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Surveillance Programs

 

Datasets from the following AMR surveillance programs are available to request via the Vivli AMR Register.

Pharmaceutical industry AMR surveillance programs are conducted to fulfill regulatory requirements for antimicrobials in development and also as post approval commitments to monitor susceptibility and resistance for marketed antimicrobials.

Programs are usually global in scope and conducted via experienced vendors within three years of expected filing and continued post approval to monitor changes in resistance patterns and trends at a global, regional and local level and to provide healthcare practitioners with susceptibility data to support the appropriate use of antimicrobials.

Programs

GSK – SOAR 201818

SOAR 201818 Program
Conducted by GSK
Active: 2014-2016

Countries: Romania, Bulgaria, Croatia, Serbia, Ukraine, Slovak Republic, Russia, Czech Republic, Greece

Primary objective
Data generation for antibiotic resistance of the main community-acquired respiratory tract infection pathogens such as S.pneumoniae and H.influenzae.

Protocol Summary

Isolates collection method:Local labs identify microorganisms based on their routinely used methodology. Then isolates are identified at third party's central laboratory to re-identify microorganisms and perform antibiotic susceptibility testing.
Types of surveillance:Primarily for routine clinical practice, then used for surveillance.
Methodology and breakpoints:Broth microdilution according to CLSI guidelines.
Date Last Updated31-Dec-2016
Contains pediatric data?Yes
Contains genotype data?No
List of publications to be linked Survey of Antibiotic Resistance (SOAR) results 2: respiratory pathogen susceptibility: doi.org/10.1093/jac/dky080
Results from the Survey of Antibiotic Resistance (SOAR) 2014–16 in Bulgaria, Romania, Serbia and Croatia: doi.org/10.1093/jac/dky066
Results from the Survey of Antibiotic Resistance (SOAR) 2014–16 in Russia: doi.org/10.1093/jac/dky065
Results from the Survey of Antibiotic Resistance (SOAR) 2014–16 in the Czech Republic: doi.org/10.1093/jac/dky067
Results from the Survey of Antibiotic Resistance (SOAR) 2014–16 in Ukraine and the Slovak Republic: doi.org/10.1093/jac/dky069
Results from the Survey of Antibiotic Resistance (SOAR) 2014–16 in Greece: doi.org/10.1093/jac/dky068

Johnson & Johnson – Bedaquiline Drug Resistance Assessment in MDR-TB (DREAM)

Bedaquiline Drug Resistance Assessment in MDR-TB (DREAM)
Conducted by Johnson & Johnson Family of Companies

Countries: India, Lithuania, Pakistan, Philippines, South Africa, South Korea, Taiwan, Thailand, Turkey, USA, Viet Nam

Primary objective
To determine the level of susceptibility of MDR-TB isolates to BDQ by the minimal inhibitory concentration (MIC) drug susceptibility testing (DST) methods.

 

Protocol SummaryDREAM program to determine the level of susceptibility of multidrug-resistant tuberculosis isolates to bedaquiline. Preliminary identification and rapid DST are performed at the local labs. Pure cultures are sent to the NTRL for additional phenotypic DST.
Isolates must be or must have been collected from MDR-TB patients. In some cases, resistance to rifampicin is sufficient. Non-mycobacteria, non-tuberculosis mycobacteria and rifampicin susceptible MTB are excluded.
Currently there are no FDA/CLSI breakpoints for BDQ. EUCAST had established a provisional susceptible breakpoint of ≤0.25 mg/L irrespective of the test medium. Given that the EUCAST breakpoint was based on limited data available at the time, we are defining new interpretive criteria based on ECV/ECOFF from the data generated. These in turn are used to interpret the surveillance results.
Isolates collection method:A mix of prospective and retrospective isolates are collected locally and submitted to the National TB Reference Laboratory (NTRL).
Types of surveillance:Isolates are collected primarily for routine clinical practice, then used for surveillance.
Number of Isolates5,036
Contains pediatric data?N/A
Contains genotype data?No
Date Last Updated31-July-2019 (last isolate collected)
Expected frequency of updates to the datasetNone
List of publications to be linked J Clin Microbiol 60:e02919-20. doi.org/10.1128/JCM.02919-20
Supporting documents to be provided
Any additional information

Merck – SMART Surveillance

SMART Surveillance
Conducted by Merck

Access Information:

To access Merck’s SMART Surveillance program, submit a request for the SMART datasets to be redirected to the appropriate Merck website:

  • SMART Surveillance Heatmaps
  • SMART Surveillance data request

Primary objective
Global surveillance; resistance trend analysis; fulfilment of regulatory commitments.

 

Protocol SummarySpecimens are collected, as per hospital protocol, from patients suspected with having an infectious disease and sent to the microbiology lab for identification, and susceptibility testing, of the suspected pathogen.
Each site enrolled in SMART collects 50 clinical gram-negative (GN) isolates from IAI, UTI and BSI; 100 GN isolates from RTI. Only the first isolate per patient is collected.
The isolates are sent to the SMART surveillance program central lab (IHMA) for confirmation of identification and susceptibility testing.
Participating labs indicate on form whether isolate was collected =48h after admission. In addition age and hospital location is indicated.
Subsequently, isolates that conform to a molecular algorithm are tested for mechanisms of resistance.
Number of Isolates300,000+
Contains pediatric data?Yes
Contains genotype data?Yes
Date Last UpdatedThru Dec-2020
Expected frequency of updates to the datasetAnnually
Publications Register and log in at globalsmartsite.com then navigate to Resources and Publications globalsmartsite.com/#/resources/publications

Paratek – KEYSTONE

KEYSTONE Program
Conducted by Paratek
Active: 2014-2020

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 TitleOmadacycline Activity Against Clinical Isolates Collected from the United States and Europe during 2014-2020
Protocol SummaryOmadacycline 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 60,000 Gram-positive and Gram-negative isolates collected during 2014-2020 from United States and Europe.
Isolates collection methodBacterial 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 surveillanceRoutine clinical practice then used for surveillance
Dataset FormatExcel
Number of Isolates69,209
Contains pediatric data?No
Contains genotype data?No
Date Last Updated31-Dec-2020
Expected frequency of updates to the datasetAnnually
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 providedhttps://paratek-keystone.com/

Pfizer – ATLAS

ATLAS (Antimicrobial Testing Leadership and Surveillance) Program
Conducted by Pfizer
Active: 2004 Onwards

Countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Ivory Coast, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United States, Venezuela, Vietnam

Primary objective
The ATLAS programme monitors changes in antibiotic susceptibility, bacterial resistance trends and emergence of new resistance mechanism for both marketed and in development antibiotics.  In addition, provides genotypic information when tested.  The SENTRY platform data allow for monitoring of antifungal susceptibility and resistance trending of key antifungals.

 

Protocol SummaryThe ATLAS program is one overall study (formerly TEST, INFORM and AWARE) fulfilling regulatory requirements and supporting appropriate use measures for both marketed antibiotics (Tygacil, Zyvox, Zosyn/Tazocin, Zavicefta, Zinforo, Merrem and others) by monitoring changes in antibiotic susceptibility, bacterial resistance trends and emergence of new resistance mechanisms. CLSI breakpoints are utilized but the option exists to analyse the data by using EUCAST breakpoints. All bacterial isolate identifications and susceptibility profiles are performed by standardized broth microdilution methods by a central lab. The antifungal data from the SENTRY platform are generated by standardized antifungal susceptibility methods performed at a central laboratory.
Isolates collection method:Actively collected from local labs and sent to central laboratory for identification and susceptibility testing.
Types of surveillance:Isolates are collected specifically for surveillance.
Methodology and breakpoints:CLSI breakpoints are utilized but the option exists to analyse the data by using EUCAST breakpoints.
Number of Isolates>790,000
Contains pediatric data?Yes
Contains genotype data?Yes
Date Last UpdatedDecember 2021
Expected frequency of updates to the datasetAnnually
List of publications to be linked Can be found at www.atlas-surveillance.com on the resources tab.

Published poster with some details on the protocol: www.ihma.com/app/uploads/Pfizer_P107_ATLAS-Overview_IDWeek-2020_FINAL.pdf
Any additional informationThe ATLAS database is updated every 9 to 12 months with emerging data from across 80 countries. Data for compounds in development are not made available via the public website but are available via publications and medical requests for information. Year in and year out integrated, with search by individual year possible as well. Database system built by Micron Research, UK.

Shionogi – SIDERO-WT

SIDERO-WT Program
Conducted by Shionogi
Active: 2014-2019

Countries Canada, Czech Republic, France, Germany, Greece, Hungary, Italy, Russia, Spain, Sweden, Turkey, UK, USA

Primary objective
Annual evaluation of cefiderocol activities against US/EU Gram-negative isolates. To evaluate the antibacterial activity of cefiderocol and comparators against a wide variety of Gram-negative bacteria including carbapenem-resistant isolates.

 

Protocol SummarySIDERO-WT, antibiotic susceptibility surveillance data for each isolate from North America and Europe in 2014 to 2019. In five consecutive annual SIDERO-WT surveillance studies (2014 to 2019), the susceptibility of cefiderocol and comparators against Gram-negative clinical isolates from North America and Europe was evaluated by broth microdilution. MICs of cefiderocol have been determined by broth microdilution assay using iron-depleted cation-adjusted Mueller-Hinton broth, which has been approved by CLSI and EUCAST. MICs of other comparators have been determined by broth microdilution assay using cation-adjusted Mueller-Hinton broth, which has been approved by CLSI and EUCAST. The breakpoints of comparators were based on published information by CLSI and EUCAST.
47615 isolates (including 31,896 isolates of Enterobacterales, 7,700 isolates of Pseudomonas aeruginosa, 5,225 isolates of Acinetobacter baumannii complex, 2,030 isolates of Stenotrophomonas maltophilia, and 425 isolates of Burkholderia cepacia complex).
Isolates collection methodPredefined quotas of isolates of specific Gram-negative bacilli cultured from patients with intra-abdominal, urinary tract, lower respiratory tract, skin and soft tissue, or bloodstream infections were collected from clinical laboratories in North America and Europe from November 2014 to December 2019.

For methods: http://aac.asm.org/content/61/9/e00093-17.full.pdf+html?sid=d0d5821d-867f-48f9-8037-4e6cc05ab717. For QC ranges: http://www.dmidjournal.com/article/S0732-8893(17)30105-0/abstract
Types of surveillanceRoutine clinical practice then used for surveillance.
Number of Isolates47615
Contains pediatric data?No
Contains genotype data?No
Date Last Updated31-Dec-2019
Expected frequency of updates to the datasetSIDERO-WT completed in 2019, other surveillance studies (SENTRY by JMI) started from 2020, which is available on JMI SENTRY website https://mvp.jmilabs.com/
Dataset FormatExcel
List of publications to be linked https://doi.org/10.1128/AAC.01990-21
https://doi.org/10.1016/j.ijantimicag.2018.11.007
https://doi.org/10.1128/AAC.00093-17
Any additional informationMIC concentration abbreviations: 0.0019=≤0.002, 0.0299 = ≤0.03, 0.0599= ≤0.06, 0.1199= ≤0.12,0.2499= ≤0.25, 1.999= ≤2, 4.0001= >4, 8.0001= >8, 16.0001= >16, 32.0001= >32, 64.0001=>64, 256.0001=>256
Annual data is published as separate studies. New surveillance data is not integrated with the previous surveillance data.

Venatorx – Global surveillance 2018-2020

Global surveillance 2018-2020
Conducted by Venatorx
Active: 2018-2020

Countries: Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Panama, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Venezuela, Vietnam

Primary Objective
To determine AMR rates in key gram-negative pathogens from global sites

 

Protocol SummaryStudy organisms were clinical isolates previously collected and frozen at -70°C. Isolates were from documented infections (clinically relevant causative agent), with only one isolate per species per patient allowed. Isolates were from community- and hospital-associated infection sources, distributed globally (>250 sites; >50 countries) with a focus on the United States (for 2018-2020: 22.4% of total) and Europe (for 2018-2020: 42.1% of total). Patient locations included: General Medicine; Medical ICU; Surgery General; Surgery ICU; Emergency Room; Pediatric ICU; General ICU; and Pediatric General. Isolates were sourced from: respiratory tract infections, urinary tract infections, bloodstream infections, intraabdominal infections, and skin/soft tissue infections. Organisms included Enterobacterales (for 2018-2020: n=13,731), Pseudomonas aeruginosa (for 2018-2020: n=4,619), Stenotrophomonas maltophilia (for 2018-2020: n=298) and methicillin-susceptible Staphylococcus aureus (for 2018-2020: MSSA; n=140). The identities of all isolates were confirmed using MALDI-TOF mass spectrometry. Broth microdilution MICs were determined using the ISO 20776-1:2019/CLSI M07 11th Ed. reference method. Quality control (QC) testing was performed each day of testing (CLSI M100).

Inclusions: human infection (clinically relevant causative agent), one isolate per infection episode; Exclusions: screening/carriage isolates, multiple isolates per infection episode.
Isolates collection methodClinically relevant causative agent only; one isolate per infection episode.
Types of surveillancePrevalence-based
Dataset FormatExcel
Number of Isolates18,788
Contains pediatric data?Yes
Contains genotype data?No
Date Last Updated31-Dec-2020
Expected frequency of updates to the datasetTo be determined
PublicationsLink to (surveillance) posters on Venatorx corporate website provided here: www.venatorx.com