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Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia (LEAP2)

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ClinicalTrials.gov Identifier: NCT02813694
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Nabriva Therapeutics AG

Brief Summary:
This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate community-acquired bacterial pneumonia

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia Drug: lefamulin Drug: Moxifloxacin Phase 3

Detailed Description:
Lefamulin is a potent, semi-synthetic antibacterial belonging to a novel class known as the pleuromutilins. The oral dosage form of lefamulin is 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 738 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Oral Lefamulin (BC 3781) Versus Oral Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia
Actual Study Start Date : August 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: lefamulin
oral lefamulin, 600mg
Drug: lefamulin
antibacterial agent
Other Name: BC-3781

Active Comparator: Moxifloxacin
oral moxifloxacin, 400mg
Drug: Moxifloxacin
antibacterial agent
Other Name: Avelox




Primary Outcome Measures :
  1. Early Clinical Response: proportion of patients with patient reported improvement in symptoms over time [ Time Frame: 96 hours after first dose of study drug ]
    Assessment of clinical symptoms of pneumonia


Secondary Outcome Measures :
  1. Early Clinical Response in the microbiological intent-to-treat population: proportion of patients with patient reported improvement in symptoms over time [ Time Frame: 96 hours after the first dose of study drug ]
    Assessment of clinical symptoms of pneumonia

  2. Investigator's Assessment of Clinical Response in the modified intent-to-treat and clinically evaluable populations: proportion of patients deemed success based upon improvement in baseline signs and symptoms of disease [ Time Frame: 5 to 10 days after last dose of study drug ]
    Assessment of clinical response

  3. Safety and tolerability: assessment of adverse events, laboratory parameters and vital signs [ Time Frame: From screening to 30 days post first dose ]
    Evaluation of adverse event throughout the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Each subject must:

  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 (less than or equal to 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 < 4 500 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 of II, III, or IV and be an appropriate candidate for oral antibiotic therapy as treatment for the current episode of CABP.

Exclusion Criteria:

Each subject must NOT:

  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., MRSA, 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813694


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Sponsors and Collaborators
Nabriva Therapeutics AG
Investigators
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Study Chair: Leanne Gasink, MD Nabriva Therapeutics AG

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Responsible Party: Nabriva Therapeutics AG
ClinicalTrials.gov Identifier: NCT02813694     History of Changes
Other Study ID Numbers: NAB-BC-3781-3102
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Keywords provided by Nabriva Therapeutics AG:
Pneumonia
CABP
CAP
Community acquired bacterial pneumonia

Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Moxifloxacin
Anti-Bacterial Agents
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs