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Anti-Infective Completed with Results

Aztreonam (AZLI) in Infants and Children with CF and New Onset Pseudomonas Aeruginosa (Gilead GS-US-205-0162)

This was an open-label, multi-center trial looking at the safety and effectiveness of Aztreonam Inhalation Solution (Cayston®) given to infants and children with CF, ages 3 months to 17 years, who had a newly detected Pseudomonas aeruginosa lung infection in respiratory cultures. Study participants were given a 28-day course of Cayston® taken 3 times a day. After completing this 28-day course of treatment, study participants had respiratory cultures taken over a 6 month follow-up period.

 

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    3 Months to 17 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    90% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Documented new onset of positive lower respiratory tract culture for PA within 30 days prior to study entry

Study Results

  • What We Learned:

    Study results show that approximately half of the study participants remained culture negative for Pseudomonas aeruginosa throughout the post-treatment follow-up period. Additionally, there were no serious safety concerns associated with Aztreonam Inhalation Solution treatment.

  • Primary Findings:

    Effectiveness:

    This open-label study was conducted in the U.S. and Europe between October 2011 and June 2013. A total of 105 pediatric patients were enrolled and 101 completed treatment. Of 79 patients who were evaluated for the primary endpoint, 46 patients (58.2%) remained culture negative for Pseudomonas aeruginosa throughout the 6-month follow-up period.

     

    Of the patients who completed treatment, 89.1% were free of Pseudomonas aeruginosa at the end of treatment and 75.2% were free of Pseudomonas aeruginosa 4 weeks after the end of treatment.

    Safety:

    Aztreonam Inhalation Solution was well-tolerated. The most commonly reported adverse events were cough (41.0%), fever (14.3%), and runny nose (9.5%).

  • Citation:

    J Cyst Fibros ;DOI 10.1016/j.jcf.2014.06.003

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    6 months

  • Number of Study Visits:

    5

Additional Information

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    3 Months to 17 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    90% or greater

  • Pseudomonas Status:

    Positive Respiratory Cultures Required

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Documented new onset of positive lower respiratory tract culture for PA within 30 days prior to study entry

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