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Anti-Infective Completed with Results

Study of Lefamulin in Adults with CF (Nabriva NAB-BC-3781-1014)

This study evaluated the safety and how the body processes Lefamulin, a drug intended to treat infections in the lung, in adults with CF.

 This study was an open label crossover trail. Participants were randomly assigned to receive one dose of Lefamulin by 150 mg intravenous (IV) infusion followed by a second dose in 600 mg oral tablet form within one week, or to receive the tablet and the infusion in opposite sequence.  Researchers studied how the body processes the drug by measuring how much of the drug stays in the body, and also evaluated the safety of Lefamulin. 

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

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

Other Primary Eligibility Criteria

Excludes use of Orkambi® (lumacaftor/ivacaftor) within 28 days prior to Day 1.

Study Results

  • What We Learned:

    Lefamulin was overall safe and well-tolerated. The study did not show significant differences in how the body processes Lefamulin IV infusion compared with oral tablet. 

  • Primary Findings:

    Effectiveness:

    Safety:

    This study was conducted between April 2022 and August 2022.

    This study enrolled 13 participants, all of which completed the treatment period. No serious adverse events were reported.

  • Citation:

    Clin Ther 2024;46(2):96-103

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

    Yes

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    13 days

  • Number of Study Visits:

    6

Additional Information

  • Phase: ?more info

    Phase One

  • Study Sponsor: ?more info

    Nabriva Therapeutics

  • Study Drugs:

    Lefamulin (Xenleta™)

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

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

Other Primary Eligibility Criteria

Excludes use of Orkambi® (lumacaftor/ivacaftor) within 28 days prior to Day 1.

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