Actively Recruiting
Phage Safety Cohort Study
Led by Hospices Civils de Lyon · Updated on 2023-04-13
100
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are describing the side effects related to using bacteriophages to treat serious infections. This observational cohort study focuses on gathering information about these adverse events, as there is very little data currently available. The study is sponsored by Hospices Civils de Lyon and includes patients with severe infections treated with phage therapy, sometimes alongside surgery. Patients in the study receive phage injections to combat their infections. The study includes an additional biobanking component where blood samples are collected before and after phage treatment. These samples include blood, serum, and immune cells to explore if immune responses to phages contribute to any side effects. Participants provide data on any serious adverse events up to 12 months after phage injection. Blood samples are collected and stored for up to 6 months post-treatment to support immune response studies. The research team monitors and classifies adverse events to understand if they relate to surgery, antibiotics, or phages. Participants remain in the study to help gather detailed safety data over time.
CONDITIONS
Brief Title
Phage Safety Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 having a minimum weight of 46 kg
You will not qualify if you...
- Patients under guardianship or curatorship
- Patients deprived of liberty
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months after the injection of phages
Participants who receive phage therapy for serious infections are observed for adverse events and undergo blood sample collection for biobanking before and after treatment.
Visits for blood collection before treatment and several visits up to 6 months after treatment
Duration - 12 months after the injection of phages
Participants are followed for up to 12 months after phage injection to monitor the type and rate of any adverse events potentially related to treatment.
Periodic visits up to 12 months
Trial Site Locations
Total: 1 location
1
Hospices Civils de Lyon
Lyon, France, 69004
Actively Recruiting
Research Team
J
Johanna Boulant, CRA
T
Tristan Ferry, Md,PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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