CLINICAL TRIALS PROFILE FOR TOBRAMYCIN
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All Clinical Trials for TOBRAMYCIN
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT00004829 ↗ | Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis | Completed | FDA Office of Orphan Products Development | Phase 3 | 1995-06-01 | 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 | 2000-02-01 | 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 | 2000-02-01 | 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 | 2004-09-01 | 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 | Phase 2 | 2004-09-01 | 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 | 2004-09-01 | 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 | National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 | 2004-09-01 | 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 | >Start Date | >Summary |
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