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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: Susanne Paukner; David Mariano; Anita F. Das; Gregory J. Moran; Christian Sandrock; Ken B. Waites; Thomas M. File
Source: Antibiotics, Vol 10, Iss 1489, p 1489 (2021)
Publisher Information: MDPI AG
Publication Year: 2021
Collection: Directory of Open Access Journals: DOAJ Articles
Subject Terms: atypical pathogens; lefamulin; community-acquired bacterial pneumonia; Mycoplasma pneumoniae; Chlamydia pneumoniae; Legionella pneumophila; Therapeutics. Pharmacology; RM1-950
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
Language: English
Relation: https://www.mdpi.com/2079-6382/10/12/1489; https://doaj.org/toc/2079-6382; https://doaj.org/article/76c7e81345964cbda5fd2343e3fce190
DOI: 10.3390/antibiotics10121489
Availability: https://doi.org/10.3390/antibiotics10121489; https://doaj.org/article/76c7e81345964cbda5fd2343e3fce190
Accession Number: edsbas.152F1096
Database: BASE