Clinical Trials
Several clinical trials sponsored by academic and healthcare institutions—including the University of Michigan, McGill University Health Centre, Fondation Hôpital Saint-Joseph, and University Hospital Tours—evaluate cefazolin across diverse clinical settings. These studies examine conditions such as surgical prophylaxis, hemodialysis catheter infections, prosthetic joint infections, and adverse beta-lactam allergic reactions. Currently recruiting or active not recruiting, the trials encompass Phase 4 evaluations alongside non-phase observational and pharmacokinetic protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06093269 | Recruiting | Hemodialysis Catheter Infection|Infection Bacterial |
University Hospital Tours |
2023-11-20 | Phase 4 |
| NCT06005168 | Recruiting | Surgical Prophylaxis |
University of Michigan|Agency for Healthcare Research and Quality (AHRQ) |
2023-03-08 | Phase 4 |
| NCT05605795 | Active not recruiting | Allergic Reaction|Beta Lactam Adverse Reaction |
Fondation Hôpital Saint-Joseph |
2022-10-28 | -- |
| NCT05604157 | Recruiting | Infections Joint Prosthetic |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2021-09-16 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).