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1422. A Multi-Center Evaluation of Omadacycline for Multi-Drug Resistant Infections

BACKGROUND: Multi-drug resistant (MDR) pathogens are a continuously evolving threat for which there are limited effective treatment modalities. Omadacycline (OMC) is a novel oral and intravenously administered aminomethylcycline with potent in-vitro activity against MDR gram-negative and gram-positi...

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Autores principales: Ghali, Amer El, Allosaimy, Sara, Morrisette, Taylor, Molina, Kyle C, Frens, Jeremy J, Stevens, Ryan W, Bouchard, Jeannette, Brandon Bookstaver, P, Veve, Michael P, Vemula, Raaga, Philley, Julie, Rebold, Nicholas S, Holger, Dana, Kunz Coyne, Ashlan J, Lagnf, Abdalhamid M, Lucas, Kristen, Witucki, Paige, Rybak, Michael J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9752563/
http://dx.doi.org/10.1093/ofid/ofac492.1251
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author Ghali, Amer El
Ghali, Amer El
Allosaimy, Sara
Morrisette, Taylor
Molina, Kyle C
Frens, Jeremy J
Stevens, Ryan W
Bouchard, Jeannette
Brandon Bookstaver, P
Veve, Michael P
Vemula, Raaga
Philley, Julie
Rebold, Nicholas S
Holger, Dana
Kunz Coyne, Ashlan J
Lagnf, Abdalhamid M
Lucas, Kristen
Witucki, Paige
Rybak, Michael J
author_facet Ghali, Amer El
Ghali, Amer El
Allosaimy, Sara
Morrisette, Taylor
Molina, Kyle C
Frens, Jeremy J
Stevens, Ryan W
Bouchard, Jeannette
Brandon Bookstaver, P
Veve, Michael P
Vemula, Raaga
Philley, Julie
Rebold, Nicholas S
Holger, Dana
Kunz Coyne, Ashlan J
Lagnf, Abdalhamid M
Lucas, Kristen
Witucki, Paige
Rybak, Michael J
author_sort Ghali, Amer El
collection PubMed
description BACKGROUND: Multi-drug resistant (MDR) pathogens are a continuously evolving threat for which there are limited effective treatment modalities. Omadacycline (OMC) is a novel oral and intravenously administered aminomethylcycline with potent in-vitro activity against MDR gram-negative and gram-positive pathogens. Post-marketing data investigating its potential place in the antibiotic armamentarium is limited. This study aimed at describing the clinical success and tolerability of patients receiving OMC for various infections. METHODS: This was a multicenter, retrospective, observational study conducted from January 2020 to March 30, 2022. We included all patients ≥ 18 years of age that received OMC for any infection not related to Mycobacterium spp. for ≥72 hours. The primary outcome was clinical success at 30 days, defined as survival, the absence of persistence or re-emergence of infection during or after therapy, and the absence of escalation or alteration of OMC. Incidence of adverse effects while on OMC and reasons for OMC utilization were also analyzed. RESULTS: This analysis included 19 patients from 10 distinct academic centers. The median age was 50 years (IQR, 37-63), 58% were male, 63% were Caucasian, and the median APACHE II, Charlson and SOFA scores were 10 (IQR 5-12.5), 4 (IQR 2-6.3), and 1 (IQR 0 – 2.25), respectively. Most patients had a bone and joint (8/19, 42.1%) or intra-abdominal infections (4/19, 21.1%), all with positive cultures. Eight patients (44.1%) had a polymicrobial infection and 4 (22.2%) had bacteremia. The most common pathogens encountered were Carbapenem-resistant A. baumannii (5/19, 27.8%), E. coli (5/19, 27.8%), Vancomycin-resistant Enterococcus spp. (4/19, 22.2%), and K. pneumoniae (3/19, 16.7%). Clinical success was observed in 14 patients (74%) and 7 (36.8%) received combination therapy. Adverse drug reactions were reported in 3 patients (15.8%) and of those patients, none discontinued therapy. Reasons for prescribing OMC were mostly attributed to oral availability (12/14, 85.7%) and resistance to other agents (7/14, 50%). CONCLUSION: OMC demonstrated clinical effectiveness and safety against a large number of MDR pathogens. More robust, prospective, comparative studies are needed to confirm our preliminary findings. DISCLOSURES: P. Brandon Bookstaver, PharmD, Spero Therapeutics: Advisor/Consultant.
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spelling pubmed-97525632022-12-16 1422. A Multi-Center Evaluation of Omadacycline for Multi-Drug Resistant Infections Ghali, Amer El Ghali, Amer El Allosaimy, Sara Morrisette, Taylor Molina, Kyle C Frens, Jeremy J Stevens, Ryan W Bouchard, Jeannette Brandon Bookstaver, P Veve, Michael P Vemula, Raaga Philley, Julie Rebold, Nicholas S Holger, Dana Kunz Coyne, Ashlan J Lagnf, Abdalhamid M Lucas, Kristen Witucki, Paige Rybak, Michael J Open Forum Infect Dis Abstracts BACKGROUND: Multi-drug resistant (MDR) pathogens are a continuously evolving threat for which there are limited effective treatment modalities. Omadacycline (OMC) is a novel oral and intravenously administered aminomethylcycline with potent in-vitro activity against MDR gram-negative and gram-positive pathogens. Post-marketing data investigating its potential place in the antibiotic armamentarium is limited. This study aimed at describing the clinical success and tolerability of patients receiving OMC for various infections. METHODS: This was a multicenter, retrospective, observational study conducted from January 2020 to March 30, 2022. We included all patients ≥ 18 years of age that received OMC for any infection not related to Mycobacterium spp. for ≥72 hours. The primary outcome was clinical success at 30 days, defined as survival, the absence of persistence or re-emergence of infection during or after therapy, and the absence of escalation or alteration of OMC. Incidence of adverse effects while on OMC and reasons for OMC utilization were also analyzed. RESULTS: This analysis included 19 patients from 10 distinct academic centers. The median age was 50 years (IQR, 37-63), 58% were male, 63% were Caucasian, and the median APACHE II, Charlson and SOFA scores were 10 (IQR 5-12.5), 4 (IQR 2-6.3), and 1 (IQR 0 – 2.25), respectively. Most patients had a bone and joint (8/19, 42.1%) or intra-abdominal infections (4/19, 21.1%), all with positive cultures. Eight patients (44.1%) had a polymicrobial infection and 4 (22.2%) had bacteremia. The most common pathogens encountered were Carbapenem-resistant A. baumannii (5/19, 27.8%), E. coli (5/19, 27.8%), Vancomycin-resistant Enterococcus spp. (4/19, 22.2%), and K. pneumoniae (3/19, 16.7%). Clinical success was observed in 14 patients (74%) and 7 (36.8%) received combination therapy. Adverse drug reactions were reported in 3 patients (15.8%) and of those patients, none discontinued therapy. Reasons for prescribing OMC were mostly attributed to oral availability (12/14, 85.7%) and resistance to other agents (7/14, 50%). CONCLUSION: OMC demonstrated clinical effectiveness and safety against a large number of MDR pathogens. More robust, prospective, comparative studies are needed to confirm our preliminary findings. DISCLOSURES: P. Brandon Bookstaver, PharmD, Spero Therapeutics: Advisor/Consultant. Oxford University Press 2022-12-15 /pmc/articles/PMC9752563/ http://dx.doi.org/10.1093/ofid/ofac492.1251 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Abstracts
Ghali, Amer El
Ghali, Amer El
Allosaimy, Sara
Morrisette, Taylor
Molina, Kyle C
Frens, Jeremy J
Stevens, Ryan W
Bouchard, Jeannette
Brandon Bookstaver, P
Veve, Michael P
Vemula, Raaga
Philley, Julie
Rebold, Nicholas S
Holger, Dana
Kunz Coyne, Ashlan J
Lagnf, Abdalhamid M
Lucas, Kristen
Witucki, Paige
Rybak, Michael J
1422. A Multi-Center Evaluation of Omadacycline for Multi-Drug Resistant Infections
title 1422. A Multi-Center Evaluation of Omadacycline for Multi-Drug Resistant Infections
title_full 1422. A Multi-Center Evaluation of Omadacycline for Multi-Drug Resistant Infections
title_fullStr 1422. A Multi-Center Evaluation of Omadacycline for Multi-Drug Resistant Infections
title_full_unstemmed 1422. A Multi-Center Evaluation of Omadacycline for Multi-Drug Resistant Infections
title_short 1422. A Multi-Center Evaluation of Omadacycline for Multi-Drug Resistant Infections
title_sort 1422. a multi-center evaluation of omadacycline for multi-drug resistant infections
topic Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9752563/
http://dx.doi.org/10.1093/ofid/ofac492.1251
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