Phage Safety Cohort Study

NCT ID: NCT04650607

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-09

Study Completion Date

2028-05-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prosthetic Joint Infection Severe Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PHA SA CO

patients having a severe infection treated by injection of phages, with or without surgery

Adverse event after injection of phages

Intervention Type OTHER

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.

Adverse event after injection of phages

Intervention Type OTHER

rate and description of adverse event after injection of phages

Interventions

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Adverse event after injection of phages

rate and description of adverse event after injection of phages

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Johanna Boulant, CRA

Role: CONTACT

04 26 73 29 38

Tristan Ferry, Md,PhD

Role: CONTACT

04 26 73 29 38

Facility Contacts

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Eugenie Mabrut, CRA

Role: primary

04 26 73 29 38

Related Links

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Other Identifiers

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30032022

Identifier Type: -

Identifier Source: org_study_id

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