Bone and Joint InfectionPHASACO-retroNCT04724603
Phage Safety Retrospective Cohort Study
An observational study of Bone and Joint Infection and Prosthetic Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone and Joint Infection, Prosthetic Joint Infection
- What is being tested?
- patients having had avderse event after phagotherapy for bone or joint or implant infection
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: patients having had a bone or joint or implant infection treated by phagotherapy at the CRIOAc Lyon and having had an adverse event
Who may be able to join
- patients having had a bone or joint or implant infection treated by phagotherapy and having had an adverse event
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Johanna Boulant, CRA, 04 26 73 29 38, johanna.boulant@chu-lyon.fr
About this study
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.
- Being tested
- patients having had avderse event after phagotherapy for bone or joint or implant infection
- Keywords
- bone and joint infection, phagotherapy, adverse event, Prosthetic Joint Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients having had avderse event after phagotherapy for bone or joint or implant infectionOther
to determine the accountability of adverse effects in having had avderse event after phagotherapy for bone or joint or implant infection
| Study group | Role | What they receive |
|---|---|---|
| patients having had avderse event after phagotherapy for bone or joint infection | Not described Receives: Other: patients having had avderse event after phagotherapy for bone or joint or implant infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patients having had an adverse event
number of patients having had an adverse event
Measured: 1 year
rate of adverse event attributable to the surgery
number of patients having had an adverse event because of the surgery
Measured: 1 year
type of adverse event attributable to the surgery
classification according to Clavien's Clasification
Measured: 1 year
rate of adverse event attributable to the antibiotic treatment
number of patients having had an adverse event because of the antibiotic treatment
Measured: 1 year
rate of adverse event attributable to the phagotherapy
number of patients having had an adverse event because of phagotherapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Feb 2021
- Primary completion1 Aug 2022
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724603
- Sponsor's protocol ID
- 334
- Acronym
- PHASACO-retro
- Status last verified
- Sep 2022
- First submitted
- 22 Jan 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phage Safety Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04724603
- Acronym / sponsor ID
- PHASACO-retro / 334
- Keywords
- bone and joint infection, phagotherapy, adverse event, Prosthetic Joint Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients having had avderse event after phagotherapy for bone or joint infection | – | Other: patients having had avderse event after phagotherapy for bone or joint or implant infection |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients having had a bone or joint or implant infection treated by phagotherapy at the CRIOAc Lyon and having had an adverse event
Key inclusion criteria (1 listed)
- patients having had a bone or joint or implant infection treated by phagotherapy and having had an adverse event
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients having had avderse event after phagotherapy for bone or joint or implant infectionto determine the accountability of adverse effects in having had avderse event after phagotherapy for bone or joint or implant infection | Other | patients having had avderse event after phagotherapy for bone or joint infection |
Primary outcome
rate of patients having had an adverse event
Time frame: 1 year
number of patients having had an adverse event
rate of adverse event attributable to the surgery
Time frame: 1 year
number of patients having had an adverse event because of the surgery
type of adverse event attributable to the surgery
Time frame: 1 year
classification according to Clavien's Clasification
rate of adverse event attributable to the antibiotic treatment
Time frame: 1 year
number of patients having had an adverse event because of the antibiotic treatment
rate of adverse event attributable to the phagotherapy
Time frame: 1 year
number of patients having had an adverse event because of phagotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone and Joint Infection and Prosthetic Joint Infection, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of patients having had an adverse event (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.