Observing the safety of phage therapy for serious infections
Official title: Phage Safety Cohort Study
Run by Hospices Civils de Lyon · NCT04650607 · Data updated 2026-11-12
This study is testing the safety of using phage therapy to treat serious infections, especially in people with prosthetic joints, by looking at any side effects that might happen.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Status | Recruiting |
| Started | May 9, 2022 |
| Main results expected | October 9, 2023 |
| Study ends | May 9, 2028 |
| Registry record updated | April 13, 2023 |
| Trial ID | NCT04650607 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with serious infections being treated with phage therapy at the CRIOAc Lyon.
✕Probably not a fit
Patients who are under guardianship, deprived of liberty, or pregnant/breastfeeding will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This cohort study aims to document adverse events associated with the use of bacteriophages in treating serious infections, particularly prosthetic joint infections. It will collect data on potential serious adverse events from compassionate cases and classify them based on their relation to surgery, antibiotics, or phage therapy. Additionally, blood specimens will be biobanked before and after treatment to investigate any immunological responses related to phage therapy.
Why it matters
Potential benefit: If successful, this study could provide critical safety data that may support the use of phage therapy as a viable treatment option for serious infections.
How similar studies have gone: While there is limited literature on the safety of phage therapy, this study represents a novel approach to understanding its adverse effects.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hospices Civils de Lyon
Lyon, France Recruiting
Study contacts
- Study coordinator: Johanna Boulant, CRA
- Email: johanna.boulant@chu-lyon.fr
- Phone: 04 26 73 29 38
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.