of adverse event [ Time Frame: 12 months after the injection of phages ]
    proportion of patient having an avderse event after injection of phages

  2. type of adverse event [ Time Frame: 12 months after the injection of phages ]
    description of the adverse event


Secondary Outcome Measures :
  1. biobanking [ Time Frame: from before the injection of phages to 3 months after the surgery with injection of phages ]
    to assess the role of immunization induced by phage phages in the occurrence of adverse


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients having a BJI/PJI treated by injection of phages at the time of the surgery managed at the CRIOAC Lyon, Croix-Rousse Hospital
Criteria

Inclusion Criteria:

  • patients having a BJI/PJI treated by injection of phages at the time of the surgery

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04650607


Contacts
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Contact: Eugenie Mabrut, CRA 04 26 73 29 38 eugenie.mabrut@chu-lyon.fr
Contact: Tristan Ferry, Md,PhD 04 26 73 29 38 tristan.ferry@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon
Lyon, France, 69004
Contact: Eugenie Mabrut, CRA    04 26 73 29 38    eugenie.mabrut@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Additional Information:

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04650607    
Other Study ID Numbers: en cours 3
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
phage
adverse event
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Arthritis, Infectious
Disease Attributes
 Pathologic Processes
Arthritis
Joint Diseases
Musculoskeletal Diseases