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NCT04724603 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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: -

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
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Enrolling by invitation NCT05247281 - NGS vs Culture Outcomes for Treatment of PJI N/A
Withdrawn NCT05269121 - Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections Phase 1/Phase 2
Recruiting NCT02801253 - Cohort of Prosthetic Joint Infections
Completed NCT03694925 - Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Revision Total Knee Arthroplasty
Completed NCT03721328 - Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation Phase 2
Withdrawn NCT04787250 - Bacteriophage Therapy in Patients With Prosthetic Joint Infections Phase 1/Phase 2
Recruiting NCT03307109 - Quality of Life in Patients Having a Prosthetic Joint Infection
Recruiting NCT04661345 - Identification of Molecular Marker of Coagulase-negative Staphylococci for the Diagnosis of Prosthetic Joint Infections
Recruiting NCT02805803 - Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection. N/A
Completed NCT02413034 - The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures N/A
Recruiting NCT03784807 - New Strategies for Biofilm Related Infections
Completed NCT04662632 - Abbreviated Protocol for Two-Stage Exchange Phase 2
Not yet recruiting NCT04390607 - Leukocyte Esterase Sensor Test
Recruiting NCT04650607 - Phage Safety Cohort Study
Active, not recruiting NCT04946500 - Clindamycin in Prosthetic Joint Infections Caused by Staphylococcus (CISTA)
Recruiting NCT04762706 - Measuring Distress in Prosthetic Joint Infection Using a Standardized Metric: CRUTCH Pathway Pilot. N/A
Withdrawn NCT05269134 - Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI) Phase 2
Not yet recruiting NCT05239312 - Antibiogram and Biofilm Formation of Bacteria Causing Prosthetic Joint Infections Isolated From Assiut University Hospital
Completed NCT04294862 - Tissue Distribution, Pharmacokinetics, Safety, and Tolerability After a Single Dose of TNP-2092 in Participants Undergoing Primary Total Hip or Knee Arthroplasty Phase 1

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