KEYSTONE Program
Conducted by Paratek
Active: 2014-2022
Countries: Austria, Belarus, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey, UK, Ukraine, USA
Primary Objective
The Keystone Surveillance Program was designed to monitor omadacycline susceptibility over time while fulfilling post-marketing regulatory requirements. Providing access to current antimicrobial susceptibility data including omadacycline, will play an essential role in monitoring the prevalence of antimicrobial resistance globally.
| Dataset Title | Omadacycline Activity Against Clinical Isolates Collected from the United States and Europe during 2014-2023 |
| Protocol Summary | Omadacycline is a broad-spectrum tetracycline-class antibacterial agent specifically designed to overcome tetracycline resistance mechanisms such as efflux pumps and ribosomal protection. Omadacycline received Food and Drug Administration (FDA) approval for oral and intravenous formulations for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia (CABP) in October 2018. Omadacycline is active against difficult-to-treat pathogens, such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), penicillin- and macrolide-resistant pneumococci, and Enterobacterales isolates that produce an array of extended-spectrum β-lactamases (ESBLs). The KEYSTONE Surveillance Program evaluated the in vitro antimicrobial activity of omadacycline and comparator agents against over 83,000 Gram-positive and Gram-negative isolates collected during 2014-2023 from United States and Europe. |
| Isolates collection method | Bacterial isolates are consecutively collected from sites in United States and Europe (1 isolate per patient infection episode) according to the infection type and sent to JMI Laboratories, North Liberty, Iowa, USA for susceptibility testing by reference broth microdilution methods per CLSI guidelines against most antimicrobial agents currently utilized to treat Gram-positive and Gram-negative infections. |
| Types of surveillance | Routine clinical practice then used for surveillance |
| Dataset Format | Excel |
| Number of Isolates | 90,208 |
| Contains pediatric data? | Yes |
| Contains genotype data? | No |
| Date Last Updated | 13-June-2024 |
| Expected frequency of updates to the dataset | Annually |
| List of publications to be linked | https://pubmed.ncbi.nlm.nih.gov/34775129/ https://www.jmilabs.com/data/posters/19-PAR-12_P2_FinaltoJMI_0925.pdf https://pubmed.ncbi.nlm.nih.gov/32071045/ https://www.jmilabs.com/data/posters/IDWeek2019_Omadacycline_Final.pdf https://pubmed.ncbi.nlm.nih.gov/30825698/ https://pubmed.ncbi.nlm.nih.gov/29378719/ |
| Supporting documents to be provided | https://paratek-keystone.com/ |