Severe InfectionNCT06185920
PHAGEinLYON Clinic Cohort Study: a Descriptive Study of Severe Infections Treated With Phage Therapy at the HCL.
An observational study of Severe Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
PHAGEinLYON Clinic cohort study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients with a severe infection treated with bacteriophage in the Hospices civils de Lyon from 2015 to 2033. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Infection
- What is being tested?
- Description of severe infection
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 1 Feb 2034
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 250 patients with severe infection treated with phagotherapy will be included in the study.
Who may be able to join
- Patient with severe infection treated with bacteriophage in the Hospices Civils de Lyon from 01/01/2015 to 01/01/2033
- PHAGEinLYON Clinic cohort study information notice provided to the patient
Who cannot join
- Opposition of trial participant
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
Department of Infectious and Tropical Diseases of the Croix Rousse Hospital of the Civil Hospitals of Lyon
Lyon, 69004
Tristan FERRY, Pr, 04 72 07 24 81 ext. +33, tristan.ferry@chu-lyon.fr
Tristan FERRY, Pr
About this study
Official title: Non Interventional Retrospective and Prospective Single Center Descriptive Study of Severe Infections Treated With Phage Therapy at the Hospices Civils de Lyon (PHAGEinLYON Clinic Cohort Study).
PHAGEinLYON Clinic cohort study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients with a severe infection treated with bacteriophage in the Hospices civils de Lyon from 2015 to 2033. The primary objective is to describe the severe infections treated with phagotherapy. 250 patients will be included in the study.
- Conditions
- Severe Infection
- Being tested
- Description of severe infection
- Keywords
- bacteriophage, severe infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description of severe infectionOther
Description of severe infections treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe infection. | Patients with severe infection treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033. Receives: Other: Description of severe infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of each type of severe infection
Rate of each type of severe infection treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033.
Measured: through study completion (5years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2033 (estimated)
- Study completion1 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Cross-sectional
- Enrolment
- 250 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
- NCT06185920
- Sponsor's protocol ID
- 69HCL23_0189
- Status last verified
- Dec 2023
- First submitted
- 27 Oct 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional Retrospective and Prospective Single Center Descriptive Study of Severe Infections Treated With Phage Therapy at the Hospices Civils de Lyon (PHAGEinLYON Clinic Cohort Study).
- ClinicalTrials.gov ID
- NCT06185920
- Acronym / sponsor ID
- 69HCL23_0189
- Conditions
- Severe Infection
- Keywords
- bacteriophage, severe infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2033 (estimated)
- Study completion
- 1 Feb 2034 (estimated)
- First posted
- 29 Dec 2023 (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.
PHAGEinLYON Clinic cohort study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients with a severe infection treated with bacteriophage in the Hospices civils de Lyon from 2015 to 2033. The primary objective is to describe the severe infections treated with phagotherapy. 250 patients will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe infection. | – | Other: Description of severe infectionPatients with severe infection treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 250 patients with severe infection treated with phagotherapy will be included in the study.
Key inclusion criteria (2 listed)
- Patient with severe infection treated with bacteriophage in the Hospices Civils de Lyon from 01/01/2015 to 01/01/2033
- PHAGEinLYON Clinic cohort study information notice provided to the patient
Key exclusion criteria (1 listed)
- Opposition of trial participant
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 |
|---|---|---|
| Description of severe infectionDescription of severe infections treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033. | Other | Patients with severe infection. |
Primary outcome
Rate of each type of severe infection
Time frame: through study completion (5years)
Rate of each type of severe infection treated with bacteriophage in the Hospices Civils de Lyon from 2015 to 2033.
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 29 Dec 2023.
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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.
Department of Infectious and Tropical Diseases of the Croix Rousse Hospital of the Civil Hospitals of Lyon
Lyon, France
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 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 2 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: looking for participants now, as of the sponsor's last update on 29 Dec 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?
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 each type of severe infection (time frame: through study completion (5years)). 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 29 Dec 2023.