Several clinical trials evaluate cefoxitin for surgical antibiotic prophylaxis—including in pancreatic cancer and bariatric surgeries—as well as the management of nosocomial infections. Ranging from Phase 3 and Phase 4 to non-phased interventional or observational studies, these initiatives are sponsored by academic and clinical institutions such as Memorial Sloan Kettering Cancer Center and Poitiers University Hospital. Across these registered records, recruitment statuses encompass completed, active not recruiting, and unknown status.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04775238 | Unknown status | Nosocomial Infections |
Sohag University |
2021-02-27 | Not Applicable |
| NCT03269994 | Active not recruiting | Pancreatic Cancer|Pancreas Cancer|Pancreatic Diseases |
Memorial Sloan Kettering Cancer Center|Indiana University|Massachusetts General Hospital|Thomas Jefferson University|Washington University School of Medicine|Advocate Illinois Masonic Medical Center|Baptist Memorial Health Care Corporation|Baylor Scott and White Health|The Cleveland Clinic|Emory University|Fox Chase Cancer Center|Gundersen Lutheran Medical Center|Hackensack Meridian Health|Hamilton Health Sciences Center|Intermountain Health Care Inc.|Jersey Shore Medical Center (Hackensack Meridian)|Johns Hopkins University|Montefiore Medical Center/Albert Einstein College of Medicine|North Shore University HealthSystem|Milton S. Hershey Medical Center|Rhode Island Hospital|Stony Brook Medicine|Sunnybrook Health Sciences Centre Canada|Temple University|The Ohio State University Wexner Medical Center|The Ottowa Hospital/University of Ottowa|University of California Davis|University of Chicago|University of Iowa|University of Texas Southwestern Medical Center|University of Utah|University of Wisconsin Madison|Providence Health & Services|Albany Medical College|Northwestern University|Universtiy of Mississippi Medical Center|Mount Sinai Hospital New York|Brody School of Medicine at East Carolina University |
2017-11-21 | Phase 3 |
| NCT03306290 | Completed | Obese|Antibiotic Prophylaxis|Bariatric Surgery Candidate |
Central Hospital Nancy France |
2017-10-30 | Not Applicable |
| NCT02703857 | Completed | Antibiotic Prophylaxis Surgery |
Poitiers University Hospital |
2016-02 | Phase 4 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
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>).