RESET Program: Determining Prevalence of ESBL-producing Enterobacteriaceae
This solution addresses untracked strains of drug-resistant enterobacteriaceae in Germany for humans (hospitalized patients, outpatients, healthy persons), animals (livestock and pets), animal food and environment (wastewater, shed environment)
Problem DescriptionThis solution was created: 1. To determine the prevalence of ESBL-producing bacteria in humans (hospital, ambulant, community), animals (livestock, pets), animal food and the environment (wastewater). 2. To identify the respective resistance genes and analize their transferability between enterobacteriaceae. 3. To compare genetic relationship of bacterial isolates and resistance gene carrying plasmids in different settings (human, animal, environment) to evaluate the transmission pathways of ESBL-resistance.
This project was initially funded in 2010 to help researchers in Germany study recent resistance evolution in Enterobacteriaceae. It is one part of Germany's larger German Antimicrobial Resistance Strategy
(DART2020). The project brings together 10 different research entities that study all the important sources of bacterial evolution. It will continue to be funded until 2016. It's research has yielded important knowledge on possible transmission routes between animals, food and humans as well as potential reservoirs of drug-resistant bacteria. The program has been recommended by the G7 as a best-practice for Combating Antimicrobial Resistance.
Sustainable Development Goals
On September 25th 2015, countries adopted a set of goals to end poverty, protect the planet, and ensure prosperity for all as part of a new sustainable development agenda. Each goal has specific targets to be achieved over the next 15 years. This solution covers the following goals:
Social Progress Index
- Extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae: considerations for diagnosis, prevention and drug treatment.
Abstract: "Extended spectrum beta-lactamase (ESBL)-producing organisms pose unique challenges to clinical microbiologists, clinicians, infection control professionals and antibacterial-discovery scientists. ESBLs are enzymes capable of hydrolysing penicillins, broad-spectrum cephalosporins and monobactams, and are generally derived from TEM and SHV-type enzymes. ESBLs are often located on plasmids that are transferable from strain to strain and between bacterial species. Although the prevalence of ESBLs is not known, it is clearly increasing, and in many parts of the world 10-40% of strains of Escherichia coli and Klebsiella pneumoniae express ESBLs. ESBL-producing Enterobacteriaceae have been responsible for numerous outbreaks of infection throughout the world and pose challenging infection control issues. Clinical outcomes data indicate that ESBLs are clinically significant and, when detected, indicate the need for the use of appropriate antibacterial agents. Unfortunately, the laboratory detection of ESBLs can be complex and, at times, misleading. Antibacterial choice is often complicated by multi-resistance. Many ESBL-producing organisms also express AmpC beta-lactamases and may be co-transferred with plasmids mediating aminoglycoside resistance. In addition, there is an increasing association between ESBL production and fluoroquinolone resistance. Although in in vitro tests ESBLs are inhibited by beta-lactamase inhibitors such as clavulanic acid, the activity of beta-lactam/beta-lactamase inhibitor combination agents is influenced by the bacterial inoculum, dose administration regimen and specific type of ESBL present. Currently, carbapenems are regarded as the drugs of choice for treatment of infections caused by ESBL-producing organisms. Unfortunately, use of carbapenems has been associated with the emergence of carbapenem-resistant bacterial species such as Stenotrophomonas sp. or Pseudomonas sp."
- Guidelines on Good Clinical Laboratory Practice
Abstract: "A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as performance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting."
- Combating Antimicrobial Resistance Examples of Best-Practices of the G7 Countries
RESET documented on pp. 15, under the "One-Health Approach"
- RESET Germany
- Department of Biostatistics, Epidemiology and Information Processing at the University of Veterinary Medicine Hannover
- Department of Pharmacology, Toxicology and Pharmacy (TiHo-Pharma) of the University of Veterinary Medicine Hannover
- Federal Institute for Risk Assessment, Department Biological Safety (BfR Resi)
- FG13, Abt. 1, Robert Koch-Institut, Bereich Wernigerode (RKI)
- Institute for Med. Microbiology, Justus-Liebig university of Giessen
- Institute of Animal and Environmental Hygiene, Freie Universität Berlin
- Institute of Farm Animal Genetics (FLI)
- Institute of Hygiene and Environmental Medicine, Charite Universitätsmedizin Berlin
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|STAGE||SPECIALIST SKILLS REQUIRED||EXAMPLE ACTIVITIES||RISK LEVEL AND HANDLING||FINANCE REQUIRED||KINDS OF EVIDENCE GENERATED||GOAL|
|Developing and testing3||Mix of design and implementation skills|
|A stronger case with cost and benefit projections developed through practical trials and experiments, involving potential users||Demonstration that the idea works, or evidence to support a reworking of the idea|