Clinical Trials

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)

Check the Tobramycin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tobramycin selectively binds to the bacterial 30S and 50S ribosomal subunits to block the assembly of the functional 70S complex, thereby inhibiting mRNA translation and driving rapid bactericidal cell death. This targeted disruption of bacterial protein synthesis underlies its therapeutic efficacy in combatting severe Gram-negative bacterial pathogens, particularly *Pseudomonas aeruginosa* pulmonary infections in patients with cystic fibrosis.

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>).

Note: Technical data last updated: Sep 1, 2026.