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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR TOBRAMYCIN

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Clinical Trials for Tobramycin

Trial ID Title Status Sponsor Phase Summary
NCT00004829 Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis Completed FDA Office of Orphan Products Development Phase 3 OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa. II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.
NCT00006280 A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis Completed National Center for Research Resources (NCRR) Phase 2 This study's primary goals are to test the safety and effectiveness of Tobramycin for Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung fluid will be examined for bacteria before and after the 28-day treatment. The amount of bacteria before and after treatment will be compared. This will indicate whether the antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr but contains no medication).
NCT00006280 A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 This study's primary goals are to test the safety and effectiveness of Tobramycin for Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung fluid will be examined for bacteria before and after the 28-day treatment. The amount of bacteria before and after treatment will be compared. This will indicate whether the antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr but contains no medication).
NCT00097773 Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis Completed CF Therapeutics Development Network Coordinating Center Phase 2 Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.
NCT00097773 Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis Completed Cystic Fibrosis Foundation Therapeutics Phase 2 Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Tobramycin

Condition Name

Condition Name for Tobramycin
Intervention Trials
Cystic Fibrosis 45
Cataract 5
Pseudomonas Aeruginosa 4
Conjunctivitis 2
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Condition MeSH

Condition MeSH for Tobramycin
Intervention Trials
Cystic Fibrosis 52
Fibrosis 46
Pseudomonas Infections 16
Respiratory Aspiration 7
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Clinical Trial Locations for Tobramycin

Trials by Country

Trials by Country for Tobramycin
Location Trials
United States 412
Italy 51
Spain 16
France 16
Canada 15
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Trials by US State

Trials by US State for Tobramycin
Location Trials
Texas 19
Florida 18
Ohio 18
Pennsylvania 18
New York 18
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Clinical Trial Progress for Tobramycin

Clinical Trial Phase

Clinical Trial Phase for Tobramycin
Clinical Trial Phase Trials
Phase 4 26
Phase 3 34
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Tobramycin
Clinical Trial Phase Trials
Completed 59
Recruiting 15
Not yet recruiting 10
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Clinical Trial Sponsors for Tobramycin

Sponsor Name

Sponsor Name for Tobramycin
Sponsor Trials
Novartis Pharmaceuticals 15
Cystic Fibrosis Foundation Therapeutics 7
Bausch & Lomb Incorporated 7
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Sponsor Type

Sponsor Type for Tobramycin
Sponsor Trials
Other 94
Industry 61
NIH 5
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