Observing the safety of phage therapy for serious infections
Phage Safety Cohort Study
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT04650607 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with serious infections being treated with phage therapy at the CRIOAc Lyon.
Not a fit: Patients who are under guardianship, deprived of liberty, or pregnant/breastfeeding will not benefit from this study.
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 performed: While there is limited literature on the safety of phage therapy, this study represents a novel approach to understanding its adverse effects.
Eligibility criteria
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 this trial is running
Lyon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.