Phage Safety Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients under guardianship/curatorship
Patients deprived of liberty
Pregnant or breastfeeding women
Trial population
patients having a severe infection treated by injection of phages at the CRIOAC Lyon, Croix-Rousse Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Adverse event after injection of phages
Other interventionrate and description of adverse event after injection of phages
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PHA SA CO1 intervention
Group B: PhageRESPONSE1 intervention
Trial outcomes
Primary outcomes
1
type of adverse event
description of the adverse event
Time frame
12 months after the injection of phages2
rate of adverse event
proportion of patient having an avderse event after injection of phages
Time frame
12 months after the injection of phagesSecondary outcomes
1
biobanking PHA SA CO
to assess the role of immunization induced by phage phages in the occurrence of adverse
Time frame
from before the injection of phages to 6 months after the injection of phages2
biobanking PhageRESPONSE
Characterize the cellular and humoral immune response in patients with a severe bacterial infection requiring treatment compassionate by bacteriophage
Time frame
from before the injection of phages to 6 months after the injection of phagesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov