Tobramycin

Generic Name
Tobramycin
Brand Names
Bethkis, Kitabis, Tobi, Tobi Podhaler Weekly Kit, Tobradex, Tobrex, Zylet, Tobi Podhaler, Vantobra (previously Tobramycin PARI)
Drug Type
Small Molecule
Chemical Formula
C18H37N5O9
CAS Number
32986-56-4
Unique Ingredient Identifier
VZ8RRZ51VK
Background

Aminoglycosides, many of which are derived directly from Streptomyces spp., are concentration-dependent bactericidal antibiotics with a broad spectrum of activity against Gram-positive and Gram-negative organisms. Inhaled tobramycin is notable for its use in treating chronic Pseudomonas aeruginosa infections in cystic fibrosis patients, as P. aeruginosa is n...

Indication

Inhaled tobramycin is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa, but is not recommended in patients under six years of age, those with forced expiratory volume in 1 second (FEV) <25 or >80% predicted, or in those with Burkholderia cepacia.
...

Associated Conditions
Bacterial Peritonitis, Bone Infection, Cystic fibrosis, Pseudomonas aeruginosa infection, Eye Infections, Inflammation of the External Auditory Canal, Intraabdominal Infections, Lower respiratory tract infection bacterial, Meningitis, Bacterial, Ocular Inflammation, Septicemia gram-negative, Skin and Subcutaneous Tissue Bacterial Infections, Corticosteroid-responsive Disorder of the Ophthalmic, Ear infection-not otherwise specified caused by susceptible bacteria, Ocular bacterial infections, Recurrent Complicated Urinary Tract Infection, Steroid-responsive inflammation
Associated Therapies
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Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis

Phase 4
Completed
Conditions
Interventions
First Posted Date
2012-05-31
Last Posted Date
2012-07-24
Lead Sponsor
University of Milan
Target Recruit Count
10
Registration Number
NCT01608555
Locations
🇮🇹

IRCCS Ospedale Maggiore Policlinico via F. Sforza 35, Milan, Italy

Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis

First Posted Date
2011-07-22
Last Posted Date
2011-08-04
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
61
Registration Number
NCT01400750
Locations
🇧🇪

Department of pediatrics, CF center Uuiversity Hospital Leuven, Leuven, Belgium

Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis

Phase 1
Conditions
Interventions
First Posted Date
2011-04-18
Last Posted Date
2011-04-18
Lead Sponsor
Erempharma
Target Recruit Count
36
Registration Number
NCT01337219
Locations
🇫🇷

Centre de Ressource et de Compétence Mucoviscidose Pédiatrique Centre de Référence Mucoviscidose, Lyon, France

Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis

First Posted Date
2010-10-25
Last Posted Date
2010-10-25
Lead Sponsor
Azidus Brasil
Target Recruit Count
70
Registration Number
NCT01227915
Locations
🇧🇷

LAL Clínica Pesquisa e Desenvolvimento Ltda, Valinhos, São Paulo, Brazil

Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.

First Posted Date
2010-07-02
Last Posted Date
2014-10-29
Lead Sponsor
Laboratoires Thea
Target Recruit Count
286
Registration Number
NCT01155999

A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®

Phase 3
Completed
Conditions
First Posted Date
2010-04-27
Last Posted Date
2020-07-31
Lead Sponsor
Chiesi Farmaceutici S.p.A.
Target Recruit Count
209
Registration Number
NCT01111383
Locations
🇵🇱

I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy, Kielce, Poland

🇵🇱

Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii, Lublin, Poland

🇵🇱

Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj, Rabka Zdroj, Poland

and more 17 locations

Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

First Posted Date
2010-03-08
Last Posted Date
2016-07-15
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
50
Registration Number
NCT01082367
Locations
🇨🇭

Novartis Investigative Site, Zürich, Switzerland

Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis

First Posted Date
2010-01-08
Last Posted Date
2010-04-13
Lead Sponsor
Imperial College London
Target Recruit Count
240
Registration Number
NCT01044719
Locations
🇬🇧

Department of Cystic Fibrosis, Royal Brompton Hospital, London, United Kingdom

Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

First Posted Date
2008-06-25
Last Posted Date
2015-03-24
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
137
Registration Number
NCT00705159
Locations
🇺🇸

Pediatric Ophthalmology of Erie, Erie, Pennsylvania, United States

Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-03-12
Last Posted Date
2017-02-24
Lead Sponsor
Novartis
Target Recruit Count
50
Registration Number
NCT00634192
Locations
🇩🇪

Novartis Investigator Site, Munich, Germany

🇩🇪

Novartis Investigator site, Halle/Saale, Germany

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