None listed
Conditions
Interventions
• Lefamulin IV of 150 mg in 15 mL mL concentrate solution for infusion.of 0.9% saline, to be further diluted in 10mM citrate buffered 0.9% saline
• Lefamulin 600 mg of lefamulin as a yellow oval fi
Sponsors
Nabriva Therapeutics AG,
Eligibility
Sex/Gender
All
Age
28 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male/female  18 years of age 2. Provide written IC and be willing and able to adhere to the study-specified procedures and restrictions. 3. Have an acute illness with at least 3 of the following symptoms consistent with a lower respiratory tract infection: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; Hypotension; Tachycardia; Tachypnea 5. Have at least 1 other clinical sign or laboratory finding of CABP: Hypoxemia; Auscultatory and/or percussion findings consistent with pneumonia; White blood cell count >10,000 cells/mm3 or 15% immature neutrophils (bands) regardless of total WBC count 6. Have radiographically-documented pneumonia within 24 hours before enrollment 7. Have a Pneumonia Outcomes Research Team Risk Class ≥III. 8. If female, meets the following criteria: Surgically sterile or ≥2 years postmenopausal, or if of childbearing potential, has a negative pregnancy test, and if participating in sexual activity that may lead to pregnancy, agrees to use an effective dual method of contraception during the study and for ≥28 days after the last dose of study drug 9. If male, meets the following criteria: If not surgically sterile and if participating in sexual activity that may lead to pregnancy, agrees to use an effective dual method of contraception
Exclusion criteria
Exclusion criteria: 1. Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 24 h- before randomization. 2. Require concomitant systemic antibacterial therapy against CABP pathogens 3. Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms 4. Have CABP caused by a pathogen known to be resistant to any of the study drugs 5. Have a noninfectious cause of pulmonary infiltrates 6. Have confirmed or suspected pleural empyema 7. Require mechanical ventilation. 8. Have cardiac events or dysfunction 9. Be receiving a strong p-glycoprotein or CYP3A inducer or inhibitor 10. Have a history of tendon disease/disorder, myasthenia gravis, or known or suspected central nervous system disorders 11. Have a history of any hypersensitivity or allergic reaction to any fluoroquinolone, or any drug in the pleuromutilin class 12. Have severely impaired renal function, defined as creatinine clearance. 13. Have evidence of significant hepatic, hematologic, or immunologic disease including any of the following: 14. Have known or suspected severe immunosuppression, defined as receipt of corticosteroid therapy within the previous 8 w. 15. Life expectancy of ≤3 months because of any disease other than the current episode of CABP 16. Have participated in any study involving administration of an investigational agent or device within 30 days before enrollment. 17. Previously treated with lefamulin or previously enrolled in this study.
Countries
Argentina, Bulgaria, Georgia, Hungary, Latvia, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, South Africa, Thailand, Ukraine, United States
Contacts
Public ContactJuanita Aching
PPD Peru S.A.C.
Outcome results
None listed