Numerous clinical trials spanning Phase 1 through Phase 4 evaluate tobramycin across diverse therapeutic indications, encompassing recruiting, completed, and terminated protocols. Primary conditions under evaluation include cystic fibrosis lung disease, *Pseudomonas aeruginosa* respiratory infections, open fracture surgical site infections, prosthetic joint infections, and pharmacokinetics during chronic renal dialysis, with specific focus on aerosolized formulations and prophylactic local applications. These investigations are sponsored by commercial entities and academic medical centers, including Respirion Pharmaceuticals, Massachusetts General Hospital, and Washington University School of Medicine.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05361941 | RECRUITING | Periprosthetic Joint Infections |
Elute, Inc. |
2023-08-31 | |
| NCT05169229 | RECRUITING | Arthroplasty, Replacement, Hip; Osteoarthritis, Hip; Antibiotic Resistant Infection; Prosthetic Joint Infection |
University Hospital, Linkoeping |
2022-04-01 | PHASE2 |
| NCT04678154 | RECRUITING | Post Operative Surgical Site Infection |
Major Extremity Trauma Research Consortium |
2021-05-07 | PHASE3 |
| NCT04964947 | ACTIVE_NOT_RECRUITING | Wound Infection; Fractures, Open; Surgical Site Infection |
Massachusetts General Hospital |
2022-01-10 | PHASE3 |
| NCT06016088 | COMPLETED | Cystic Fibrosis Lung; Respiratory Infections, Recurrent, Chronic; Pseudomonas Aeruginosa |
Respirion Pharmaceuticals Pty Ltd |
2024-04-01 | PHASE1; PHASE2 |
| NCT06093191 | COMPLETED | Bronchiectasis Adult; Pseudomonas Aeruginosa Infection |
Jin-Fu Xu |
2023-10-18 | PHASE4 |
| NCT05849090 | COMPLETED | Infections |
University of Utah |
2023-03-27 | EARLY_PHASE1 |
| NCT07332936 | COMPLETED | Symptomatic Irreversible Pulpitis; Postoperative Endodontic Pain Following Emergency Root Canal Treatment |
Umm Al-Qura University |
2023-07-01 | |
| NCT05607030 | COMPLETED | Prosthetic-joint Infection |
Osteal Therapeutics, Inc. |
2023-01-23 | PHASE2 |
| NCT06404541 | UNKNOWN | Ocular Surface Disease; Dry Eye Syndromes |
Kasr El Aini Hospital |
2024-01-10 | PHASE4 |
| NCT06016088 | Recruiting | Cystic Fibrosis Lung|Respiratory Infections Recurrent Chronic|Pseudomonas Aeruginosa |
Respirion Pharmaceuticals Pty Ltd |
2024-04-01 | Phase 1|Phase 2 |
| NCT04560179 | COMPLETED | Bronchopulmonary Dysplasia |
Erik Allen Jensen |
2022-03-22 | PHASE1 |
| NCT05429671 | COMPLETED | Total Knee Arthoplasty |
Rothman Institute Orthopaedics |
2022-06-20 | PHASE3 |
| NCT04872400 | COMPLETED | Fractures, Open; Wounds and Injuries--Infections; Anti-Bacterial Agents; Fractures, Bone; Extremity Fracture Lower; Extremity Fractures Upper |
University of Colorado, Denver |
2021-06-14 | PHASE4 |
| NCT02819856 | COMPLETED | Ototoxicity |
Sound Pharmaceuticals, Incorporated |
2017-07-21 | PHASE2 |
| NCT04662632 | COMPLETED | Prosthetic Joint Infection |
Osteal Therapeutics, Inc. |
2021-11-01 | PHASE2 |
| NCT05076955 | UNKNOWN | Diabetic Foot Ulcer |
University of Mississippi Medical Center |
2021-03-31 | EARLY_PHASE1 |
| NCT05169229 | Recruiting | Arthroplasty Replacement Hip|Osteoarthritis Hip|Antibiotic Resistant Infection|Prosthetic Joint Infection |
University Hospital Linkoeping|Region Östergötland|The Swedish Research Council |
2022-04-01 | Phase 2|Phase 3 |
| NCT04964947 | Recruiting | Wound Infection|Fractures Open|Surgical Site Infection |
Massachusetts General Hospital|United States Department of Defense |
2022-01-10 | Phase 3 |
| NCT05353101 | COMPLETED | Vernal Keratoconjunctivitis; Cyclosporine 0.05% Eye Drops |
Second Affiliated Hospital of Nanchang University |
2020-07-01 | PHASE1 |
| NCT03715322 | UNKNOWN | Bronchiectasis Adult; Pseudomonas Infections |
Guangzhou Institute of Respiratory Disease |
2018-10-26 | PHASE3 |
| NCT03673956 | COMPLETED | Chronic Rhinosinusitis (Diagnosis) |
Mayo Clinic |
2018-09-26 | PHASE1; PHASE2 |
| NCT02528123 | COMPLETED | Myopia; Refractive Errors |
London Vision Clinic |
2016-04 | |
| NCT03485456 | UNKNOWN | Cystic Fibrosis |
University Medical Center Groningen |
2019-05-29 | PHASE1; PHASE2 |
| NCT02717871 | COMPLETED | Keratitis; Infectious Disease (Manifestation) |
University Hospital, Geneva |
2016-03 | PHASE3 |
| NCT02918409 | COMPLETED | Cystic Fibrosis |
National Jewish Health |
2016-08-26 | PHASE4 |
| NCT03721328 | COMPLETED | Prosthetic Joint Infection |
Osteal Therapeutics, Inc. |
2018-10-26 | PHASE2 |
| NCT04297631 | COMPLETED | Antibotics in Cementless Knees |
Washington University School of Medicine |
2020-02-14 | PHASE4 |
| NCT02440828 | COMPLETED | Ventilator Associated Pneumonia (VAP) |
Erasmus Medical Center |
2015-03 | PHASE4 |
| NCT02677701 | COMPLETED | Cystic Fibrosis |
Seattle Children's Hospital |
2016-10-21 | PHASE4 |
| NCT04297631 | Completed | Antibotics in Cementless Knees |
Washington University School of Medicine |
2020-02-14 | Phase 4 |
| NCT03066453 | TERMINATED | Cystic Fibrosis |
University Hospital, Lille |
2017-06-13 | PHASE3 |
| NCT03904836 | COMPLETED | Renal Dialysis; Renal Failure, Chronic |
Maisonneuve-Rosemont Hospital |
2019-01-31 | PHASE1 |
| NCT02657473 | COMPLETED | Non-CF Bronchiectasis |
Medical Center Alkmaar |
2016-08-13 | PHASE2; PHASE3 |
| NCT02873806 | COMPLETED | Open-angle Glaucoma |
Glaukos Corporation |
2013-03 | PHASE4 |
| NCT03928522 | COMPLETED | Total Knee Replacement |
Washington University School of Medicine |
2019-01-28 | PHASE4 |
| NCT03975374 | UNKNOWN | Blepharo Conjunctivitis |
Sutphin Drugs |
2019-06-15 | EARLY_PHASE1 |
| NCT02497365 | COMPLETED | Bacterial Keratitis |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2015-09 | |
| NCT03308253 | UNKNOWN | Surgical Site Infection |
McMaster University |
2018-07-16 | PHASE4 |
| NCT02712983 | COMPLETED | Non-cystic Fibrosis Bronchiectasis |
Novartis Pharmaceuticals |
2017-02-08 | PHASE2 |
| NCT03502070 | COMPLETED | Cystic Fibrosis |
Mylan Inc. |
2018-06-26 | PHASE4 |
| NCT03705962 | TERMINATED | Fractures, Open |
University of Virginia |
2015-07 | PHASE3 |
| NCT03904836 | Completed | Renal Dialysis|Renal Failure Chronic |
Maisonneuve-Rosemont Hospital |
2019-01-31 | Phase 1 |
| NCT03739528 | COMPLETED | Cataract |
NTC srl |
2018-09-03 | PHASE3 |
| NCT02054156 | COMPLETED | Cystic Fibrosis |
Bonnie Ramsey |
2014-06 | PHASE3 |
| NCT02526004 | COMPLETED | Cystic Fibrosis |
University College Cork |
2013-10-01 | |
| NCT02888730 | TERMINATED | Cystic Fibrosis; Rhinosinusitis; Lung Diseases |
Virginie ESCABASSE |
2017-02-16 | PHASE3 |
| NCT01740947 | TERMINATED | Colorectal Cancer |
H. Jaap Bonjer, PhD |
2013-01 | PHASE4 |
| NCT02478710 | TERMINATED | Pneumonia, Ventilator-Associated |
Wright State University |
2015-06 | PHASE4 |
| NCT02958514 | COMPLETED | Dry Eye Syndrome |
Peking University Third Hospital |
2016-11 | |
| NCT02489955 | UNKNOWN | Cystic Fibrosis |
The Leeds Teaching Hospitals NHS Trust |
2015-02 | |
| NCT02212587 | COMPLETED | Cystic Fibrosis; Burkholderia Cepacia Infection |
Unity Health Toronto |
2014-09 | PHASE1 |
| NCT02102152 | UNKNOWN | Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa |
Rabin Medical Center |
2014-04 | |
| NCT01230593 | COMPLETED | Chalazion Unspecified Eye, Unspecified Eyelid; Chalazion Left Eye, Unspecified Eyelid; Chalazion Right Eye, Unspecified Eyelid; Chalazion Both Eyes |
McMaster University |
2010-11 | |
| NCT03341741 | COMPLETED | Cystic Fibrosis With Pulmonary Manifestations |
University Hospital Tuebingen |
2014-03-11 | PHASE3 |
| NCT02269969 | COMPLETED | Burns; Infection |
Sandra Walker |
2015-03 | PHASE1; PHASE2 |
| NCT01844778 | COMPLETED | Cystic Fibrosis |
Novartis Pharmaceuticals |
2013-08 | PHASE4 |
| NCT02734459 | COMPLETED | Bilateral Cataract |
Semler Research Center Pvt. Ltd. |
2013-11 | PHASE3 |
| NCT01082367 | COMPLETED | Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients |
Novartis Pharmaceuticals |
2010-04 | PHASE3 |
| NCT01570192 | TERMINATED | Bacterial Pneumonia |
University of Florida |
2010-09 | PHASE2 |
| NCT02178540 | COMPLETED | Cystic Fibrosis |
Novartis Pharmaceuticals |
2014-08 | PHASE4 |
| NCT01641822 | COMPLETED | Cystic Fibrosis |
Gilead Sciences |
2012-12 | PHASE3 |
| NCT01677403 | UNKNOWN | Bronchiectasis |
Shandong University |
2012-08 | PHASE4 |
| NCT02035488 | COMPLETED | Bronchiectasis |
University Medical Center Groningen |
2013-10 | PHASE1; PHASE2 |
| NCT02015663 | TERMINATED | Cystic Fibrosis |
Novartis Pharmaceuticals |
2014-01 | PHASE4 |
| NCT01775137 | COMPLETED | Long-term Safety of TIP |
Novartis Pharmaceuticals |
2013-02 | PHASE4 |
| NCT02137161 | COMPLETED | Cataract; Pseudoexfoliation Syndrome |
Azienda USL Reggio Emilia - IRCCS |
2013-11 | PHASE4 |
| NCT02207426 | COMPLETED | Healthy |
Pharmaero ApS |
2014-07 | PHASE1 |
| NCT01519661 | COMPLETED | Pulmonary Infections; Pseudomonas Aeruginosa in Cystic Fibrosis |
Novartis Pharmaceuticals |
2012-01 | PHASE4 |
| NCT01953367 | COMPLETED | Cystic Fibrosis |
Pari Pharma GmbH |
2013-09 | PHASE1 |
| NCT01315678 | COMPLETED | Pseudomonas Aeruginosa Infection |
Insmed Incorporated |
2012-02-29 | PHASE3 |
| NCT01456780 | COMPLETED | Meibomian Gland Dysfunction; Posterior Blepharitis |
Massachusetts Eye and Ear Infirmary |
2011-08 | PHASE4 |
| NCT01560962 | TERMINATED | Blepharitis |
Southern California Institute for Research and Education |
2012-01 | |
| NCT01270347 | COMPLETED | Cystic Fibrosis |
Amgen |
2011-01 | PHASE3 |
| NCT01608555 | COMPLETED | Cystic Fibrosis |
University of Milan |
2012-01 | PHASE4 |
| NCT01207245 | COMPLETED | Cystic Fibrosis |
University of Nottingham |
2011-05 | PHASE4 |
| NCT01069705 | COMPLETED | Pulmonary Infections; Pseudomonas Aeruginosa |
Novartis Pharmaceuticals |
2010-02-12 | PHASE3 |
| NCT00982930 | COMPLETED | Pseudomonas Aeruginosa; Cystic Fibrosis |
Novartis Pharmaceuticals |
2009-08-12 | PHASE3 |
| NCT01337219 | UNKNOWN | Cystic Fibrosis |
Erempharma |
2011-04 | PHASE1; PHASE2 |
| NCT01111383 | COMPLETED | Cystic Fibrosis |
Chiesi Farmaceutici S.p.A. |
2009-09 | PHASE3 |
| NCT00918957 | COMPLETED | Cystic Fibrosis |
Novartis Pharmaceuticals |
2009-06 | PHASE3 |
| NCT01155999 | COMPLETED | Purulent Bacterial Conjunctivitis |
Laboratoires Thea |
2008-12 | PHASE3 |
| NCT01227915 | UNKNOWN | Acute Bacterial Conjunctivitis |
Azidus Brasil |
2011-02 | PHASE3 |
| NCT00774072 | COMPLETED | Cystic Fibrosis; Pseudomonas Aeruginosa |
University of Jena |
2008-10 | PHASE2 |
| NCT01044719 | UNKNOWN | Cystic Fibrosis |
Imperial College London |
2010-01 | PHASE4 |
| NCT01400750 | COMPLETED | Cystic Fibrosis |
Universitaire Ziekenhuizen KU Leuven |
2001-08 | PHASE4 |
| NCT00757237 | COMPLETED | Cystic Fibrosis |
Gilead Sciences |
2008-08 | PHASE3 |
| NCT00885365 | COMPLETED | Cystic Fibrosis |
Chiesi Farmaceutici S.p.A. |
2009-04 | PHASE3 |
| NCT00705159 | COMPLETED | Conjunctivitis |
Bausch & Lomb Incorporated |
2008-06 | PHASE4 |
| NCT00794586 | COMPLETED | Cystic Fibrosis |
Gilead Sciences |
2008-11 | PHASE2 |
| NCT01028027 | COMPLETED | Conjunctivitis; Keratitis; Blepharitis |
Bausch & Lomb Incorporated |
2009-10 | PHASE3 |
| NCT01103401 | COMPLETED | Cataract |
Veroia General Hospital |
2009-10 | |
| NCT00097773 | COMPLETED | Cystic Fibrosis; Pulmonary Disease, Chronic Obstructive |
Seattle Children's Hospital |
2004-09 | PHASE2 |
| NCT00992355 | COMPLETED | Cataract |
Veroia General Hospital |
2009-01 | |
| NCT00388505 | COMPLETED | Cystic Fibrosis |
Novartis Pharmaceuticals |
2006-02 | PHASE3 |
| NCT00634192 | COMPLETED | Pseudomonas Infections |
Novartis |
2008-02 | PHASE3 |
| NCT00420628 | COMPLETED | Chalazion; Hordeolum |
Bausch & Lomb Incorporated |
2006-11 | PHASE4 |
| NCT00695435 | COMPLETED | Dry Eye |
Alcon Research |
2008-06 | PHASE1 |
| NCT00823238 | COMPLETED | Cystic Fibrosis |
University of North Carolina, Chapel Hill |
2004-07 | PHASE1 |
| NCT00576251 | COMPLETED | Ocular Inflammation Associated With Blepharaconjunctivitis |
Alcon Research |
2007-10 | PHASE3 |
| NCT00547053 | COMPLETED | Cystic Fibrosis |
Boston Children's Hospital |
2006-12 | PHASE1 |
| NCT00391976 | COMPLETED | Cystic Fibrosis |
Novartis |
2003-11 | PHASE3 |
| NCT00447837 | COMPLETED | Chronic Sinusitis |
Naryx Pharma |
2006-10 | PHASE2 |
| NCT00447577 | COMPLETED | Blepharokeratoconjunctivitis |
Bausch & Lomb Incorporated |
2007-01 | PHASE4 |
| NCT00125346 | TERMINATED | Cystic Fibrosis |
Novartis |
2005-09 | PHASE3 |
| NCT00362895 | COMPLETED | Cataract |
Alcon Research |
2006-04 | PHASE3 |
| NCT00198523 | COMPLETED | Eye Infections; Postoperative Complications |
Bausch & Lomb Incorporated |
2005-07 | PHASE3 |
| NCT00105469 | COMPLETED | Bacterial Conjunctivitis |
Merck Sharp & Dohme LLC |
2004-07 | PHASE3 |
| NCT00532961 | COMPLETED | Inflammation |
Bausch & Lomb Incorporated |
2005-02 | PHASE4 |
| NCT00050401 | COMPLETED | Pneumonia |
Pfizer |
2002-07 | PHASE3 |
| NCT01559753 | COMPLETED | Pneumonia Ventilator Associated |
Centre Hospitalier Universitaire de Besancon |
1998-01 | PHASE4 |
| NCT00257790 | COMPLETED | Neutropenia; Fever; Cancer |
Oslo University Hospital |
2001-09 | PHASE4 |
| NCT00357773 | COMPLETED | Conjunctivitis, Bacterial |
Laboratoires Thea |
2004-05 | PHASE3 |
| NCT01079559 | WITHDRAWN | Infection; Osteoarthritis of the Knee |
University of Western Ontario, Canada |
PHASE3 | |
| NCT00153634 | COMPLETED | Cystic Fibrosis; Chronic Bronchitis |
Seattle Children's Hospital |
2004-03 | |
| NCT00399945 | COMPLETED | Cystic Fibrosis |
Novartis |
2006-05 | PHASE1 |
| NCT00006280 | COMPLETED | Cystic Fibrosis |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2000-02 | PHASE2 |
| NCT00004829 | COMPLETED | Cystic Fibrosis; Bacterial Infection |
FDA Office of Orphan Products Development |
1995-06 | PHASE3 |
| NCT00420836 | COMPLETED | Cystic Fibrosis |
Novartis |
2006-04 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-07-14)
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>).