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Antibiotic therapy in maxillofacial surgery in cases of documented penicillin allergy: a prospective multicenter study of a PEN-FAST-based delabeling and treatment concept with retrospective comparison group

Antibiotic therapy in maxillofacial surgery in cases of documented penicillin allergy: a prospective multicenter study of a PEN-FAST-based delabeling and treatment concept with retrospective comparison group

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038570
Enrollment
80
Registered
2025-11-28
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with odontogenic infection and a history of penicillin allergy

Interventions

Group 1: Prospective implementation of a risk-adapted PEN-FAST-based therapy and delabeling workflow for inpatients undergoing maxillofacial surgery with a documented history of penicillin allergy. If
only evaluation of clinical courses and outcomes (length of stay, revisions, complications, therapy changes).

Sponsors

Bundeswehrzentralkrankenhaus Koblenz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Capable of giving consent, documented history of penicillin allergy (without proven/confirmed allergy), inpatient admission for surgical treatment of odontogenic infections

Exclusion criteria

Exclusion criteria: Unable to give consent, pregnancy or breastfeeding, severe immunosuppression, patients with confirmed penicillin allergy (e.g. diagnosed by an allergist)

Design outcomes

Primary

MeasureTime frame
Proportion of patients with documented penicillin allergy in whom the PEN-FAST-based treatment algorithm prevented clindamycin being prescribed during their hospital stay.

Secondary

MeasureTime frame
Process-related endpoints: • Proportion of patients who underwent oral provocation testing • Proportion with successful delabelling Outcome-related endpoints: • Length of hospital stay • CRP and leukocyte differential (48 hours after initiation of therapy) • Number of surgical revisions • Readmission rate within 30 days • Treatment failure rate (progression, necessary change of antibiotic therapy) • Occurrence of treatment-related complications (sepsis; spread of infection, e.g. mediastinal, cerebral; tracheotomy; intensive care required; death)

Countries

Germany

Contacts

Public ContactAndrea Schmid

Bundeswehrzentralkrankenhaus Koblenz

Andrea2Schmid@bundeswehr.org+4926128127870

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026