Phage Safety Retrospective Cohort Study

Prosthetic Joint Infection Clinical Trial

— PHASACO-retro  

Official title:

Phage Safety Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724603
• Other study ID #: 334
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: September 1, 2026

Study information

• Verified date: September 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to determine the imputability of adverse events in patients who have had phage therapy for the treatment of their bone or joint or implant infection, in order to find out whether these adverse effects are related to surgery, antibiotic treatment or bacteriophages.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 1, 2026
• Est. primary completion date: August 1, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients having had a bone or joint or implant infection treated by phagotherapy and having had an adverse event

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone and Joint Infection
• Communicable Diseases
• Infections
• Prosthetic Joint Infection

Intervention

Other:
• patients having had avderse event after phagotherapy for bone or joint or implant infection
to determine the accountability of adverse effects in having had avderse event after phagotherapy for bone or joint or implant infection

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	rate of patients having had an adverse event	number of patients having had an adverse event	1 year
Primary	rate of adverse event attributable to the surgery	number of patients having had an adverse event because of the surgery	1 year
Primary	type of adverse event attributable to the surgery	classification according to Clavien's Clasification	1 year
Primary	rate of adverse event attributable to the antibiotic treatment	number of patients having had an adverse event because of the antibiotic treatment	1 year
Primary	rate of adverse event attributable to the phagotherapy	number of patients having had an adverse event because of phagotherapy	1 year

External Links

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