Guiding antibiotic choices for patients allergic to penicillin during surgery
Assessment of the Applicability and Acceptability of an Algorithm to Guide the Prescription of 1st and 2nd Generation Cephalosporins as Part of Intraoperative Antibiotic Prophylaxis in Patients With a Declared Allergy to Penicillin
This study tests a new way to choose safe antibiotics for adults with a penicillin allergy who need surgery to see if it helps prevent infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06067919 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates an algorithm designed to assist in selecting appropriate first and second generation cephalosporins for antibiotic prophylaxis in patients who report an allergy to penicillin. The study focuses on adult patients who have not undergone allergy testing and require antibiotic prophylaxis for surgery. By implementing a decision-making strategy in the operating room, the trial aims to improve the management of antibiotic administration and reduce the risk of surgical site infections. The study will be conducted at Bichat hospital in Paris, targeting patients who understand French.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who declare an allergy to penicillin and have a good understanding of the French language.
Not a fit: Patients who are allergic to antibiotics other than penicillin or those requiring different first-line antibiotics will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the safety and effectiveness of antibiotic prophylaxis in patients with penicillin allergies, potentially reducing surgical site infections.
How similar studies have performed: While the specific algorithm is novel, similar approaches in managing antibiotic prophylaxis for allergic patients have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18 years; * Patients with a good French understanding * Who declare themselves allergic to penicillin and who have not benefit from an allergy work-up to explore their allergies and possible therapeutic alternatives; * Requiring antibiotic prophylaxis with either first or second generation cephalosporins for elective or emergency surgery. Exclusion Criteria: * Refusal to sign informed consent * Patient under legal protection ; * Pregnant women; * Patient scheduled for surgery requiring first-line antibiotic prophylaxis with an agent other than first and second generation cephalosporins (such as amoxicillin/clavulanate or vancomycin) according to the recommendations of the French Society of Anaesthesia and Intensive Care (SFAR) in one of the investigating centres; * Patient declaring an allergy to antibiotics other than penicillins. * Not affiliated to a social security scheme
Where this trial is running
Paris
- Bichat hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: Mouna Ben Rehouma — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Aurelie Gouel Cheron
- Email: aurelie.gouel@aphp.fr
- Phone: 140258355
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.