Dataset Information

665. In vitro Activity of Omadacycline Against Recent (2018) Bacterial Pathogens from the United States and Europe Obtained from Skin and Skin Structure, Respiratory, and Urinary Tract Infections

ABSTRACT: Abstract Background Omadacycline (OMC) was FDA approved to treat acute bacterial skin and skin structure infection (ABSSSI) and community-acquired bacterial pneumonia (CABP) for indicated organisms in 2018. Phase 2 OMC clinical trials for uncomplicated urinary tract infection (uUTI; NCT03425396) and acute pyelonephritis (NCT03757234) are ongoing. OMC is active against bacterial isolates expressing common tetracycline, penicillin, fluoroquinolone, and macrolide resistance mechanisms. Methods Isolates (14,000) were collected in 2018 from 31 medical centers located in the United States and 38 medical centers in Europe, including 3,458 staphylococci, 1,551 streptococci, 746 enterococci, 574 Haemophilus spp., and 5,690 Enterobacterales isolates. One isolate per patient infection episode was tested. Identifications were confirmed by MALDI-TOF MS and susceptibility testing was performed using CLSI broth microdilution methods. Results OMC (MIC50/90, 0.12/0.25 mg/L) was highly active against S. aureus isolates from skin and skin structure infection (SSSI; 99.3% susceptible [S]) including MRSA (97.7%S) and MSSA (99.9%S) (table). Similarly, OMC demonstrated potent activity against S. aureus isolates from respiratory tract infection (RTI; MIC50/90, 0.12/0.25 mg/L) including MSSA (98.2%S). All S. lugdunensis isolates from SSSI were S (100.0%) to OMC. All Streptococcus anginosus group (100.0%) and 97.6% of S. pyogenes isolates from SSSI were S to OMC as were 98.0% of S. pneumoniae from RTI. No streptococci were resistant (R) to OMC. OMC (MIC50/90 0.12/0.25 mg/L) had potent activity against E. faecalis isolates from SSSI (99.0%S). OMC S against E. cloacae and K. pneumoniae isolates from SSSI was 92.1% S and 89.4% S, respectively. Similarly, 86.2% of K. pneumoniae isolates from RTI were S to OMC. Susceptibility of H. influenzae isolates from RTI to OMC was 99.8%S (no isolates were R). ?90.0% of E. coli (MIC50/90, 1/2 mg/L) and K. pneumoniae (MIC50/90, 2/4 mg/L) UTI isolates were inhibited by ?4 mg/L of OMC. Conclusion OMC was highly active against bacterial pathogens associated with ABSSSI, CABP, and UTI including staphylococci (97.7%-100.0%S), streptococci (97.6%-100.0%S), E. faecalis (99.0%S). E. cloacae (92.1%S), K. pneumoniae (86.2%-89.4%S), and E. coli. Disclosures All authors: No reported disclosures.

SUBMITTER: Huband M

PROVIDER: S-EPMC6811136 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Omadacycline is a broad-spectrum aminomethylcycline approved in October 2018 by the U.S. Food and Drug Administration for treating acute bacterial skin and skin structure infections and community-acquired pneumonia as both an oral and intravenous once-daily formulation. In this report, the activities of omadacycline and comparators were tested against 49,000 nonduplicate bacterial isolates collected prospectively during 2016 to 2018 from medical centers in Europe (24,500 isolates, 40 medical centers [19 countries]) and the United States (24,500 isolates, 33 medical centers [23 states and all 9 U.S. census divisions]). Omadacycline was tested by broth microdilution following the methods in Clinical and Laboratory Standards Institute document M07 (Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard, 11th ed., 2018). Omadacycline (MIC50/90, 0.12/0.25?mg/liter) inhibited 98.6% of Staphylococcus aureus isolates at ?0.5?mg/liter, including 96.3% of methicillin-resistant S. aureus isolates and 99.8% of methicillin-susceptible S. aureus isolates. Omadacycline potency was comparable for Streptococcus pneumoniae (MIC50/90, 0.06/0.12?mg/liter), viridans group streptococci (MIC50/90, 0.06/0.12?mg/liter), and beta-hemolytic streptococci (MIC50/90, 0.12/0.25?mg/liter), regardless of species and susceptibility to penicillin, macrolides, or tetracycline. Omadacycline was active against all Enterobacterales tested (MIC50/90, 1/8?mg/liter; 87.5% of isolates were inhibited at ?4?mg/liter) except Proteus mirabilis (MIC50/90, 16/>32?mg/liter) and indole-positive Proteus spp. (MIC50/90, 8/32?mg/liter) and was most active against Escherichia coli (MIC50/90, 0.5/2?mg/liter), Klebsiella oxytoca (MIC50/90, 1/2?mg/liter), and Citrobacter spp. (MIC50/90, 1/4?mg/liter). Omadacycline inhibited 92.4% of Enterobacter cloacae species complex and 88.5% of Klebsiella pneumoniae isolates at ?4?mg/liter. Omadacycline was active against Haemophilus influenzae (MIC50/90, 0.5/1?mg/liter), regardless of ?-lactamase status, and against Moraxella catarrhalis (MIC50/90, ?0.12/0.25?mg/liter). The potent activity of omadacycline against Gram-positive and -negative bacteria indicates that omadacycline merits further study in serious infections in which multidrug resistance and mixed Gram-positive and Gram-negative bacterial infections may be a concern.

Project description:INTRODUCTION:Concerns regarding the quality, credibility, and applicability of recently published pediatric urinary tract infection (UTI) clinical practice guidelines have been raised due to the inconsistencies of recommendations between them. We aimed to determine the quality of the recent clinical practice guidelines on pediatric UTI by using the Appraisal of Guidelines Research and Evaluation (AGREE II) instrument, and summarize the standard of care in diagnosis and management of pediatric UTI from the top three clinical practice guidelines. METHODS:A systematic literature search was performed on medical literature electronic databases and international guideline repository websites. English language-based clinical practice guidelines from 2007-2016 endorsed by any international society or government organization providing recommendations for the management of pediatric UTI were considered. Eligible clinical practice guidelines were independently appraised by six reviewers using the AGREE II tool. Clinical practice guidelines were assessed for standardized domains and summarized for overall quality. Inter-rater reliability was assessed using inter-class coefficient (ICC). RESULTS:Thirteen clinical practice guidelines were critically reviewed. The Spanish clinical practice guidelines, American Academy of Pediatrics, and National Institute for Health and Clinical Excellence clinical practice guidelines consistently scored high on all AGREE domains (total averaged domain scores 90, 88, and 88, respectively). Among the six reviewers, there was a high degree of inter-rater reliability (average measure ICC 0.938; p<0.0001). There is reasonable consensus among the top three clinical practice guidelines in their major recommendations. CONCLUSIONS:The clinical practice guidelines from Spain, American Academy of Pediatrics, and National Institute for Health and Clinical Excellence, with their major recommendations being similar, have scored highly on the AGREE II indicators of quality for the clinical practice guidelines development process.

Dataset Information

665. In vitro Activity of Omadacycline Against Recent (2018) Bacterial Pathogens from the United States and Europe Obtained from Skin and Skin Structure, Respiratory, and Urinary Tract Infections

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets