Bone InfectionNCT05883995
Avis-PHAGEinLYON Clinic
An observational study of Bone Infection, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Avis-PHAGEinLYON Clinic study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients referred to the Hospices Civils de Lyon for a medical advice for a phage therapy from 2015 to 2028. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Infection
- What is being tested?
- Phage therapy requests
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2023to 1 Feb 2029
- 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: 1500 patients with severe infection treated with phagotherapy will be included in the study.
Who may be able to join
- - Patient referred to the Hospices Civils de Lyon for a phage therapy request from 01/01/2015 to 01/01/2028.
- Avis-PHAGEinLYON clinic 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
Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc) - Hôpital de la Croix-Rousse
Lyon, 69317
Tristan FERRY, MD, PhD, 0472071107 ext. +33, tristan.ferry@chu-lyon.fr
Johanna BOULANT, ARC, 0426732938 ext. +33, johanna.boulant@chu-lyon.fr
About this study
Avis-PHAGEinLYON Clinic study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients referred to the Hospices Civils de Lyon for a medical advice for a phage therapy from 2015 to 2028. The primary objective is to quantify the phage therapy requests received at the Hospices Civils de Lyon. 1500 patients will be included in the study.
- Conditions
- Bone Infection
- Being tested
- Phage therapy requests
- Keywords
- bacteriophage, medical advice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phage therapy requestsOther
Quantification of phage therapy requests received at the Hospices Civils de Lyon from 2015 to 2028
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of phage therapy requests
Number of phage therapy requests received at the Hospices Civils de Lyon from 2015 to 2028 per year and per month.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 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
- NCT05883995
- Sponsor's protocol ID
- 23-5092
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferry T, Bouar ML, Briot T, Roussel-Gaillard T, Perpoint T, Roux S, Ader F, Valour F, Kassai B, Boussaha I, Ndiaye M, Craighero F, Javaux C, Lustig S, Batailler C; PHAGEinLYON Clinic Study Group. Access to phage therapy at Hospices Civils de Lyon in 2022: Implementation of the PHAGEinLYON Clinic programme. Int J Antimicrob Agents. 2024 Dec;64(6):107372. doi: 10.1016/j.ijantimicag.2024.107372. Epub 2024 Nov 2.
PubMed 39491599
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avis-PHAGEinLYON Clinic
- ClinicalTrials.gov ID
- NCT05883995
- Acronym / sponsor ID
- 23-5092
- Conditions
- Bone Infection
- Keywords
- bacteriophage, medical advice
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 1 Jun 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.
Avis-PHAGEinLYON Clinic study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients referred to the Hospices Civils de Lyon for a medical advice for a phage therapy from 2015 to 2028. The primary objective is to quantify the phage therapy requests received at the Hospices Civils de Lyon. 1500 patients will be included in the study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1500 patients with severe infection treated with phagotherapy will be included in the study.
Key inclusion criteria (2 listed)
- - Patient referred to the Hospices Civils de Lyon for a phage therapy request from 01/01/2015 to 01/01/2028.
- Avis-PHAGEinLYON clinic 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 |
|---|---|---|
| Phage therapy requestsQuantification of phage therapy requests received at the Hospices Civils de Lyon from 2015 to 2028 | Other | – |
Primary outcome
Number of phage therapy requests
Time frame: at inclusion
Number of phage therapy requests received at the Hospices Civils de Lyon from 2015 to 2028 per year and per month.
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 1 Jun 2023.
- Derived from this study: PubMed 39491599Ferry T, Bouar ML, Briot T, Roussel-Gaillard T, Perpoint T, Roux S, Ader F, Valour F, Kassai B, Boussaha I, Ndiaye M, Craighero F, Javaux C, Lustig S, Batailler C; PHAGEinLYON Clinic Study Group. Access to phage therapy at Hospices Civils de Lyon in 2022: Implementation of the PHAGEinLYON Clinic programme. Int J Antimicrob Agents. 2024 Dec;64(6):107372. doi: 10.1016/j.ijantimicag.2024.107372. Epub 2024 Nov 2.
Related trials for Bone Infection
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Hematologic Malignancy, Leukemia
RecruitingObservational study
Natural History Study of GATA2 Deficiency and Related Disorders
GATA2 Deficiency
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
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 Bone 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 1 Jun 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 Tristan FERRY, MD (0033 4.72.07.11.07, Tristan.ferry@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of phage therapy requests (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883995, which also lists 1 linked publication.
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 1 Jun 2023.