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Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia (LEAP)

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ClinicalTrials.gov Identifier: NCT02559310
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Nabriva Therapeutics AG

Tracking Information
First Submitted Date  ICMJE September 22, 2015
First Posted Date  ICMJE September 24, 2015
Last Update Posted Date March 29, 2018
Study Start Date  ICMJE September 2015
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
Early Clinical Response [ Time Frame: 96 hours after the first dose of study drug ]
Assessment of clinical signs and symptoms of pneumonia
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02559310 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
  • Early Clinical Response in the microITT population [ Time Frame: 96 hours after the first dose of study drug ]
    Assessment of clinical signs and symptoms of pneumonia
  • Investigator's Assessment of Clinical Response in the m-ITT and CE populations [ Time Frame: 5 to 10 days after last dose of study drug ]
    Assessment of clinical response
  • Safety and tolerability [ Time Frame: From screening to 30 days post 1st dose ]
    Evaluation of adverse events throughout the study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Lefamulin (BC 3781) Versus Moxifloxacin (With or Without Adjunctive Linezolid) in Adults With Community-Acquired Bacterial Pneumonia
Brief Summary This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.
Detailed Description Lefamulin is a potent, semi-synthetic antibacterial belonging to a novel class known as the pleuromutilins. Both the intravenous (IV) and oral dosage forms of lefamulin are under investigation in this study. Lefamulin's in vitro antibacterial profile includes the most important bacterial pathogens causing respiratory tract infection (RTI). The antibacterial spectrum comprises S. pneumoniae, H. influenzae, M. catarrhalis, the atypical respiratory pathogens L. pneumophila, C. pneumoniae, and M. pneumoniae, S. aureus including MRSA and CA-MRSA, ß-haemolytic streptococci including S. pyogenes and S. agalactiae, and Enterococcus faecium including vancomycin-resistant enterococci (VRE). Moreover, as demonstrated in cross-resistance studies, lefamulin remains active against clinical isolates resistant to the following antimicrobial(s) (classes): macrolides, lincosamides, streptogramin B, oxazolidinones, tetracyclines, ß lactams, quinolones, trimethoprim-sulfametoxazole, mupirocin, and vancomycin.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Community Acquired Pneumonia
Intervention  ICMJE
  • Drug: lefamulin
    antibacterial agent
    Other Name: BC-3781
  • Drug: Moxifloxacin
    antibacterial agent
    Other Name: Avelox
  • Drug: Linezolid
    antibacterial agent
    Other Name: Zyvox
Study Arms  ICMJE
  • Experimental: Lefamulin
    Intravenous lefamulin with potential step-down to oral lefamulin
    Intervention: Drug: lefamulin
  • Active Comparator: Moxifloxacin +/- Linezolid
    Intravenous moxifloxacin with potential step-down to oral moxifloxacin +/- linezolid
    Interventions:
    • Drug: Moxifloxacin
    • Drug: Linezolid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2017)
551
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2015)
738
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Be male or female at least 18 years of age.
  2. Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions.
  3. Have an acute illness (7 days duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening):

    • Dyspnea
    • New or increased cough
    • Purulent sputum production
    • Chest pain due to pneumonia
  4. Have at least 2 of the following vital sign abnormalities:

    • Fever (body temperature >38.0°C (100.4°F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature <35.0°C (95.0°F) measured orally or equivalent temperature from an alternate body site)
    • Hypotension (systolic blood pressure <90 mmHg)
    • Tachycardia (heart rate >100 beats/min)
    • Tachypnea (respiratory rate >20 breaths/min)
  5. Have at least 1 other clinical sign or laboratory finding of CABP:

    • Hypoxemia (i.e., O2 saturation <90% on room air or while receiving supplemental oxygen at subject's baseline requirement or PaO2 <60 mmHg)
    • Auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness)
    • White blood cell (WBC) count >10,000 cells/mm3 or <4500 cells/mm3 or >15% immature neutrophils (bands) regardless of total WBC count
  6. Have radiographically-documented pneumonia within 48 hours before enrollment (i.e., infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray or chest computed tomography scan consistent with acute bacterial pneumonia).
  7. Have a Pneumonia Outcomes Research Team (PORT) Risk Class ≥III.

Exclusion Criteria:

  1. Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization
  2. Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens
  3. Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms. NOTE: Residence in an independent living facility is permitted.
  4. Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs (e.g., Pseudomonas aeruginosa, any pathogen of the Enterobacteriaceae Family) or attributable to etiologies other than community acquired bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other fungal pneumonia, viral or mycobacterial infection of the lung).
  5. Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis).
  6. Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions).
  7. Require mechanical ventilation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Georgia,   Hungary,   Latvia,   Netherlands,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   Serbia,   South Africa,   Thailand,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02559310
Other Study ID Numbers  ICMJE NAB-BC-3781-3101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nabriva Therapeutics AG
Study Sponsor  ICMJE Nabriva Therapeutics AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jennifer Schranz, MD Nabriva Therapeutics
PRS Account Nabriva Therapeutics AG
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP