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| Sponsored by: |
FDA Office of Orphan Products Development |
| Information provided by: | FDA Office of Orphan Products Development |
| ClinicalTrials.gov Identifier: | NCT00004829 |
Purpose
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 |
|
Cystic Fibrosis Bacterial Infection |
Drug: tobramycin |
Phase III |
| Genetics Home Reference related topics: | cystic fibrosis |
| MedlinePlus related topics: | Bacterial Infections Cystic Fibrosis |
| Drug Information available for: | Tobramycin Tobramycin sulfate |
| 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.
Eligibility
| 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:
Contacts and Locations
More Information
| Study ID Numbers: | 199/13390, PATH-PG-TNDS-002/003, PATH-FDR001235 |
| First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004829 |
| Health Authority: | United States: Federal Government |
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