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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
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.
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 If a specific trial listing for this trial is available, a link to the specific listing will be present in the "More Information" section below.
Sponsor Contact Information:
Trial Specific Link on
Clinical Research Terms Glossary: Click here
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.
  • Arkansas Children's Hospital (Pediatric), Little Rock, AR, 72202
    Contact Information:
        Ramsey, Lacey LeAnn
        Phone: (501) 364-2391
  • Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
    Contact Information:
        DeLuca, Elizabeth
        Phone: (904) 697-3804
  • Emory University (Pediatric), Atlanta, GA, 30322
    Contact Information:
        Hunter, Eric
        Phone: (404) 785-3102
  • University of Iowa (Pediatric), Iowa City, IA, 52242
    Contact Information:
        Teresi, Mary
        Phone: (319) 384-7546
  • Saint Luke's Cystic Fibrosis Center of Idaho (Pediatric), Boise, ID, 83712
    Contact Information:
        Durham, Dixie
        Phone: (208) 381-7334
  • Ann and Robert H. Lurie Children's Hospital of Chicago (Pediatric), Chicago, IL, 60611
    Contact Information:
        Singh, Noopur
        Phone: (312) 227-6861
  • Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
    Contact Information:
        Bendy, Lisa
        Phone: (317) 948-7152
  • Maine Medical Partners Pediatric Specialty Care (Pediatric), Portland, ME, 04102
    Contact Information:
        Milliard, Carrie
        Phone: (207) 662-6712
  • Children's Hospital of Michigan (Pediatric), Detroit, MI, 48201
    Contact Information:
        Van Wagnen, Catherine
        Phone: (313) 745-4737
  • The Children's Mercy Hospital (Pediatric and Adult), Kansas City, MO, 64108
    Contact Information:
        Schmoll, Candy
        Phone: (816) 701-1339
  • Cardinal Glennon Children's Medical Center (St. Louis University) (Pediatric), St. Louis, MO, 63104
    Contact Information:
        Cooper, Amy
        Phone: (314) 678-5457
  • St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
    Contact Information:
        Hicks, Tina
        Phone: (314) 747-2707
  • St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
    Contact Information:
        Rodgers, Denise
        Phone: (314) 286-1176
  • St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
    Contact Information:
        Burks, Patricia
        Phone: (314) 454-5175
  • University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
    Contact Information:
        Barlow, Carol
        Phone: (919) 966-9146
  • SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
    Contact Information:
        Lindner, Donna
        Phone: (315) 464-7525
  • Children's Hospital Medical Center of Akron (Pediatric), Akron, OH, 44308
    Contact Information:
        Ouellette, Deborah
        Phone: (330) 543-3089
  • Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
    Contact Information:
        Gilmore, Diana
        Phone: (614) 722-4752
  • Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
    Contact Information:
        Kitch, Diane
        Phone: (717) 531-5646
  • Dell Children's Medical Center of Central Texas (Pediatric and Adult), Austin, TX, 78723
    Contact Information:
        Brazil, Isolde
        Phone: (512) 380-9200 X65343
  • Children's Hospital of the King's Daughters (Pediatric), Norfolk, VA, 23507
    Contact Information:
        Buescher, Christine
        Phone: (757) 668-6416
  • Seattle Children's Hospital (Pediatric), Seattle, WA, 98105
    Contact Information:
        McNamara, Sharon
        Phone: (206) 987-3921 X1
  • Children's Hospital of Wisconsin Froedtert & Medical College of Wisconsin (Pediatric), Milwaukee, WI, 53201
    Contact Information:
        Kump, Theresa
        Phone: (414) 337-7144
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