Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia
LEAP
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
1 other identifier
interventional
551
18 countries
99
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2015
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
October 23, 2019
CompletedOctober 23, 2019
October 1, 2019
1.6 years
September 22, 2015
August 28, 2019
October 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early Clinical Response (ECR)
ECR was defined as survival with improvement in at least 2 signs and symptoms of CABP (relative to baseline), no worsening of any CABP sign or symptom, and no use of concomitant antibiotics (other than adjunctive linezolid, as allowed by the study protocol) for the treatment of CABP through the ECR assessment.
ECR was assessed 96 +/- 24 hours after the first dose of study drug.
Secondary Outcomes (2)
Investigator's Assessment of Clinical Response (IACR)
IACR was assessed at the Test-of-Cure visit; 5-10 days after the last dose of study drug.
Investigator's Assessment of Clinical Response (IACR)
IACR was assessed at the Test of Cure visit, 5 - 10 days after the last dose of study drug.
Study Arms (2)
Lefamulin
EXPERIMENTALIntravenous lefamulin with potential step-down to oral lefamulin
Moxifloxacin +/- Linezolid
ACTIVE COMPARATORIntravenous moxifloxacin with potential step-down to oral moxifloxacin +/- linezolid
Interventions
Eligibility Criteria
You may qualify if:
- Be male or female at least 18 years of age.
- Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions.
- 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
- 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)
- 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)
- +3 more criteria
You may not qualify if:
- Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization
- Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens
- 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.
- 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).
- 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).
- Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions).
- Require mechanical ventilation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (99)
Site 1006
Hazard, Kentucky, 41701, United States
Site 1008
Shreveport, Louisiana, 71103, United States
Site 1005
Minneapolis, Minnesota, 55415, United States
Site 1001
Butte, Montana, 59701, United States
Site 1009
Akron, Ohio, 44309, United States
Site 1002
Dayton, Ohio, 45402, United States
Site 1004
Splendora, Texas, 77372, United States
Site 3005
La Plata, Buenos Aires, 1900, Argentina
Site 3006
Rosario, Santa Fe Province, S2000CVB, Argentina
Site 3003
Córdoba, X5000EPU, Argentina
Site 3007
Córdoba, X5000JRD, Argentina
Site 3001
Córdoba, X5004CDT, Argentina
Site 3004
Córdoba, X5016KEH, Argentina
Site 4003
Mostar, 88000, Bosnia and Herzegovina
Site 4001
Tuzla, 75000, Bosnia and Herzegovina
Site 4004
Zenica, 72000, Bosnia and Herzegovina
Site 3104
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Site 3102
Passo Fundo, Rio Grande Do Sol, 99010-080, Brazil
Site 3103
Campinas, São Paulo, 13059-900, Brazil
Site 3101
Sao Paulo Do Rio Preto, São Paulo, 15090-000, Brazil
Site 4105
Gabrovo, 5300, Bulgaria
Site 4107
Lovech, 5500, Bulgaria
Site 4112
Pernik, 2300, Bulgaria
Site 4103
Rousse, 7002, Bulgaria
Site 4108
Smolyan, 4700, Bulgaria
Site 4102
Sofia, 1202, Bulgaria
Site 4101
Sofia, 1233, Bulgaria
Site 4106
Sofia, 1233, Bulgaria
Site 4110
Sofia, 1606, Bulgaria
Site 4111
Sofia, 1606, Bulgaria
Site 4104
Veliko Tarnovo, 5000, Bulgaria
Site 4109
Vidin, 3700, Bulgaria
Site 4206
Tbilisi, 0101, Georgia
Site 4204
Tbilisi, 0144, Georgia
Site 4205
Tbilisi, 0144, Georgia
Site 4201
Tbilisi, 0159, Georgia
Site 4202
Tbilisi, 0186, Georgia
Site 4305
Budapest, 1121, Hungary
Site 4306
Csorna, 9300, Hungary
Site 4304
Debrecen, 4043, Hungary
Site 4302
Farkasgyepű, 8582, Hungary
Site 4307
Miskolc, 3529, Hungary
Site 4308
Miskolc, 3529, Hungary
Site 4303
Törökbálint, 2045, Hungary
Site 4403
Daugavpils, LV-5417, Latvia
Site 4401
Liepāja, LV-3414, Latvia
Site 4402
Riga, LV-1038, Latvia
Site 4603
Almelo, Overijssel, 7609 PP, Netherlands
Site 4602
Helmond, 5707 HA, Netherlands
Site 3205
Trujillo, La Libertad, Peru
Site 3202
Lima, Lima 18, Peru
Site 3204
Lima, Lima 1, Peru
Site 3201
Lima, Lima 29, Peru
Site 2005
Iloilo City, 5000, Philippines
Site 2003
Manila, 1000, Philippines
Site 2004
Manila, 1012, Philippines
Site 2002
Quezon City, 1100, Philippines
Site 2001
Quezon City, 1114, Philippines
Site 4703
Skierniewice, Lódzkie, 96-100, Poland
Site 4704
Warsaw, Masovian Voivodeship, 02-097, Poland
Site 4701
Lódz, 90-153, Poland
Site 4702
Wilkowice, 43-365, Poland
Site 4802
Palazu Mare, Constanța County, 900002, Romania
Site 4810
Bucharest, 030303, Romania
Site 4801
Bucharest, 21105, Romania
Site 4806
Bucharest, 21105, Romania
Site 4811
Cluj-Napoca, 040000, Romania
Site 4803
Craiova, 200515, Romania
Site 4808
Craiova, 200515, Romania
Site 4807
Timișoara, 300310, Romania
Site 4809
Timișoara, 300310, Romania
Site 4904
Chelyabinsk, 454021, Russia
Site 4902
Novosibirsk, 630102, Russia
Site 4903
Saint Petersburg, 191163, Russia
Site 4901
Saint Petersburg, 197706, Russia
Site 4906
Smolensk, 214019, Russia
Site 4905
Yaroslavl, 150062, Russia
Site 5003
Niš, Nišavski Okrug, 18204, Serbia
Site 5002
Belgrade, 11000, Serbia
Site 5004
Kamenitz, 11080, Serbia
Site 5001
Kragujevac, Šumadijski Okrug, 34000, Serbia
Site 5103
Benoni, Gauteng, 1500, South Africa
Site 5104
Pretoria, Gauteng, 181, South Africa
Site 5105
Thabazimbi, Limpopo, 380, South Africa
Site 5101
Middelburg, Mpumalanga, 1050, South Africa
Site 5102
Krugersdorp, 1724, South Africa
Site 2103
Nonthaburi, 10110, Thailand
Site 5203
Chernivtsi, Chernivtsi Oblast, 58005, Ukraine
Site 5204
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine
Site 5201
Kharkiv, Kharkivs’ka Oblast’, 61124, Ukraine
Site 5209
Kherson, Kherson Oblast, 73000, Ukraine
Site 5211
Odesa, Odesa Oblast, 65025, Ukraine
Site 5210
Zaporizhzhia, Zaporizhzhia Oblast, 69118, Ukraine
Site 5207
Kiyiv, 03680, Ukraine
Site 5202
Kyiv, 01133, Ukraine
Site 5205
Kyiv, 03680, Ukraine
Site 5208
Sumy, 40022, Ukraine
Site 5212
Zaporizhzhia, 69035, Ukraine
Site 5206
Zhytomyr, 10002, Ukraine
Related Publications (2)
File TM Jr, Alexander E, Goldberg L, Das AF, Sandrock C, Paukner S, Moran GJ. Lefamulin efficacy and safety in a pooled phase 3 clinical trial population with community-acquired bacterial pneumonia and common clinical comorbidities. BMC Pulm Med. 2021 May 8;21(1):154. doi: 10.1186/s12890-021-01472-z.
PMID: 33964925DERIVEDFile TM, Goldberg L, Das A, Sweeney C, Saviski J, Gelone SP, Seltzer E, Paukner S, Wicha WW, Talbot GH, Gasink LB. Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial. Clin Infect Dis. 2019 Nov 13;69(11):1856-1867. doi: 10.1093/cid/ciz090.
PMID: 30722059DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Schranz, MD, Chief Medical Officer
- Organization
- Nabriva Therapeutics US, Inc.
Study Officials
- STUDY CHAIR
Jennifer Schranz, MD
Nabriva Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2015
First Posted
September 24, 2015
Study Start
September 1, 2015
Primary Completion
April 1, 2017
Study Completion
May 1, 2017
Last Updated
October 23, 2019
Results First Posted
October 23, 2019
Record last verified: 2019-10