Real-World, Multicenter Case Series of Patients Treated with Oral Omadacycline for Resistant Gram-Negative Pathogens

Taylor Morrisette^{1

2

3}, Sara Alosaimy¹, Abdalhamid M Lagnf¹, Jeremy J Frens⁴, Andrew J Webb⁵, Michael P Veve^{6

7

8}, Ryan Stevens⁵, Jeannette Bouchard⁹, Tristan W Gore⁹, Iman Ansari¹, Michael J Rybak^{10

11

12}

Affiliations

¹ Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, 259 Mack Avenue, Detroit, MI, 48201, USA.
² Department of Clinical Pharmacy and Outcomes Sciences, Medical University of South Carolina College of Pharmacy, 280 Calhoun Street, Charleston, SC, 29425, USA.
³ Department of Clinical Pharmacy Services, Medical University of South Carolina Shawn Jenkins Children's Hospital, 10 McClennan Banks Drive, Charleston, SC, 29425, USA.
⁴ Department of Pharmacy, Cone Health, 1121 North Church Street, Greensboro, NC, 27401, USA.
⁵ Department of Pharmacy, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.
⁶ University of Tennessee Medical Center, 1924 Alcoa Hwy, Knoxville, TN, 37920, USA.
⁷ Department of Clinical Pharmacy and Transplational Science, College of Pharmacy, University of Tennessee Health Science Center, 1924 Alcoa Hwy, Knoxville, TN, 37920, USA.
⁸ Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, 259 Mack Avenue, Detroit, MI, 48206, USA.
⁹ College of Pharmacy, University of South Carolina, 715 Sumter Street, Columbia, SC, 29208, USA.
¹⁰ Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, 259 Mack Avenue, Detroit, MI, 48201, USA. m.rybak@wayne.edu.
¹¹ Division of Infectious Diseases, Department of Medicine, Wayne State University, 540 E Canfield Street, Detroit, MI, 48201, USA. m.rybak@wayne.edu.
¹² Department of Pharmacy, Detroit Receiving Hospital, 4201 St Antoine, Detroit, MI, 48201, USA. m.rybak@wayne.edu.

PMID: 35567718
PMCID: PMC9334473
DOI: 10.1007/s40121-022-00645-5

Real-World, Multicenter Case Series of Patients Treated with Oral Omadacycline for Resistant Gram-Negative Pathogens

Taylor Morrisette et al. Infect Dis Ther. 2022 Aug.

. 2022 Aug;11(4):1715-1723.

doi: 10.1007/s40121-022-00645-5. Epub 2022 May 14.

Authors

Affiliations

¹ Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, 259 Mack Avenue, Detroit, MI, 48201, USA.
² Department of Clinical Pharmacy and Outcomes Sciences, Medical University of South Carolina College of Pharmacy, 280 Calhoun Street, Charleston, SC, 29425, USA.
³ Department of Clinical Pharmacy Services, Medical University of South Carolina Shawn Jenkins Children's Hospital, 10 McClennan Banks Drive, Charleston, SC, 29425, USA.
⁴ Department of Pharmacy, Cone Health, 1121 North Church Street, Greensboro, NC, 27401, USA.
⁵ Department of Pharmacy, Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.
⁶ University of Tennessee Medical Center, 1924 Alcoa Hwy, Knoxville, TN, 37920, USA.
⁷ Department of Clinical Pharmacy and Transplational Science, College of Pharmacy, University of Tennessee Health Science Center, 1924 Alcoa Hwy, Knoxville, TN, 37920, USA.
⁸ Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, 259 Mack Avenue, Detroit, MI, 48206, USA.
⁹ College of Pharmacy, University of South Carolina, 715 Sumter Street, Columbia, SC, 29208, USA.
¹⁰ Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, 259 Mack Avenue, Detroit, MI, 48201, USA. m.rybak@wayne.edu.
¹¹ Division of Infectious Diseases, Department of Medicine, Wayne State University, 540 E Canfield Street, Detroit, MI, 48201, USA. m.rybak@wayne.edu.
¹² Department of Pharmacy, Detroit Receiving Hospital, 4201 St Antoine, Detroit, MI, 48201, USA. m.rybak@wayne.edu.

PMID: 35567718
PMCID: PMC9334473
DOI: 10.1007/s40121-022-00645-5

Abstract

Introduction: Antibiotic-resistant Gram-negative bacteria have been associated with substantial morbidity and mortality and have limited treatment options available. Omadacycline (OMC) is an aminomethylcycline antibiotic that has been shown to exhibit broad in vitro activity against antibiotic-resistant Gram-negative bacteria. Given the lack of real-world data, the primary objective of our report was to describe early experience with OMC for the treatment of resistant Gram-negative infections.

Methods: This was a real-world, multicenter, observational cases series/pilot study conducted in the USA. Inclusion criteria included any adult patient aged ≥ 18 years who received OMC for ≥ 72 h either in the inpatient and/or outpatient setting. Clinical success was defined as a composite of 90-day survival from initiation of OMC, lack of alteration in treatment/addition of other antibiotic due to concerns of OMC failure, and lack of microbiologic recurrence within 30 days from the end of therapy.

Results: Oral OMC was used in nine cases primarily for multidrug-resistant (MDR)/extensively drug-resistant (XDR) Gram-negative bacterial infections (55.6% XDR and/or carbapenem-resistant Acinetobacter baumannii [CRAB]). The majority of infections were of bone/joint (55.6%) origin, followed by intra-abdominal (33.3%) origin. Clinical success occurred in 66.7% of cases, with 80.0% success each in infections of bone/joint origin or those caused by CRAB. One patient experienced an adverse effect that was not treatment limiting while on therapy (gastrointestinal).

Conclusion: The use of oral OMC in MDR/XDR Gram-negative infections exhibited a relatively high success rate with minimal adverse effects. Real-world studies with larger case numbers are needed to confirm our initial findings.

Keywords: Carbapenem-resistant Acinetobacter baumannii; Carbapenem-resistant Enterobacteriaceae; Gram-negative resistance; Omadacycline.

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Real-World, Multicenter Case Series of Patients Treated with Oral Omadacycline for Resistant Gram-Negative Pathogens

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Real-World, Multicenter Case Series of Patients Treated with Oral Omadacycline for Resistant Gram-Negative Pathogens

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