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NCT Number: NCT04724603

Phage Safety Retrospective Cohort Study

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.

Recruiting

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Key information

Conditions

Bone and Joint Infection Prosthetic Joint Infection

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

patients having had avderse event after phagotherapy for bone or joint or implant infection

Other

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

Primary outcomes

  1. rate of patients having had an adverse event

    Time frame: 1 year

    number of patients having had an adverse event

  2. rate of adverse event attributable to the surgery

    Time frame: 1 year

    number of patients having had an adverse event because of the surgery

  3. type of adverse event attributable to the surgery

    Time frame: 1 year

    classification according to Clavien's Clasification

  4. rate of adverse event attributable to the antibiotic treatment

    Time frame: 1 year

    number of patients having had an adverse event because of the antibiotic treatment

  5. rate of adverse event attributable to the phagotherapy

    Time frame: 1 year

    number of patients having had an adverse event because of phagotherapy

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PHASACO-retro

Important dates

Study start
2021
Primary completion
2022
Study completion
2026
First posted
Jan 26, 2021
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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