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.
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 Updated | 31-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 |
SOAR 201910 Programme
Conducted by GSK
Active: 2015-2018
Countries: Argentina, Cambodia, Chile, Costa Rica, Kenya, Kuwait, Lebanon, Morocco, Pakistan, Philippines, Saudi Arabia, Singapore, Tunisia, Turkey, Ukraine, Vietnam
Primary objective
To determine antibiotic susceptibility of Streptococcus pneumoniae and Haemophilus influenzae isolates from community-acquired respiratory tract infections (CA-RTIs) collected during 2015–18
| Isolates collection method: | 2015-2018 surveillance study frozen stock culture collection. Isolates of S. pneumoniae and H. influenzae from CA-RTIs (patients with respiratory tract infections in the community, not hospitalized for more than 48h). MICs were determined by CLSI broth microdilution and susceptibility was assessed using CLSI, EUCAST (dose-specific) and pharmacokinetic/pharmacodynamic (PK/PD) breakpoints. Includes antibiotics: CDN-Ceftidoren, CEC-Cefaclor, CXM-Cefuroxime, DIN-Cefdinir, FIX-Cefixime |
| Types of surveillance: | Routine clinical practice then used for surveillance. |
| Methodology and breakpoints: | Broth microdilution according to CLSI guidelines. Reference- CLSI 32 Edition M100 -2022 |
| Date Last Updated | 31-Dec-2018 |
| Contains pediatric data? | Yes |
| Contains genotype data? | No |
| Number of isolates | 2318 |
| Publications | https://doi.org/10.1093/jac/dkaa081 https://doi.org/10.1093/jac/dkaa082 https://doi.org/10.1093/jac/dkaa083 https://doi.org/10.1093/jac/dkaa084 https://doi.org/10.1093/jac/dkaa085 https://doi.org/10.1093/jac/dkaa086 https://doi.org/10.1093/jac/dkaa087 |
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 Summary | DREAM 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 Isolates | 5,036 |
| Contains pediatric data? | N/A |
| Contains genotype data? | No |
| Date Last Updated | 31-July-2019 (last isolate collected) |
| Expected frequency of updates to the dataset | None |
| 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 |
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 Summary | Specimens 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 prior to admission to the hospital or >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 Isolates | 300,000+ |
| Contains pediatric data? | Yes |
| Contains genotype data? | Yes |
| Date Last Updated | Thru Dec-2020 |
| Expected frequency of updates to the dataset | Annually |
| Publications | Register and log in at globalsmartsite.com then navigate to Resources and Publications globalsmartsite.com/#/resources/publications |
KEYSTONE Program
Conducted by Paratek
Active: 2014-2023
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/ |
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, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Ivory Coast, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malawi, 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, Uganda, 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 Summary | The 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 | 917,049 antibiotic isolates, 21,631 antifungal isolates |
| Contains pediatric data? | Yes |
| Contains genotype data? | Yes |
| Date Last Updated | June 2024 |
| Expected frequency of updates to the dataset | Annually |
| 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 information | The ATLAS database is updated every 9 to 12 months with emerging data from across 83 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. |
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 Summary | SIDERO-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 method | Predefined 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 surveillance | Routine clinical practice then used for surveillance. |
| Number of Isolates | 47615 |
| Contains pediatric data? | No |
| Contains genotype data? | No |
| Date Last Updated | 31-Dec-2019 |
| Expected frequency of updates to the dataset | SIDERO-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 Format | Excel |
| 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 information | MIC 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. |
GEARS (Global Evaluation of Antimicrobial Resistance via Surveillance)
Conducted by Venatorx
Active: 2018-2022
Countries: Argentina, Australia, Belgium, Brazil, Cameroon, 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, Korea (Republic of), Kuwait, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, Ukraine, United Kingdom of Great Britain and Northern Ireland, United States of America, Venezuela (Bolivarian Republic of), Viet Nam
Primary Objective
To determine AMR rates in key gram-negative pathogens from global sites
| Protocol Summary | Study 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 with a focus on the United States and Europe. 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, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and methicillin-susceptible Staphylococcus aureus. 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 method | Clinically relevant causative agent only; one isolate per infection episode. |
| Types of surveillance | Prevalence-based |
| Dataset Format | Excel |
| Number of Isolates | 29,365 |
| Contains pediatric data? | Yes |
| Contains genotype data? | No |
| Date Last Updated | Jun-2024 |
| Expected frequency of updates to the dataset | Annually |
| Publications | Link to (surveillance) posters on Venatorx corporate website provided here: www.venatorx.com Publications: doi.org/10.1128/aac.01281-22 |
Preserving Life of Existing Antibiotics (PLEA) Study – I (2011 to 2016)
Conducted by Venus Remedies
Active: 2011-2016
Countries: India
Primary Objective
To examine the antimicrobial susceptibility profiles and resistance mechanisms of clinical isolates gathered from various periods and locations across India. This study focused on key gram-negative pathogens and their resistance patterns to inform and guide treatment strategies.
| Protocol Summary | The PLEA Surveillance Study I conducted from 2011 to 2016 collected 3,150 non-duplicate bacterial isolates from 22 medical centers across India. The study focused on four key gram-negative pathogens: Escherichia coli (716 isolates), Klebsiella pneumoniae (435 isolates), Pseudomonas aeruginosa (924 isolates), and Acinetobacter baumannii (1,075 isolates). To assess antimicrobial resistance, the study utilized CLSI-defined phenotypic methods for detecting ESBLs and MBLs. Genotypic characterization involved single PCR with a panel of primers to identify various beta-lactamase enzymes, including ESBLs (blaTEM, blaSHV, blaCTX-M), MBLs (blaVIM, blaNDM, blaIMP), carbapenemases (blaOXA, blaKPC), and Class C cephalosporinases (blaAmpC). MICs for multiple antibiotics, such as Meropenem, Imipenem-Cilastatin, and Colistin, was determined using the CLSI broth dilution method. |
| Isolate collection method | Systematically gathered from various hospital laboratories and forwarded to a central microbiology lab for identification and susceptibility testing. |
| Type of surveillance | Isolates were collected specifically for surveillance. |
| Methodology and Breakpoints: | Broth microdilution according to CLSI guidelines. |
| Contains pediatric data? | NA |
| Contains genotype data? | Yes |
| Number of isolates | 3150 |
| Date last updated | 22-12-2016 |
| Expected frequency of updates to the dataset | Study completed |
| Dataset format | Excel |
| Supporting documents to be provided | Protocol |
| Additional information | No |
| Publications | Girotra, Ruchi et al. “1373. Activity of Ceftriaxone–Sulbactam–EDTA Against Multi-Drug-resistant A. baumannii, P. aeruginosa and Enterobacteriaceae Isolates (WHO Critical Priority Pathogens) Collected from Various Hospitals in India.” Open Forum Infectious Diseases vol. 5,Suppl 1 S421. 26 Nov. 2018, doi: https://doi.org/10.1093/ofid/ofy210.1204 |
Preserving Life of Existing Antibiotics (PLEA) Study – II (2018 to 2020)
Conducted by Venus Remedies
Active: 2018-2020
Countries: India
Primary Objective
To examine the antimicrobial susceptibility profiles and resistance mechanisms of clinical isolates gathered from various periods and locations across India. This study focused on key gram-negative pathogens and their resistance patterns to inform and guide treatment strategies.
| Protocol Summary | The PLEA Surveillance Study II (2018-2020) involved the collection of 232 non-duplicate gram-negative clinical isolates from 15 medical centers in India between 2018 and 2020. The study focused on E. coli, Klebsiella spp., Acinetobacter spp., and Pseudomonas spp. MBL detection was performed using CLSI-defined phenotypic methods, while susceptibility testing was conducted via the broth micro-dilution method following ISO 20776-1 standards. MICs was determined using the CLSI broth dilution method for polymyxin B. |
| Isolate collection method | Systematically gathered from various hospital laboratories and forwarded to a central microbiology lab for identification and susceptibility testing. |
| Type of surveillance | Isolates were collected specifically for surveillance. |
| Methodology and Breakpoints: | Broth microdilution according to CLSI guidelines. |
| Contains pediatric data? | NA |
| Contains genotype data? | NA |
| Number of isolates | 232 |
| Date last updated | 15-02-2020 |
| Expected frequency of updates to the dataset | Study completed |
| Dataset format | Excel |
| Supporting documents to be provided | Protocol |
| Additional information | No |
| Publications | https://elibrary.escmid.org/?search%5Bfrom%5D=0&search%5Bquery%5D=payasi&search%5Bdate%5D=#results |
Genetic Assessment and Surveillance of Antibiotic Resistance (GASAR) Study (2022 – ongoing)
Conducted by Venus Remedies
Active: 2022 – Ongoing
Countries: India
Primary Objective
To examine the antimicrobial susceptibility profiles and resistance mechanisms of clinical isolates gathered from India. This study focused on key gram-negative pathogens and their resistance patterns to inform and guide treatment strategies.
| Protocol Summary | The GASAR Study (2022-ongoing) collected 494 non-duplicate bacterial isolates (first reporting period) from a tertiary-care hospital in India. The isolates included Escherichia coli (283), Klebsiella pneumoniae (144), Pseudomonas aeruginosa (39), and Acinetobacter baumannii (28). The study involved phenotypic characterization to identify ESBLs, MBLs, carbapenemases, and cephalosporinases, and used PCR for genotypic analysis of specific resistance genes (blaTEM, blaSHV, blaCTX-M, blaVIM, blaNDM, blaIMP, blaOXA, blaKPC, blaAmpC). Susceptibility was assessed using the broth microdilution method according to CLSI guidelines, and MIC determination was performed with the CLSI broth dilution method for polymyxin B. |
| Isolate collection method | Systematically gathered from various hospital laboratories and forwarded to a central microbiology lab at Venus Medicine Research Centre for identification and susceptibility testing. |
| Type of surveillance | Isolates were collected specifically for surveillance. |
| Methodology and Breakpoints: | Broth microdilution according to CLSI guidelines. |
| Contains pediatric data? | NA |
| Contains genotype data? | Yes |
| Number of isolates | 494 |
| Date last updated | 04-07-2023 |
| Expected frequency of updates to the dataset | Annually |
| Dataset format | Excel |
| Supporting documents to be provided | Protocol |
| Additional information | No |
| Publications | https://elibrary.escmid.org/?search%5Bfrom%5D=0&search%5Bquery%5D=payasi&search%5Bdate%5D=#results |