NCT06067919: PROPHYLAL

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

Completed NA Last updated 24 August 2025

What this trial tests

NA trial testing decision tree for the choice of intraoperative antibiotic prophylaxis in Adult Patients Who Declare an Allergy to Penicillin During Anaesthetic Consultation Without Any Allergy Work up That Could Confirm This Declaration in 275 participants. Completed in 20 May 2025.

Timeline

9 October 2023

Primary endpoint
30 December 2024

20 May 2025

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	275
Start date	9 October 2023
Primary completion	30 December 2024
Estimated completion	20 May 2025
Sites	1 location across France

Drugs / interventions tested

• decision tree for the choice of intraoperative antibiotic prophylaxis

Conditions studied

• Adult Patients Who Declare an Allergy to Penicillin During Anaesthetic Consultation Without Any Allergy Work up That Could Confirm This Declaration — all drugs for Adult Patients Who Declare an Allergy to Penicillin During Anaesthetic Consultation Without Any Allergy Work up That Could Confirm This Declaration →
• Good Comprehension of French Language — all drugs for Good Comprehension of French Language →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Adult Patients Who Declare an Allergy to Penicillin During Anaesthetic Consultation Without Any Allergy Work up That Could Confirm This Declaration or Good Comprehension of French Language. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

According to the Centers for Disease Control and Prevention (CDC), a surgical site infection (SSI) is an infection that occurs after surgery at the site where the surgery was performed. The prevalence of SSIs is difficult to obtain and is probably underestimated, as many SSIs occur after the patient has been discharged from hospital and are not taken into account. SSIs are responsible for an increase in length of stay, mortality and costs. Their prevention is therefore essential in the operating theater, and has been the subject of recommendations recently updated by the CDC. The first line of prevention is the administration of prophylaxis antibiotic adapted to the surgical procedure, administered within a specific timeframe in order to achieve an effective bactericidal concentration in the tissues at the time of the surgical incision. In France, in the United States and for the WHO, the recommended first line of antibiotic prophylaxis is most often an agent from the beta-lactam family, a penicillin or a cephalosporin, with the exception of ophthalmological surgery. No strategy is described for the management of patients with a reported allergy to penicillin, apart from the recommendation of therapeutic alternatives.

The use of a decision-making strategy in the operating theater for patients with a reported allergy to penicillin therefore appears necessary and is recommended by experts. In the intraoperative context, the application of a strategy would make it possible to guide the use of cephalosporins, without removing the "penicillin allergy" label from the patient, but by proposing an alternative via the use of a cephalosporin depending on the probability of the risk of a real allergy to penicillin, according to the description of the former reaction.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. National expert consensus on the management of antibiotic prophylaxis in surgical patients with a penicillin allergy label based on the Delphi method.
   Gouel-Chéron A, Neukirch C, Barbaud A, Dupont A, et al · · 2025 · PMID 40046066 · DOI 10.1093/jacamr/dlaf024