Universität zu Köln

Cornely, Oliver A., File, Thomas M., Jr., Garrity-Ryan, Lynne, Chitra, Surya ORCID: 0000-0002-5682-9200, Noble, Robert and McGovern, Paul C. (2021). Safety and efficacy of omadacycline for treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in patients with mild-to-moderate renal impairment. Int. J. Antimicrob. Agents, 57 (2). AMSTERDAM: ELSEVIER. ISSN 1872-7913

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Abstract

Background: Many antibiotics require dosage adjustments in patients with renal impairment. In Phase III studies, omadacycline was non-inferior to moxifloxacin and linezolid in adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), respectively. This analysis evaluated efficacy and safety measures from three omadacycline studies by patient renal function. Methods: Patients were stratified as having normal renal function (creatinine clearance 89 mL/min), mild renal impairment (creatinine clearance 60-89 mL/min) or moderate renal impairment (creatinine clearance < 60 mL/min); creatine clearance <= 30 mL/min (severe renal impairment) was an exclusion criterion. Efficacy endpoints were clinical success at the early clinical response (ECR) and post-treatment evaluation (PTE) time-points. Safety was evaluated as treatment-emergent adverse events (TEAEs) and laboratory measures. Results: This subgroup analysis included 773 patients with CABP and 1339 patients with ABSSSI in intent to-treat (ITT) and modified ITT populations, respectively. Clinical success rates were high at ECR and PTE across the studies (CABP 75-90%; ABSSSI 74-95%), and broadly similar between treatments, irrespective of renal function. Rates of TEAEs in patients with ABSSSI ranged from 33% to 52%, and were similar across renal function groups. In patients with CABP, higher rates were observed in patients with moderate renal impairment (56-61%) compared with patients with normal renal function or mild renal impairment (35- 49%). The most common TEAEs were nausea and vomiting. Conclusions: Clinical success was similar across renal function groups, indicating no notable difference in the efficacy of omadacycline in patients with mild or moderate renal impairment. Omadacycline and comparators displayed similar safety profiles. (C) 2020 The Authors. Published by Elsevier Ltd.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Cornely, Oliver A. UNSPECIFIED UNSPECIFIED UNSPECIFIED File, Thomas M., Jr. UNSPECIFIED UNSPECIFIED UNSPECIFIED Garrity-Ryan, Lynne UNSPECIFIED UNSPECIFIED UNSPECIFIED Chitra, Surya UNSPECIFIED orcid.org/0000-0002-5682-9200 UNSPECIFIED Noble, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED McGovern, Paul C. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-585997
DOI:	10.1016/j.ijantimicag.2020.106263
Journal or Publication Title:	Int. J. Antimicrob. Agents
Volume:	57
Number:	2
Date:	2021
Publisher:	ELSEVIER
Place of Publication:	AMSTERDAM
ISSN:	1872-7913
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Infectious Diseases; Microbiology; Pharmacology & Pharmacy Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/58599