Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia
LEAP2
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
1 other identifier
interventional
738
20 countries
155
Brief Summary
This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate 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 Aug 2016
155 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
First Submitted
Initial submission to the registry
June 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedResults Posted
Study results publicly available
October 23, 2019
CompletedOctober 23, 2019
September 1, 2019
1.4 years
June 20, 2016
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 for the treatment of CABP through the ECR assessment
96 hours +/- 24 hours after first dose of study drug
Secondary Outcomes (1)
Investigator's Assessment of Clinical Response (IACR)
IACR was assessed at the Test-of-Cure Visit; 5 to 10 days after last dose of study drug
Study Arms (2)
lefamulin
EXPERIMENTALoral lefamulin, 600mg
Moxifloxacin
ACTIVE COMPARATORoral moxifloxacin, 400mg
Interventions
Eligibility Criteria
You may qualify if:
- Each subject must:
- 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 (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.
- 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).
- +4 more criteria
You may not qualify if:
- Each subject must NOT:
- 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., 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).
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (155)
1080
Beverly Hills, California, United States
Site 1065
Fresno, California, 93701, United States
1078
Northridge, California, United States
Site 1072
Oxnard, California, 93030, United States
Site 1070
Sacramento, California, 95817, United States
1079
Sherman Oaks, California, United States
Site 1053
Sylmar, California, 91342, United States
Site 1064
DeBary, Florida, 32713, United States
Site 1052
DeLand, Florida, 32720, United States
1076
Miami, Florida, United States
Site 1051
Michigan City, Indiana, 46360, United States
Site 1057
Natchitoches, Louisiana, 71457, United States
Site 1073
New Bedford, Massachusetts, 02740, United States
Site 1055
Detroit, Michigan, 48201, United States
Site 1062
Detroit, Michigan, 48235, United States
Site 1068
Royal Oak, Michigan, 48073, United States
Site 1058
St Louis, Missouri, 63110, United States
Site 1054
Butte, Montana, 59701, United States
Site 1067
Lima, Ohio, 45801, United States
Site 1056
Rapid City, South Dakota, 57702, United States
1077
Hendersonville, Tennessee, United States
Site 1060
Houston, Texas, 77070, United States
Site 1069
Houston, Texas, 77093, United States
Site 1066
Splendora, Texas, 77372, United States
Site 1059
Charlottesville, Virginia, 22908, United States
Site 3056
Buenos Aires, Argentina
Site 3059
Buenos Aires AV, Argentina
Site 3054
Córdoba, X5000EPU, Argentina
Site 3052
Córdoba, Argentina
Site 3057
Córdoba, Argentina
Site 3058
General Pacheco, Argentina
Site 3051
La Plata, Argentina
Site 3053
La Plata, Argentina
Site 3154
Belo Horizonte, 30150-221, Brazil
Site 3153
Passo Fundo, 99010-080, Brazil
Site 3152
São José do Rio Preto, 15090-000, Brazil
4162
Rousse, 7002, Bulgaria
Site 4154
Sliven, 8800, Bulgaria
Site 4160
Sofia, 1233, Bulgaria
Site 4157
Sofia, 1336, Bulgaria
Site 4153
Sofia, 1606, Bulgaria
Site 4156
Sofia, 1606, Bulgaria
Site 4161
Sofia, 1680, Bulgaria
4163
Sofia, Bulgaria
4164
Sofia, Bulgaria
4165
Sofia, Bulgaria
Site 4158
Stara Zagora, 6000, Bulgaria
Site 4159
Vidin, 3700, Bulgaria
Site 4152
Vratsa, 3000, Bulgaria
Site 3353
Santiago, Chile
Site 3356
Santiago, Chile
Site 3357
Santiago, Chile
Site 3354
Talca, Chile
Site 3352
Temuco, Chile
Site 3355
Valdivia, Chile
Site 4256
Batumi, Georgia
Site 4253
Tbilisi, 101, Georgia
Site 4255
Tbilisi, 159, Georgia
Site 4252
Tbilisi, 179, Georgia
Site 4254
Tbilisi, 186, Georgia
Site 4354
Budapest, 1122, Hungary
Site 4353
Budapest, 1134, Hungary
Site 4352
Mátraháza, 3233, Hungary
Site 4351
Törökbálint, 2045, Hungary
Site 4451
Liepāja, LV3414, Latvia
Site 4453
Riga, LV-1002, Latvia
Site 4452
Valmiera, LV 4201, Latvia
Site 1153
Aguascalientes, 20230, Mexico
Site 1154
Guadalajara, 44280, Mexico
Site 1151
Monterrey, 64460, Mexico
Site 1152
Toluca, 52140, Mexico
Site 3264
Grau, Lima region, Peru
Site 3262
Arequipa, Peru
Site 3263
Cusco, Peru
Site 3261
Cuzco, Peru
Site 3254
Ica, Peru
Site 3259
Iquitos, Peru
Site 3251
La Libertad, Peru
Site 3252
Lima, Peru
Site 3253
Lima, Peru
Site 3255
Lima, Peru
Site 3257
Lima, Peru
Site 3260
Lima, Peru
Site 3265
Lima, Peru
Site 3258
Lima Lima, Peru
Site 3256
Piura, Peru
Site 2053
Caloocan, 1400, Philippines
Site 2055
Cebu, 6000, Philippines
Site 2052
Iloilo City, 5000, Philippines
Site 2054
Quezon, 1109, Philippines
Site 2056
Quezon City, 1100, Philippines
Site 2051
Quezon City, Philippines
Site 4755
Bochnia, 32-700, Poland
Site 4754
Chodzież, 64-800, Poland
Site 4753
Krakow, 31-011, Poland
Site 4756
Krakow, 31-202, Poland
Site 4757
Siedlce, 08-110, Poland
Site 4855
Bucharest, 21105, Romania
Site 4858
Bucharest, 21659, Romania
Site 4854
Bucharest, 30303, Romania
Site 4853
Cluj-Napoca, 400371, Romania
Site 4851
Codlea, 505100, Romania
Site 4857
Craiova, 200515, Romania
Site 4856
Timișoara, 300310, Romania
Site 4953
Barnaul, 656045, Russia
Site 4957
Moscow, 117913, Russia
Site 4952
Moscow, 119192, Russia
Site 4954
Novosibirsk, 6300, Russia
Site 4955
Saint Petersburg, 1962, Russia
Site 4951
Saint Petersburg, 198205, Russia
Site 4959
Saratov, 410053, Russia
Site 4958
Smolensk, 214019, Russia
Site 5052
Belgrade, 11000, Serbia
Site 5056
Belgrade, 11000, Serbia
Site 5051
Belgrade, 11080, Serbia
5057
Belgrade, Serbia
Site 5053
Kamenitz, 21204, Serbia
Site 5055
Knez-Selo, 1820, Serbia
Site 5054
Kragujevac, 34000, Serbia
Site 5151
Bloemfontein, 9301, South Africa
Site 5154
Krugersdorp, 1739, South Africa
Site 5155
Middelburg, 1050, South Africa
Site 5156
Pretoria, South Africa
Site 5152
Queenswood, 186, South Africa
Site 5153
Witbank, 1035, South Africa
Site 2254
Uijeongbu-si, Gyeonggi-do, 11765, South Korea
Site 2257
Bucheon-si, 14647, South Korea
Site 2253
Daegu, 42415, South Korea
Site 2255
Seoul, 143-914, South Korea
Site 2256
Seoul, 152-703, South Korea
Site 2251
Seoul, 2259, South Korea
Site 2252
Seoul, 7985, South Korea
Site 4554
Alicante, 3203, Spain
Site 4556
Badalona, 8916, Spain
Site 4552
Barcelona, 8003, Spain
Site 4555
Barcelona, 8035, Spain
Site 4553
Madrid, 28040, Spain
Site 4551
Madrid, 28046, Spain
Site 2352
Kaohsiung City, 82445, Taiwan
Site 2351
Kaohsiung City, Taiwan
Site 2354
Taipei, Taiwan
Site 5264
Chernivtsi, 58001, Ukraine
Site 5261
Ivano-Frankivsk, 76018, Ukraine
Site 5258
Ivano-Frankivsk, 7601, Ukraine
Site 5256
Kharkiv, 61124, Ukraine
Site 5254
Kharkiv, 61157, Ukraine
Site 5255
Kherson, 73000, Ukraine
Site 5263
Kyiv, 1133, Ukraine
SIte 5252
Kyiv, 2091, Ukraine
Site 5251
Kyiv, 3680, Ukraine
Site 5265
Kyiv, 3680, Ukraine
Site 5259
Poltava, 3603, Ukraine
Site 5260
Vinnytsia, 21029, Ukraine
Site 5253
Zaporizhzhya, 69035, Ukraine
Site 5257
Zaporizhzhya, 69065, 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: 33964925DERIVEDAlexander E, Goldberg L, Das AF, Moran GJ, Sandrock C, Gasink LB, Spera P, Sweeney C, Paukner S, Wicha WW, Gelone SP, Schranz J. Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia: The LEAP 2 Randomized Clinical Trial. JAMA. 2019 Nov 5;322(17):1661-1671. doi: 10.1001/jama.2019.15468.
PMID: 31560372DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Schranz, M.D., Chief Medical Officer
- Organization
- Nabriva Therapeutics US, Inc
Study Officials
- STUDY CHAIR
Leanne Gasink, MD
Nabriva Therapeutics AG
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
June 20, 2016
First Posted
June 27, 2016
Study Start
August 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
October 23, 2019
Results First Posted
October 23, 2019
Record last verified: 2019-09