Phage Safety Retrospective Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHospices Civils de Lyon
About this trial
The aim of this study is to determine the imputability of adverse events in patients who have had phage therapy for the treatment of their bone or joint or implant infection, in order to find out whether these adverse effects are related to surgery, antibiotic treatment or bacteriophages.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients having had a bone or joint or implant infection treated by phagotherapy and having had an adverse event
Disqualifiers
None
Trial population
patients having had a bone or joint or implant infection treated by phagotherapy at the CRIOAc Lyon and having had an adverse event
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
patients having had avderse event after phagotherapy for bone or joint or implant infection
Other interventionto determine the accountability of adverse effects in having had avderse event after phagotherapy for bone or joint or implant infection
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: patients having had avderse event after phagotherapy for bone or joint infection1 intervention
Trial outcomes
Primary outcomes
1
rate of patients having had an adverse event
number of patients having had an adverse event
Time frame
1 year2
rate of adverse event attributable to the surgery
number of patients having had an adverse event because of the surgery
Time frame
1 year3
type of adverse event attributable to the surgery
classification according to Clavien's Clasification
Time frame
1 year4
rate of adverse event attributable to the antibiotic treatment
number of patients having had an adverse event because of the antibiotic treatment
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov