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Sponsored by: |
FDA Office of Orphan Products Development |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004829 |
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.
Condition | Intervention | Phase |
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Cystic Fibrosis Bacterial Infection |
Drug: tobramycin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Estimated Enrollment: | 200 |
Study Start Date: | June 1995 |
Estimated Study Completion Date: | May 1998 |
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy. Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.
Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Documented cystic fibrosis with Pseudomonas aeruginosa present in a sputum or throat culture within 6 months prior to screening
Sweat chloride at least 60 mEq/L
--Prior/Concurrent Therapy--
At least 14 days since prior intravenous or aerosolized tobramycin or other antipseudomonal antibiotic
At least 4 weeks since prior administration of any investigational drug
No concurrent antibiotics by aerosol
--Patient Characteristics--
Renal:
Pulmonary:
Other:
Study ID Numbers: | 199/13390, PATH-PG-TNDS-002/003, PATH-FDR001235 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004829 History of Changes |
Health Authority: | United States: Federal Government |
bacterial infection cardiovascular and respiratory diseases cystic fibrosis |
genetic diseases and dysmorphic syndromes immunologic disorders and infectious disorders rare disease |
Bacterial Infections Anti-Infective Agents Tobramycin Fibrosis Respiration Disorders Rare Diseases Anti-Bacterial Agents |
Digestive System Diseases Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases |
Bacterial Infections Anti-Infective Agents Tobramycin Fibrosis Infection Pharmacologic Actions Anti-Bacterial Agents Digestive System Diseases |
Pathologic Processes Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Therapeutic Uses Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases |