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Study Name: Study of Inhaled TOBI for the Treatment of Early Infections of Pseudomonas Aeruginosa in children with CF ages 3 Months to less than 7 Years
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Novartis
Study Phase: 4
Recruitment Status: Recruiting
Study Drug(s): TOBI
Number of Participants Being Recruited: 50
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study will look at the effectiveness of inhaled TOBI treatment for early infections of P. aeruginosa in children with cystic fibrosis ages 3 months to less than 7 years.
ELIGIBILITY
Age: 3 Months - 7 Years
FEV1: Not Applicable
P. aeruginosa status: Positive
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Eligible subjects must have early lower respiratory tract infection with Pa defined by either of the following: The first time Pa is isolated, or Pa isolated after 1 year of negative cultures (documented with at least 2 negative cultures)
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01082367
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
CA
  • Miller Children's Hospital (Pediatric), Long Beach, CA, 90801
    Contact Information:
        O'Donnell, Nan
        Phone: (562) 933-5607
        Email: nodonnell@memorialcare.org
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