UnknownNot Applicable

Interest in Probabilistic Antibiotic Therapy With Broad-spectrum Beta-lactams in Orthopedic Surgery

France150 participantsStarted 2023-07-17

Plain-language 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. 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: Files analysed retrospectively from period from January 1, 2021 to December 31, 2021 will be examined

Trial details

NCT IDNCT06191601

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07

Contact for this trial

Jean-Yves JENNY, MD, PhD

33 3 68 76 51 76 Jean-Yves.JENNY@chru-strasbourg.fr

View on ClinicalTrials.gov More Joint Infection trials