drugset / Trial / NCT06406114
Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing
Phase 2
Recruiting
300 enrolled
Massachusetts General Hospital
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedCrossoverQuadruple-blindDiagnostic
Summary
Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.
Timeline
- Start
- 2025-05-05
- Primary completion
- 2028-07-01
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | — | — |
| Subject | Ampicillin | Unknown | 20 mg/ml | Other |
| Subject | Benzylpenicillin | Unknown | — | Other |
| Subject | CEFACLOR ANHYDROUS | Small molecule | — | — |
| Subject | CEPHALEXIN ANHYDROUS | Small molecule | — | — |
| Subject | Cefadroxil | Small molecule | — | — |
| Subject | Cefazolin | Small molecule | 3.3 mg/ml | Other |
| Subject | Cefazolin | Small molecule | 33 mg/ml | Other |
| Subject | Cefazolin | Small molecule | 330 mg/ml | Other |
| Subject | Cefepime | Small molecule | 2 mg/ml | Other |
| Subject | Cefepime | Small molecule | 20 mg/ml | Other |
| Subject | Cefepime | Small molecule | 200 mg/ml | Other |
| Subject | Cefixime | Other / unclassified | — | — |
| Subject | Cefotaxime | Small molecule | — | Other |
| Subject | Cefpodoxime | Small molecule | — | — |
| Subject | Ceftazidime | Small molecule | 1 mg/ml | Other |
| Subject | Ceftazidime | Small molecule | 10 mg/ml | Other |
| Subject | Ceftazidime | Small molecule | 100 mg/ml | Other |
| Subject | Ceftriaxone | Other / unclassified | 1 mg/ml | Other |
| Subject | Ceftriaxone | Other / unclassified | 10 mg/ml | Other |
| Subject | Ceftriaxone | Other / unclassified | 100 mg/ml | Other |
| Subject | Cefuroxime | Small molecule | 1 mg/ml | Other |
| Subject | Cefuroxime | Small molecule | 10 mg/ml | Other |
| Subject | Cefuroxime | Small molecule | 90 mg/ml | Other |
| Subject | PRE-PEN | Unknown | — | Other |
| Subject | cefdinir | Other / unclassified | — | — |