Phage Safety Cohort Study
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: Adverse event after injection of phages.
- Who it may be relevant to
- Registry conditions: Prosthetic Joint Infection, Severe Infection. Basic parameters: from 18 years · 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 →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Other Adverse event after injection of phages
rate and description of adverse event after injection of phages
Primary outcome measures
- type of adverse event [Time frame: 12 months after the injection of phages]
- rate of adverse event [Time frame: 12 months after the injection of phages]
Secondary outcome measures (2)
- biobanking PHA SA CO [Time frame: from before the injection of phages to 6 months after the injection of phages]
- biobanking PhageRESPONSE [Time frame: from before the injection of phages to 6 months after the injection of phages]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hospices Civils de Lyon — Lyon
Identifiers
NCT: NCT04650607 · 30032022