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Lefamulin in Patients with Community-Acquired Bacterial Pneumonia Caused by Atypical Respiratory Pathogens: Pooled Results from Two Phase 3 Trials

Title: Lefamulin in Patients with Community-Acquired Bacterial Pneumonia Caused by Atypical Respiratory Pathogens: Pooled Results from Two Phase 3 Trials
Authors: Paukner, Susanne; Mariano, David; Das, Anita F; Moran, Gregory J; Sandrock, Christian; Waites, Ken B; File, Thomas M
Source: Antibiotics, vol 10, iss 12
Publisher Information: eScholarship, University of California
Publication Year: 2021
Collection: University of California: eScholarship
Subject Terms: 3207 Medical Microbiology (for-2020); 32 Biomedical and Clinical Sciences (for-2020); 3202 Clinical Sciences (for-2020); Infectious Diseases (rcdc); Clinical Research (rcdc); Pneumonia (rcdc); Lung (rcdc); Pneumonia & Influenza (rcdc); 6.1 Pharmaceuticals (hrcs-rac); Infection (hrcs-hc); Chlamydia pneumoniae; Legionella pneumophila; Mycoplasma pneumoniae; atypical pathogens; community-acquired bacterial pneumonia; lefamulin; 3214 Pharmacology and pharmaceutical sciences (for-2020)
Time: 1489
Description: Lefamulin was the first systemic pleuromutilin antibiotic approved for intravenous and oral use in adults with community-acquired bacterial pneumonia based on two phase 3 trials (Lefamulin Evaluation Against Pneumonia [LEAP]-1 and LEAP-2). This pooled analysis evaluated lefamulin efficacy and safety in adults with community-acquired bacterial pneumonia caused by atypical pathogens (Mycoplasma pneumoniae, Legionella pneumophila, and Chlamydia pneumoniae). In LEAP-1, participants received intravenous lefamulin 150 mg every 12 h for 5-7 days or moxifloxacin 400 mg every 24 h for 7 days, with optional intravenous-to-oral switch. In LEAP-2, participants received oral lefamulin 600 mg every 12 h for 5 days or moxifloxacin 400 mg every 24 h for 7 days. Primary outcomes were early clinical response at 96 ± 24 h after first dose and investigator assessment of clinical response at test of cure (5-10 days after last dose). Atypical pathogens were identified in 25.0% (91/364) of lefamulin-treated patients and 25.2% (87/345) of moxifloxacin-treated patients; most were identified by ≥1 standard diagnostic modality (M. pneumoniae 71.2% [52/73]; L.pneumophila 96.9% [63/65]; C. pneumoniae 79.3% [46/58]); the most common standard diagnostic modality was serology. In terms of disease severity, more than 90% of patients had CURB-65 (confusion of new onset, blood urea nitrogen > 19 mg/dL, respiratory rate ≥ 30 breaths/min, blood pressure
Document Type: article in journal/newspaper
File Description: application/pdf
Language: unknown
Relation: qt6h23c96c; https://escholarship.org/uc/item/6h23c96c; https://escholarship.org/content/qt6h23c96c/qt6h23c96c.pdf
DOI: 10.3390/antibiotics10121489
Availability: https://escholarship.org/uc/item/6h23c96c; https://escholarship.org/content/qt6h23c96c/qt6h23c96c.pdf; https://doi.org/10.3390/antibiotics10121489
Rights: CC-BY
Accession Number: edsbas.29B07D0E
Database: BASE