Numerous clinical trials, spanning Phase 1 through Phase 4 as well as observational protocols, evaluate the therapeutic utility, dosing, and safety of teicoplanin for conditions such as Gram-positive bacterial pneumonia, Staphylococcus aureus bone and joint infections, catheter-related bacteremia, and cystic fibrosis. Sponsored by academic institutions, university hospitals, and pharmaceutical entities, these studies encompass various recruitment statuses—including completed, recruiting, terminated, and withdrawn trials—aimed at optimizing dosing strategies, assessing drug tissue penetration, and improving outcomes in patients with severe bacterial pathogens.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06818565 | NOT_YET_RECRUITING | Acute-On-Chronic Liver Failure |
Institute of Liver and Biliary Sciences, India |
2025-02-10 | |
| NCT06803758 | RECRUITING | Drug Allergy |
University Hospital Southampton NHS Foundation Trust |
2025-01-08 | |
| NCT06426836 | RECRUITING | Pharmacokinetics; Amoxicillin-clavulanate; Piperacillin-tazobactam; Meropenem; Cefazolin; Teicoplanin; Vancomycin; Ciprofloxacin; Amikacin |
University Hospital, Ghent |
2016-08-19 | |
| NCT05914467 | TERMINATED | Bacterial Infections |
Radboud University Medical Center |
2023-08-01 | PHASE4 |
| NCT02652169 | RECRUITING | Chronic Skin Ulcer |
Medical University of Vienna |
2014-06 | |
| NCT04370145 | COMPLETED | Cholangitis, Secondary Biliary; Treatment Compliance; Antibodies Drug Specific |
Tongji Hospital |
2021-05-01 | PHASE4 |
| NCT03210233 | UNKNOWN | Hypersensitivity |
The Leeds Teaching Hospitals NHS Trust |
2017-03-01 | |
| NCT04003818 | TERMINATED | Clostridium Difficile Infection-associated Diarrhea and Colitis |
Sanofi |
2020-05-15 | PHASE4 |
| NCT04341831 | UNKNOWN | Lumbar Spinal Stenosis; Lumbar Disc Herniation; Scoliosis Lumbar Region; Lumbar Spondylolisthesis; Lumbar Disc Lesion |
Bezmialem Vakif University |
2020-04-15 | PHASE3 |
| NCT04176328 | COMPLETED | Cystic Fibrosis |
Neupharma Srl |
2019-10-25 | PHASE1 |
| NCT03909698 | Completed | Kidney Failure Chronic|Antibiotics|Hemodialysis |
University Hospital Ghent|University Ghent |
2016-09-15 | -- |
| NCT01815541 | COMPLETED | Osteoarticular Infection |
Centre Hospitalier Universitaire, Amiens |
2013-03 | PHASE2 |
| NCT03229135 | Completed | Pneumonia Gram-Positive Bacterial |
People''s Hospital of Zhengzhou University |
2015-02-01 | -- |
| NCT01592032 | UNKNOWN | Catheter-Related Infections; Bacteremia. |
Clinica Universidad de Navarra, Universidad de Navarra |
2012-05 | PHASE4 |
| NCT03177369 | Completed | Teicoplanin-based Antimicrobial Therapy|Staphylococcus Aureus|Bone and Joint Infection |
Hospices Civils de Lyon |
2015-01 | -- |
| NCT02018094 | COMPLETED | Wound Infection; Amputation Wound |
Hull University Teaching Hospitals NHS Trust |
2013-10-08 | PHASE4 |
| NCT00925093 | WITHDRAWN | Neurosurgery |
Aarhus University Hospital |
2011-09 | PHASE1 |
| NCT01324804 | Unknown status | Coronary Heart Disease|Surgical Wound Infection |
Medical University of Vienna |
2010-11 | -- |
| NCT00428844 | COMPLETED | Osteomyelitis |
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2007-06-26 | PHASE2 |
| NCT00024453 | UNKNOWN | Infection |
Children's Cancer and Leukaemia Group |
1999-02 | |
| NCT00754273 | Completed | Methicillin-resistant Staphylococcal Aureus Pneumonia |
University of Kentucky|Pfizer |
2008-09 | -- |
| NCT00430937 | TERMINATED | Skin Diseases, Infectious; Soft Tissue Infections |
Novartis Pharmaceuticals |
2006-04 | PHASE3 |
| NCT00454272 | COMPLETED | Infection; Febrile Neutropenia |
Sanofi |
2005-01 | PHASE4 |
| NCT00719056 | COMPLETED | Total Hip and Knee Arthroplasties |
University of Athens |
2004-08 | PHASE4 |
| NCT00368498 | UNKNOWN | Staphylococcal Infections |
National Taiwan University Hospital |
2006-06 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2025-02-10)
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>).