Phage Safety Cohort Study

Prosthetic Joint Infection Clinical Trial

— PHA-SA-CO  

Official title:

Phage Safety Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04650607
• Other study ID #: 30032022
• Status: Recruiting
• Start date: May 9, 2022
• Est. completion date: May 9, 2028

Study information

• Verified date: May 2022
• Source: Hospices Civils de Lyon
• Contact: Johanna Boulant, CRA
• Phone: 04 26 73 29 38
• Email: johanna.boulant[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 9, 2028
• Est. primary completion date: October 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Prosthetic Joint Infection
• Severe Infection

Intervention

Other:
• Adverse event after injection of phages
rate and description of adverse event after injection of phages

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	type of adverse event	description of the adverse event	12 months after the injection of phages
Primary	rate of adverse event	proportion of patient having an avderse event after injection of phages	12 months after the injection of phages
Secondary	biobanking PHA SA CO	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
Secondary	biobanking PhageRESPONSE	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

External Links

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