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

NCT06191601 | Unknown

• 1 other identifier: 9022
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Joint Infection

Keywords

Joint Infection; Antibiotic therapy; Bacterial resistance; Osteoarticular

Outcome Measures

Primary Outcomes (1)

• 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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient (≥18 years old) operated between January 1, 2021 and December 31, 2021

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service d'Orthopédie - Traumatologie Membre Supérieur - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Central Study Contacts

Jean-Yves JENNY, MD, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: July 17, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-12

Locations

FR (1)