Prosthetic Joint InfectionPHA-SA-CONCT04650607
Phage Safety Cohort Study
An observational study of Prosthetic Joint Infection and Severe Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection, Severe Infection
- What is being tested?
- Adverse event after injection of phages
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2022to 9 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients having a severe infection treated by injection of phages at the CRIOAC Lyon, Croix-Rousse Hospital
Who may be able to join
- 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
Who cannot join
- Patients under guardianship/curatorship
- Patients deprived of liberty
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Eugenie Mabrut, CRA, 04 26 73 29 38, eugenie.mabrut@chu-lyon.fr
About this study
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.
Read the detailed description
All potential serious adverse events in compassionate cases will be collected, and classified as potentially related to surgery, to antibiotics, or to phages, with the help of the HCL pharmacovigilance center. In addition, biobanking of pre- and post-treatment blood specimens (bloods, serums and cells) will determine whether phage immunization is implicated in particular adverse events.
- Conditions
- Prosthetic Joint Infection, Severe Infection
- Being tested
- Adverse event after injection of phages
- Keywords
- phage, adverse event, severe infection, compassionate treatment
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adverse event after injection of phagesOther
rate and description of adverse event after injection of phages
| Study group | Role | What they receive |
|---|---|---|
| PHA SA CO | patients having a severe infection treated by injection of phages, with or without surgery Receives: Other: Adverse event after injection of phages | |
| PhageRESPONSE | ancillary study : Establish a biobanking of serums, plasmas and PBMC (Peripheral Blood Mononuclear Cells) of patients who have been treated with phage therapy for a bacterial infection. Receives: Other: Adverse event after injection of phages |
What is being measured
The primary outcome is the main question the study is designed to answer.
type of adverse event
description of the adverse event
Measured: 12 months after the injection of phages
rate of adverse event
proportion of patient having an avderse event after injection of phages
Measured: 12 months after the injection of phages
Secondary outcomes (2)
biobanking PHA SA CO
to assess the role of immunization induced by phage phages in the occurrence of adverse
Measured: from before the injection of phages to 6 months after the injection of phages
biobanking PhageRESPONSE
Characterize the cellular and humoral immune response in patients with a severe bacterial infection requiring treatment compassionate by bacteriophage
Measured: from before the injection of phages to 6 months after the injection of phages
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start9 May 2022
- Primary completion9 Oct 2023 (estimated)
- Study completion9 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic 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
- Prospective
- Enrolment
- 100 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
- NCT04650607
- Sponsor's protocol ID
- 30032022
- Acronym
- PHA-SA-CO
- Status last verified
- May 2022
- First submitted
- 25 Nov 2020
- 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 Cohort Study
- ClinicalTrials.gov ID
- NCT04650607
- Acronym / sponsor ID
- PHA-SA-CO / 30032022
- Conditions
- Prosthetic Joint Infection, Severe Infection
- Keywords
- phage, adverse event, severe infection, compassionate treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 9 Oct 2023 (estimated)
- Study completion
- 9 May 2028 (estimated)
- First posted
- 2 Dec 2020 (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.
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.
Detailed description
All potential serious adverse events in compassionate cases will be collected, and classified as potentially related to surgery, to antibiotics, or to phages, with the help of the HCL pharmacovigilance center. In addition, biobanking of pre- and post-treatment blood specimens (bloods, serums and cells) will determine whether phage immunization is implicated in particular adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHA SA CO | – | Other: Adverse event after injection of phagespatients having a severe infection treated by injection of phages, with or without surgery |
| PhageRESPONSE | – | Other: Adverse event after injection of phagesancillary study : Establish a biobanking of serums, plasmas and PBMC (Peripheral Blood Mononuclear Cells) of patients who have been treated with phage therapy for a bacterial infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients having a severe infection treated by injection of phages at the CRIOAC Lyon, Croix-Rousse Hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients under guardianship/curatorship
- Patients deprived of liberty
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Adverse event after injection of phagesrate and description of adverse event after injection of phages | Other | PHA SA CO, PhageRESPONSE |
Primary outcome
type of adverse event
Time frame: 12 months after the injection of phages
description of the adverse event
rate of adverse event
Time frame: 12 months after the injection of phages
proportion of patient having an avderse event after injection of phages
2 secondary outcomes
biobanking PHA SA CO
Time frame: from before the injection of phages to 6 months after the injection of phages
biobanking PhageRESPONSE
Time frame: from before the injection of phages to 6 months after the injection of phages
Results and safety
This study is still under way. Results are not available in the source record yet.
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.
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 Prosthetic Joint Infection and Severe 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 3 inclusion and 3 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanna Boulant, CRA (04 26 73 29 38, johanna.boulant@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
type of adverse event (time frame: 12 months after the injection of phages). The study lists 2 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.