Study Name: OPTIMIZE
Study Type: Interventional
Intervention Category: Anti-Infective
Study Sponsor: Ramsey, Bonnie
Study Phase: 3
Recruitment Status: Recruiting
Study Drug(s): Azithromycin
Number of Participants Being Recruited: 274
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this trial is to compare the effects of treatment with tobramcyin solution for inhalation (TIS) with and without azithromycin in people with CF age 6 months to 18 years who have their first isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 weeks. The trial will last up to 20 weeks.
ELIGIBILITY
Age: 6 Months - 18 Years
FEV1: Not Applicable
P. aeruginosa status: Positive
B. cepacia status: Negative
Other Primary Eligibility Requirements:

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/NCT02054156
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.
AR
  • Arkansas Children's Hospital (Pediatric), Little Rock, AR, 72202
    Contact Information:
        Ramsey, Lacey LeAnn
        Phone: (501) 364-2391
        Email: LRamsey@uams.edu
ME
  • Maine Medical Partners Pediatric Specialty Care (Pediatric), Portland, ME, 04102
    Contact Information:
        Milliard, Carrie
        Phone: (207) 662-6712
        Email: millic@mmc.org
MO
  • Cardinal Glennon Children's Medical Center (St. Louis University) (Pediatric), St. Louis, MO, 63104
    Contact Information:
        Cooper, Amy
        Phone: (314) 678-5457
        Email: acoope16@slu.edu
  • St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
    Contact Information:
        Hicks, Tina
        Phone: (314) 747-2707
        Email: Hicks_T@kids.wustl.edu
  • St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
    Contact Information:
        Rodgers, Denise
        Phone: (314) 286-1176
        Email: rodgers@kids.wustl.edu
  • St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
    Contact Information:
        Burks, Patricia
        Phone: (314) 454-5175
        Email: Burks_P@kids.wustl.edu
NC
  • University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
    Contact Information:
        Barlow, Carol
        Phone: (919) 966-9146
        Email: cbarlow@med.unc.edu
NY
  • SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
    Contact Information:
        Lindner, Donna
        Phone: (315) 464-7525
        Email: lindnerd@upstate.edu
OH
  • Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
    Contact Information:
        Gilmore, Diana
        Phone: (614) 722-4752
        Email: Diana.Gilmore@nationwidechildrens.org
PA
  • Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
    Contact Information:
        Kitch, Diane
        Phone: (717) 531-5646
        Email: dkitch@psu.edu
VA
  • Children's Hospital of the King's Daughters (Pediatric), Norfolk, VA, 23507
    Contact Information:
        Buescher, Christine
        Phone: (757) 668-6416
        Email: bueschcr@evms.edu
WA
  • Seattle Children's Hospital (Pediatric), Seattle, WA, 98105
    Contact Information:
        McNamara, Sharon
        Phone: (206) 987-3921 X1
        Email: sharon.mcnamara@seattlechildrens.org
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