Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia
- Conditions
- Community Acquired Pneumonia
- Interventions
- Registration Number
- NCT02813694
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 738
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).
- 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.
-
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).
-
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.
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moxifloxacin Moxifloxacin oral moxifloxacin, 400mg lefamulin lefamulin oral lefamulin, 600mg
- Primary Outcome Measures
Name Time Method Early Clinical Response (ECR) 96 hours +/- 24 hours after first dose of study drug 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
- Secondary Outcome Measures
Name Time Method 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 IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP
Trial Locations
- Locations (155)
Site 1060
🇺🇸Houston, Texas, United States
Site 1065
🇺🇸Fresno, California, United States
Site 1069
🇺🇸Houston, Texas, United States
1076
🇺🇸Miami, Florida, United States
Site 1068
🇺🇸Royal Oak, Michigan, United States
Site 1054
🇺🇸Butte, Montana, United States
Site 3056
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Site 3054
🇦🇷Cordoba, Argentina
Site 3059
🇦🇷Buenos Aires AV, Argentina
Site 1056
🇺🇸Rapid City, South Dakota, United States
Site 3357
🇨🇱Santiago, Chile
Site 3355
🇨🇱Valdivia, Chile
Site 3258
🇵🇪Lima Lima, Peru
Site 2051
🇵🇭Quezon City, Philippines
Site 4755
🇵🇱Bochnia, Poland
Site 4858
🇷🇴Bucuresti, Romania
Site 5054
🇷🇸Kragujevac, Serbia
Site 5255
🇺🇦Kherson, Ukraine
Site 5265
🇺🇦Kyiv, Ukraine
Site 1057
🇺🇸Natchitoches, Louisiana, United States
Site 3057
🇦🇷Cordoba, Argentina
Site 3053
🇦🇷La Plata, Argentina
Site 4156
🇧🇬Sofia, Bulgaria
4165
🇧🇬Sofia, Bulgaria
Site 3356
🇨🇱Santiago, Chile
Site 3352
🇨🇱Temuco, Chile
Site 4453
🇱🇻Rīga, Latvia
Site 3257
🇵🇪Lima, Peru
Site 2052
🇵🇭Iloilo City, Philippines
Site 4851
🇷🇴Codlea, Romania
Site 4953
🇷🇺Barnaul, Russian Federation
Site 4958
🇷🇺Smolensk, Russian Federation
Site 5052
🇷🇸Belgrade, Serbia
Site 3052
🇦🇷Cordoba, Argentina
4164
🇧🇬Sofia, Bulgaria
Site 4158
🇧🇬Stara Zagora, Bulgaria
Site 4254
🇬🇪Tbilisi, Georgia
Site 3259
🇵🇪Iquitos, Peru
Site 2055
🇵🇭Cebu, Philippines
Site 4854
🇷🇴Bucureşti, Romania
Site 4853
🇷🇴Cluj-Napoca, Romania
Site 5251
🇺🇦Kyiv, Ukraine
Site 5257
🇺🇦Zaporizhzhya, Ukraine
Site 4160
🇧🇬Sofia, Bulgaria
Site 4153
🇧🇬Sofia, Bulgaria
Site 3353
🇨🇱Santiago, Chile
Site 4255
🇬🇪Tbilisi, Georgia
Site 2053
🇵🇭Caloocan City, Philippines
Site 2056
🇵🇭Quezon City, Philippines
Site 4855
🇷🇴Bucureşti, Romania
Site 4856
🇷🇴Timisoara, Romania
Site 4252
🇬🇪Tbilisi, Georgia
Site 4351
🇭🇺Torokbalint, Hungary
Site 4857
🇷🇴Craiova, Romania
Site 5055
🇷🇸Knez Selo, Serbia
Site 5253
🇺🇦Zaporizhzhya, Ukraine
Site 1064
🇺🇸DeBary, Florida, United States
Site 1067
🇺🇸Lima, Ohio, United States
Site 3058
🇦🇷General Pacheco, Argentina
Site 4159
🇧🇬Vidin, Bulgaria
Site 3354
🇨🇱Talca, Chile
Site 4256
🇬🇪Batumi, Georgia
Site 3154
🇧🇷Belo Horizonte, Brazil
Site 2256
🇰🇷Seoul, Korea, Republic of
Site 3251
🇵🇪La Libertad, Peru
Site 3263
🇵🇪Cusco, Peru
Site 4452
🇱🇻Valmiera, Latvia
Site 3261
🇵🇪Cuzco, Peru
Site 1153
🇲🇽Aguascalientes, Mexico
Site 1154
🇲🇽Guadalajara, Mexico
Site 3254
🇵🇪Ica, Peru
Site 1152
🇲🇽Toluca, Mexico
Site 1151
🇲🇽Monterrey, Mexico
Site 3264
🇵🇪Grau, Lima, Peru
Site 3265
🇵🇪Lima, Peru
Site 3252
🇵🇪Lima, Peru
Site 3253
🇵🇪Lima, Peru
Site 3255
🇵🇪Lima, Peru
Site 3260
🇵🇪Lima, Peru
Site 4957
🇷🇺Moscow, Russian Federation
Site 3256
🇵🇪Piura, Peru
Site 2054
🇵🇭Quezon, Philippines
Site 4754
🇵🇱Chodziez, Poland
Site 4757
🇵🇱Siedlce, Poland
Site 4753
🇵🇱Krakow, Poland
Site 4756
🇵🇱Kraków, Poland
Site 5151
🇿🇦Bloemfontein, South Africa
Site 4951
🇷🇺St. Petersburg, Russian Federation
5057
🇷🇸Belgrade, Serbia
Site 4959
🇷🇺Saratov, Russian Federation
Site 4952
🇷🇺Moscow, Russian Federation
Site 4955
🇷🇺St. Petersburg, Russian Federation
Site 4954
🇷🇺Novosibirsk, Russian Federation
Site 5056
🇷🇸Belgrade, Serbia
Site 2352
🇨🇳Kaohsiung, Taiwan
Site 5259
🇺🇦Poltava, Ukraine
Site 5260
🇺🇦Vinnytsya, Ukraine
Site 4552
🇪🇸Barcelona, Spain
Site 5051
🇷🇸Belgrade, Serbia
Site 5156
🇿🇦Pretoria, South Africa
Site 5154
🇿🇦Krugersdorp, South Africa
Site 5053
🇷🇸Sremska Kamenica, Serbia
Site 2351
🇨🇳Kaohsiung, Taiwan
Site 2354
🇨🇳Taipei, Taiwan
Site 4556
🇪🇸Badalona, Spain
Site 5152
🇿🇦Queenswood, South Africa
Site 5153
🇿🇦Witbank, South Africa
Site 5261
🇺🇦Ivano-Frankivs'k, Ukraine
Site 5258
🇺🇦Ivano-Frankivs'k, Ukraine
Site 4553
🇪🇸Madrid, Spain
Site 5256
🇺🇦Kharkiv, Ukraine
Site 5264
🇺🇦Chernivtsi, Ukraine
Site 5254
🇺🇦Kharkiv, Ukraine
Site 5263
🇺🇦Kyiv, Ukraine
SIte 5252
🇺🇦Kyiv, Ukraine
Site 4551
🇪🇸Madrid, Spain
Site 4555
🇪🇸Barcelona, Spain
Site 4554
🇪🇸Alicante, Spain
1080
🇺🇸Beverly Hills, California, United States
Site 1070
🇺🇸Sacramento, California, United States
1078
🇺🇸Northridge, California, United States
1079
🇺🇸Sherman Oaks, California, United States
Site 1052
🇺🇸DeLand, Florida, United States
Site 1051
🇺🇸Michigan City, Indiana, United States
Site 1053
🇺🇸Sylmar, California, United States
Site 1073
🇺🇸New Bedford, Massachusetts, United States
Site 1058
🇺🇸Saint Louis, Missouri, United States
Site 1055
🇺🇸Detroit, Michigan, United States
Site 1062
🇺🇸Detroit, Michigan, United States
Site 1066
🇺🇸Splendora, Texas, United States
1077
🇺🇸Hendersonville, Tennessee, United States
Site 1059
🇺🇸Charlottesville, Virginia, United States
Site 3051
🇦🇷La Plata, Argentina
4162
🇧🇬Ruse, Bulgaria
Site 4154
🇧🇬Sliven, Bulgaria
Site 3152
🇧🇷Sao Jose do Rio Preto, Brazil
Site 3153
🇧🇷Passo Fundo, Brazil
Site 4157
🇧🇬Sofia, Bulgaria
4163
🇧🇬Sofia, Bulgaria
Site 4161
🇧🇬Sofia, Bulgaria
Site 4152
🇧🇬Vratsa, Bulgaria
Site 4253
🇬🇪Tbilisi, Georgia
Site 4353
🇭🇺Budapest, Hungary
Site 4352
🇭🇺Matrahaza, Hungary
Site 4354
🇭🇺Budapest, Hungary
Site 2255
🇰🇷Seoul, Korea, Republic of
Site 2254
🇰🇷Uijeongbu Si, Gyeonggi-do, Korea, Republic of
Site 2251
🇰🇷Seoul, Korea, Republic of
Site 2257
🇰🇷Bucheon-si, Korea, Republic of
Site 2253
🇰🇷Daegu, Korea, Republic of
Site 4451
🇱🇻Liepāja, Latvia
Site 3262
🇵🇪Arequipa, Peru
Site 2252
🇰🇷Seoul, Korea, Republic of
Site 5155
🇿🇦Middelburg, South Africa
Site 1072
🇺🇸Oxnard, California, United States