Safer antibiotic choices before knee, hip, or shoulder replacement for people labeled allergic to penicillin or other beta-lactams
Optimization of Perioperative Antibiotic Prophylaxis in Patients Allergic to Beta-lactams in the Orthopedic Surgery and Trauma Departments of the Strasbourg University Hospitals
University Hospital, Strasbourg, France · NCT07342647
This project will see if using the PEN-FAST allergy score at the pre-op anesthesiology visit helps doctors choose the safest antibiotic for adults labeled allergic to beta-lactams who are having knee, hip, or shoulder replacement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France (other) |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT07342647 on ClinicalTrials.gov |
What this trial studies
This observational program uses preoperative anesthesiology consultations and the PEN-FAST scoring system to stratify risk of true penicillin allergy among adults labeled as allergic to beta-lactams. It includes a retrospective cohort of surgeries performed in 2023 and a prospective cohort of qualifying surgeries performed in 2025 at Strasbourg University Hospital. The study documents which antibiotic prophylaxis agents were chosen and whether PEN-FAST risk strata influenced prescribing or delabeling decisions. Data will be used to characterize current practice and the feasibility of applying PEN-FAST to perioperative antibiotic selection in orthopedic implant surgery.
Who should consider this trial
Good fit: Adults (≥18 years) labeled as allergic to beta-lactams who undergo total knee, shoulder, or hip replacement at Strasbourg University Hospital during the specified enrollment windows and require intraoperative antibiotic prophylaxis.
Not a fit: Patients without a beta-lactam allergy label, those undergoing procedures that do not use implants or do not require antibiotic prophylaxis, and individuals with a confirmed severe beta-lactam hypersensitivity are unlikely to benefit from this work.
Why it matters
Potential benefit: If successful, more patients could safely receive first-line beta-lactam prophylaxis, reducing reliance on broader alternatives and potentially lowering infection rates and antimicrobial resistance.
How similar studies have performed: The PEN-FAST score has been externally validated and used in delabeling pathways with good negative predictive value, but applying it specifically to perioperative antibiotic selection for orthopedic implants remains less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient (≥ 18 years old) * Patient operated on at Strasbourg University Hospital between January 1, 2023, and December 31, 2023, for total knee, shoulder, or hip replacement. * Patients who underwent surgery at Strasbourg University Hospital between March 1, 2025, and July 31, 2025, involving surgery requiring intraoperative antibiotic prophylaxis. Exclusion Criteria: * Patients with a surgical indication without the use of implants. * Patients with a surgical indication without antibiotic prophylaxis.
Where this trial is running
Strasbourg
- Service de Pharmacie - Stérilisation - CHU de Strasbourg - France — Strasbourg, France (RECRUITING)
Study contacts
- Study coordinator: Aurélie REITER-SCHATZ, MD
- Email: aurelie.reiter-schatz@chru-strasbourg.fr
- Phone: 33 3 68 76 50 14
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Beta Lactam Adverse Reaction, Antibiotic Prophylaxis, Beta-Lactamines, Orthopedic Surgery