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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

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 551 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 Lefamulin (BC 3781) Versus Moxifloxacin (With or Without Adjunctive Linezolid) in Adults With Community-Acquired Bacterial Pneumonia
Study Start Date : September 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Lefamulin
Intravenous lefamulin with potential step-down to oral lefamulin
Drug: lefamulin
antibacterial agent
Other Name: BC-3781

Active Comparator: Moxifloxacin +/- Linezolid
Intravenous moxifloxacin with potential step-down to oral moxifloxacin +/- linezolid
Drug: Moxifloxacin
antibacterial agent
Other Name: Avelox

Drug: Linezolid
antibacterial agent
Other Name: Zyvox




Primary Outcome Measures :
  1. Early Clinical Response [ Time Frame: 96 hours after the first dose of study drug ]
    Assessment of clinical signs and symptoms of pneumonia


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Safety and tolerability [ Time Frame: From screening to 30 days post 1st dose ]
    Evaluation of adverse events 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:

  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.

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): NCT02559310


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Locations
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United States, Kentucky
Site 1006
Hazard, Kentucky, United States, 41701
United States, Louisiana
Site 1008
Shreveport, Louisiana, United States, 71103
United States, Minnesota
Site 1005
Minneapolis, Minnesota, United States, 55415
United States, Montana
Site 1001
Butte, Montana, United States, 59701
United States, Ohio
Site 1009
Akron, Ohio, United States, 44309
Site 1002
Dayton, Ohio, United States, 45402
United States, Texas
Site 1004
Splendora, Texas, United States, 77372
Argentina
Site 3005
La Plata, Buenos Aires, Argentina, 1900
Site 3006
Rosario, Santa Fe, Argentina, S2000CVB
Site 3004
Cordoba, Argentina, X5016KEH
Site 3003
Córdoba, Argentina, X5000EPU
Site 3007
Córdoba, Argentina, X5000JRD
Site 3001
Córdoba, Argentina, X5004CDT
Bosnia and Herzegovina
Site 4003
Mostar, Bosnia and Herzegovina, 88000
Site 4001
Tuzla, Bosnia and Herzegovina, 75000
Site 4004
Zenica, Bosnia and Herzegovina, 72000
Brazil
Site 3104
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Site 3102
Passo Fundo, Rio Grande Do Sol, Brazil, 99010-080
Site 3103
Campinas, Sao Paulo, Brazil, 13059-900
Site 3101
Sao Paulo Do Rio Preto, Sao Paulo, Brazil, 15090-000
Bulgaria
Site 4105
Gabrovo, Bulgaria, 5300
Site 4107
Lovech, Bulgaria, 5500
Site 4112
Pernik, Bulgaria, 2300
Site 4103
Ruse, Bulgaria, 7002
Site 4108
Smolyan, Bulgaria, 4700
Site 4102
Sofia, Bulgaria, 1202
Site 4101
Sofia, Bulgaria, 1233
Site 4106
Sofia, Bulgaria, 1233
Site 4110
Sofia, Bulgaria, 1606
Site 4111
Sofia, Bulgaria, 1606
Site 4104
Veliko Tarnovo, Bulgaria, 5000
Site 4109
Vidin, Bulgaria, 3700
Georgia
Site 4206
Tbilisi, Georgia, 0101
Site 4204
Tbilisi, Georgia, 0144
Site 4205
Tbilisi, Georgia, 0144
Site 4201
Tbilisi, Georgia, 0159
Site 4202
Tbilisi, Georgia, 0186
Hungary
Site 4305
Budapest, Hungary, 1121
Site 4306
Csorna, Hungary, 9300
Site 4304
Debrecen, Hungary, 4043
Site 4302
Farkasgyepű, Hungary, 8582
Site 4307
Miskolc, Hungary, 3529
Site 4308
Miskolc, Hungary, 3529
Site 4303
Törökbálint, Hungary, 2045
Latvia
Site 4403
Daugavpils, Latvia, LV-5417
Site 4401
Liepaja, Latvia, LV-3414
Site 4402
Riga, Latvia, LV-1038
Netherlands
Site 4603
Almelo, Overijssel, Netherlands, 7609 PP
Site 4602
Helmond, Netherlands, 5707 HA
Peru
Site 3205
Trujillo, La Libertad, Peru
Site 3202
Lima, Peru, Lima 18
Site 3204
Lima, Peru, Lima 1
Site 3201
Lima, Peru, Lima 29
Philippines
Site 2005
Iloilo City, Philippines, 5000
Site 2003
Manila City, Philippines, 1000
Site 2004
Manila, Philippines, 1012
Site 2002
Quezon City, Philippines, 1100
Site 2001
Quezon City, Philippines, 1114
Poland
Site 4703
Skierniewice, Lódzkie, Poland, 96-100
Site 4704
Warszawa, Mazowieckie, Poland, 02-097
Site 4701
Lódz, Poland, 90-153
Site 4702
Wilkowice, Poland, 43-365
Romania
Site 4802
Palazu Mare, Constanta, Romania, 900002
Site 4801
Bucharest, Romania, 21105
Site 4806
Bucharest, Romania, 21105
Site 4810
Bucuresti, Romania, 030303
Site 4811
Cluj-Napoca, Romania, 040000
Site 4803
Craiova, Romania, 200515
Site 4808
Craiova, Romania, 200515
Site 4807
Timisoara, Romania, 300310
Site 4809
Timisoara, Romania, 300310
Russian Federation
Site 4904
Chelyabinsk, Russian Federation, 454021
Site 4902
Novosibirsk, Russian Federation, 630102
Site 4906
Smolensk, Russian Federation, 214019
Site 4903
St. Petersburg, Russian Federation, 191163
Site 4901
St. Petersburg, Russian Federation, 197706
Site 4905
Yaroslavl, Russian Federation, 150062
Serbia
Site 5003
Nis, Nišavski Okrug, Serbia, 18204
Site 5002
Belgrade, Serbia, 11000
Site 5004
Sremska Kamenica, Serbia, 11080
Site 5001
Kragujevac, Šumadijski Okrug, Serbia, 34000
South Africa
Site 5103
Benoni, Gauteng, South Africa, 1500
Site 5104
Pretoria, Gauteng, South Africa, 181
Site 5105
Thabazimbi, Limpopo, South Africa, 380
Site 5101
Middelburg, Mpumalanga, South Africa, 1050
Site 5102
Krugersdorp, South Africa, 1724
Thailand
Site 2103
Nonthaburi, Thailand, 10110
Ukraine
Site 5203
Chernivtsi, Chernivets'ka Oblast, Ukraine, 58005
Site 5204
Ivano-Frankivsk, Ivano-Frankivs'ka Oblast, Ukraine, 76018
Site 5201
Kharkiv, Kharkivs'ka Oblast, Ukraine, 61124
Site 5209
Kherson, Khersons'ka Oblast, Ukraine, 73000
Site 5211
Odesa, Odes'ka Oblast, Ukraine, 65025
Site 5210
Zaporizhzhia, Zaporiz'ka Oblast, Ukraine, 69118
Site 5202
Kyiv, Ukraine, 01133
Site 5205
Kyiv, Ukraine, 03680
Site 5207
Kyïv, Ukraine, 03680
Site 5208
Sumy, Ukraine, 40022
Site 5212
Zaporizhzhia, Ukraine, 69035
Site 5206
Zhytomyr, Ukraine, 10002
Sponsors and Collaborators
Nabriva Therapeutics AG
Investigators
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Study Chair: Jennifer Schranz, MD Nabriva Therapeutics

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Responsible Party: Nabriva Therapeutics AG
ClinicalTrials.gov Identifier: NCT02559310     History of Changes
Other Study ID Numbers: NAB-BC-3781-3101
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Keywords provided by Nabriva Therapeutics AG:
Pneumonia
CABP
CAP
Community acquired bacterial pneumonia
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Linezolid
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
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
Protein Synthesis Inhibitors