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Recruiting NCT04724603

Phage Safety Retrospective Cohort Study

— Observational Bone and Joint Infection Prosthetic Joint Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: patients having had avderse event after phagotherapy for bone or joint or implant infection.
Who it may be relevant to
Registry conditions: Bone and Joint Infection, Prosthetic Joint Infection. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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

Primary outcome measures

  • rate of patients having had an adverse event [Time frame: 1 year]
  • rate of adverse event attributable to the surgery [Time frame: 1 year]
  • type of adverse event attributable to the surgery [Time frame: 1 year]
  • rate of adverse event attributable to the antibiotic treatment [Time frame: 1 year]
  • rate of adverse event attributable to the phagotherapy [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hospices Civils de Lyon — Lyon

Identifiers

NCT: NCT04724603 · 334

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗