A PHASE 3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-A CLINICAL 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.

Not Applicable

• Conditions: J159; -J159 Bacterial pneumonia, unspecified; Bacterial pneumonia, unspecified

• Registration Number: PER-075-15
• Lead Sponsor: abriva Therapeutics AG,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 4

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 <4500 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified