Phage Safety Cohort Study

Recruiting

• Conditions: Prosthetic Joint Infection; Severe Infection
• Interventions: Other: Adverse event after injection of phages

• Registration Number: NCT04650607
• Lead Sponsor: Hospices Civils de Lyon

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.

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 Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-12-02
• Status Verified: 2022-05
• Study Start: 2022-05-09
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13
• Primary Completion: 2023-10-09
• Study Completion: 2028-05-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PHA SA CO	Adverse event after injection of phages	patients having a severe infection treated by injection of phages, with or without surgery
PhageRESPONSE	Adverse event after injection of phages	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.

Primary Outcome Measures

Name	Time	Method
type of adverse event	12 months after the injection of phages	description of the adverse event
rate of adverse event	12 months after the injection of phages	proportion of patient having an avderse event after injection of phages

Secondary Outcome Measures

Name	Time	Method
biobanking PhageRESPONSE	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
biobanking PHA SA CO	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

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France