Clinical Trials Logo
  1. Home
  2. Prosthetic Joint Infection
  3. NCT04650607
  4. Details
NCT04650607 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT04067843 - Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study N/A
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
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
Recruiting NCT05060952 - Calprotectin in Chronic Prosthetic Joint Infection

External Links