Joint InfectionProb-ATBNCT06191601
Interest in Probabilistic Antibiotic Therapy With Broad-spectrum Beta-lactams in Orthopedic Surgery
An observational study of Joint Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The management of Joint Infections (JIs) requires a medical-surgical team which includes rheumatologists, infectious disease specialists, orthopedists as well as microbiologists. This collaboration makes it possible to optimize patient care both from a functional point of view and from an infection point of view. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Infection
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2023to Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient (≥18 years old) operated between January 1, 2021 and December 31, 2021
Who may be able to join
- Adult patient (≥18 years old)
- Hospitalized in the ortho-traumatology department
- Operated between January 1, 2021 and December 31, 2021
- Probabilistic antibiotic therapy with cefepime or piperacillin-tazobactam combined with an anti-gram + antibiotic
- Operated for: Change or washing of THA, TKA, PTE, ablation or resumption of osteosynthesis lower limbs and upper limbs and native osteitis
- Absence of written opposition in the medical file of the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes. It is the responsibility of the investigator to verify the absence of opposition in the patient's medical file.
Who cannot join
- Patient having expressed his opposition to the reuse of his data for scientific research purposes.
- Minor patient
- Patient operated for: Amputation, plantar perforating pain, soft tissue infection
- Patient for whom there is documentation leading to targeted probabilistic antibiotic therapy with beta lactams.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Orthopédie - Traumatologie Membre Supérieur - CHU de Strasbourg - France
Strasbourg, 67091
Jean-Yves JENNY, MD, PhD, 33 3 68 76 51 76, Jean-Yves.JENNY@chru-strasbourg.fr
Elodie BERTHET-BONDET, MD, 33 3 68 76 51 76, elodie.berthet-bondet@chru-strasbourg.fr
About this study
The management of Joint Infections (JIs) requires a medical-surgical team which includes rheumatologists, infectious disease specialists, orthopedists as well as microbiologists.
This collaboration makes it possible to optimize patient care both from a functional point of view and from an infection point of view.
Read more
The diagnosis of these infections is based on clinic, imaging and bacteriology (microbiological samples).
Treatment is based on surgical treatment and appropriate antibiotic therapy, which will be charged only after the sample has been taken. For non-complex native septic arthritis, identification of the bacteria is expected before starting antibiotic therapy adapted to the germ.
For patients requiring surgical treatment: patients with complex native joint infections (comorbidities, allergies, etc.) or joint infections on hardware, the identification of the incriminated germ(s) cannot be expected. Probabilistic antibiotic therapy is then started while awaiting the microbiological results. This antibiotic therapy generally lasts 48 hours, while the results of the antibiogram are known. If for (JIs) on native joints recent recommendations were published by the French society of rheumatology in 2020, it is not the same for (JIs) on hardware. As a result, no updated recommendations indicate the probabilistic antibiotic therapy to prescribe immediately post-operatively. Currently, the old recommendations are no longer applied regarding positive grams. Daptomycin is preferred over vancomycin. On the other hand, for gram-negative germs, broad-spectrum beta-lactams are always prescribed. The investigators are questioning the benefit of these prescriptions given the epidemiological context of joint infections and bacterial resistance phenomena.
The investigators hypothesize that osteoarticular infections are mainly due to gram-positive bacteria.
By affirming this hypothesis, investigators could avoid prescriptions for broad-spectrum beta-lactams. This would lead to a reduction in patient exposure to broad-spectrum antibiotics (fewer adverse effects, ecological and economic gain).
- Conditions
- Joint Infection
- Keywords
- Joint Infection, Antibiotic therapy, Bacterial resistance, Osteoarticular
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the relevance of prescriptions for broad-spectrum beta-lactams in the context of immediate probabilistic antibiotic therapy post-operatively for osteoarticular infections.
This study is retrospective analyzing the medical records of the parties
Measured: Files analysed retrospectively from period from January 1, 2021 to December 31, 2021 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start17 Jul 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191601
- Sponsor's protocol ID
- 9022
- Acronym
- Prob-ATB
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest in Probabilistic Antibiotic Therapy With Broad-spectrum Beta-lactams in Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT06191601
- Acronym / sponsor ID
- Prob-ATB / 9022
- Conditions
- Joint Infection
- Keywords
- Joint Infection, Antibiotic therapy, Bacterial resistance, Osteoarticular
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 5 Jan 2024 (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 management of Joint Infections (JIs) requires a medical-surgical team which includes rheumatologists, infectious disease specialists, orthopedists as well as microbiologists.
This collaboration makes it possible to optimize patient care both from a functional point of view and from an infection point of view.
The diagnosis of these infections is based on clinic, imaging and bacteriology (microbiological samples).
Treatment is based on surgical treatment and appropriate antibiotic therapy, which will be charged only after the sample has been taken. For non-complex native septic arthritis, identification of the bacteria is expected before starting antibiotic therapy adapted to the germ.
For patients requiring surgical treatment: patients with complex native joint infections (comorbidities, allergies, etc.) or joint infections on hardware, the identification of the incriminated germ(s) cannot be expected. Probabilistic antibiotic therapy is then started while awaiting the microbiological results. This antibiotic therapy generally lasts 48 hours, while the results of the antibiogram are known. If for (JIs) on native joints recent recommendations were published by the French society of rheumatology in 2020, it is not the same for (JIs) on hardware. As a result, no updated recommendations indicate the probabilistic antibiotic therapy to prescribe immediately post-operatively. Currently, the old recommendations are no longer applied regarding positive grams. Daptomycin is preferred over vancomycin. On the other hand, for gram-negative germs, broad-spectrum beta-lactams are always prescribed. The investigators are questioning the benefit of these prescriptions given the epidemiological context of joint infections and bacterial resistance phenomena.
The investigators hypothesize that osteoarticular infections are mainly due to gram-positive bacteria.
By affirming this hypothesis, investigators could avoid prescriptions for broad-spectrum beta-lactams. This would lead to a reduction in patient exposure to broad-spectrum antibiotics (fewer adverse effects, ecological and economic gain).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient (≥18 years old) operated between January 1, 2021 and December 31, 2021
Key inclusion criteria (6 listed)
- Adult patient (≥18 years old)
- Hospitalized in the ortho-traumatology department
- Operated between January 1, 2021 and December 31, 2021
- Probabilistic antibiotic therapy with cefepime or piperacillin-tazobactam combined with an anti-gram + antibiotic
- Operated for: Change or washing of THA, TKA, PTE, ablation or resumption of osteosynthesis lower limbs and upper limbs and native osteitis
Key exclusion criteria (4 listed)
- Patient having expressed his opposition to the reuse of his data for scientific research purposes.
- Minor patient
- Patient operated for: Amputation, plantar perforating pain, soft tissue infection
- Patient for whom there is documentation leading to targeted probabilistic antibiotic therapy with beta lactams.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective description of the relevance of prescriptions for broad-spectrum beta-lactams in the context of immediate probabilistic antibiotic therapy post-operatively for osteoarticular infections.
Time frame: Files analysed retrospectively from period from January 1, 2021 to December 31, 2021 will be examined
This study is retrospective analyzing the medical records of the parties
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
Related trials for Joint Infection
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
Effects of Paraffin Wax Therapy and Dry Cupping on Pain and Wrist Function in Patients With Rheumatoid Arthritis
Rheumatic Arthritis
Recruiting
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
Prosthetic Joint Infection of Knee
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
RecruitingPhase 2
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
Prosthetic Joint Infection (PJI)
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 Joint Infection, run by University Hospital, Strasbourg, France 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 6 inclusion and 4 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 5 Jan 2024. 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?
Contact Jean-Yves JENNY, MD, PhD (33 3 68 76 51 76, Jean-Yves.JENNY@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective description of the relevance of prescriptions for broad-spectrum beta-lactams in the context of immediate probabilistic antibiotic therapy post-operatively for osteoarticular infections. (time frame: Files analysed retrospectively from period from January 1, 2021 to December 31, 2021 will be examined). 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 5 Jan 2024.