Christin Schröder

Dramatic increase in vancomycin-resistant enterococci in Germany

OBJECTIVES Among European countries, Germany has one of the highest proportions of vancomycin-resistant Enterococcus faecium bloodstream infections. The aim of this study was to investigate the development of vancomycin-resistant enterococci (VRE) in German hospitals and to consider the regional distribution of VRE in Germany. METHODS Data from three components of the German national nosocomial surveillance system (KISS) from the period 2007-12 were used for analysis: ICU-KISS data on nosocomial primary bloodstream infections and urinary tract infections from intensive care units (ICUs); OP-KISS data on surgical site infections from surgical departments; and Pathogen-KISS data concentrating on VRE cases (infections and colonizations) in ICUs. Trends over time were calculated and a map according to German federal states was prepared. RESULTS Data from up to 645 ICUs and 681 surgical departments for 2 year periods from 2007 to 2012 were analysed. The proportion of VRE increased significantly for surgical site infections (526%; P < 0.01) and bloodstream infections (265%; P < 0.01) and non-significantly for urinary tract infections (278%; P = 0.07). A large subgroup of ICUs also reported VRE cases in the same period, with a significant increase of 282%. The mapping of federal states showed large variation in VRE proportions and incidence rates in a belt of states with significantly higher VRE proportions from west (North Rhine-Westphalia) to east (Saxony). CONCLUSIONS The high overall VRE proportion in Germany is mainly due to the situation in four states. There is an urgent need to analyse the epidemiology of VRE in detail to develop appropriate infection control strategies.

The reduction of nosocomial MRSA infection in Germany: an analysis of data from the Hospital Infection Surveillance System (KISS) between 2007 and 2012.

BACKGROUND Infections with multiresistant Gram negative pathogens are rising around the world, but many European countries have recently seen a decline in infections due to methicillin resistant Staphylococcus aureus (MRSA). We determined the percentage of nosocomial Staphylococcus aureus infections in Germany that were accounted for by MRSA in the past six years and looked for regional differences in the overall downward trend. METHODS Data from the German Hospital Infection Surveillance System (Krankenhaus-Infektions-Surveillance-System, KISS) from the years 2007-2012 were analyzed. In intensive care units, data on the following nosocomial infections were registered: primary sepsis, lower respiratory tract infections, and urinary tract infections; in surgical wards, data on postoperative wound infections were collected. RESULTS The number of participating intensive care units varied from 465 to 645, while the number of participating surgical wards varied from 432 to 681. Over the period 2007-2012, the percentage of nosocomial Staphylococcus aureus infections that were due to MRSA dropped significantly, from 33% to 27%. More specifically, the percentage of infections due to MRSA dropped from 36% to 31% for primary sepsis and from 36% to 30% for lower respiratory tract infections. Regression analysis revealed significantly lower MRSA fractions in the German states of Brandenburg (odds ratio [OR] 0.41), Bavaria (OR 0.73), and Saxony-Anhalt (OR 0.53), with higher fractions in Berlin (OR 1.59), Mecklenburg-West Pomerania (OR 1.91), Lower Saxony (OR 1.85), and North Rhine-Westphalia (OR 1.55). There were no significant differences in the remaining German states. CONCLUSION In Germany, the percentage of nosocomial Staphylococcus aureus infections due to MRSA dropped significantly over the period 2007-2012. The causes of this decline are unclear; it may have resulted from human intervention, pathogen biology, or both.

Epidemiology of healthcare associated infections in Germany: Nearly 20 years of surveillance

OBJECTIVE To describe the epidemiology of healthcare-associated infections (HAI) in hospitals participating in the German national nosocomial infections surveillance system (KISS). METHOD The epidemiology of HAI was described for the surveillance components for intensive care units (ITS-KISS), non-ICUs (STATIONS-KISS), very low birth weight infants (NEO-KISS) and surgical site infections (OP-KISS) in the period from 2006 to 2013. In addition, risk factor analyses were performed for the most important infections of ICU-KISS, NEO-KISS and OP-KISS. RESULTS Data from a total of 3,454,778 ICU patients from 913 ICUs, 618,816 non-ICU patients from 142 non-ICU wards, 53,676 VLBW from 241 neonatal intensive care units (NICU) and 1,005,064 surgical patients from operative departments from 550 hospitals were used for analysis. Compared with baseline data, a significant reduction of primary bloodstream infections (PBSI) and lower respiratory tract infections (LRTI) was observed in ICUs with the maximum effect in year 5 (or longer participation) (incidence rate ratio 0.60 (CI95 0.50-0.72) and 0.61 (CI95 0.52-0.71) respectively). A significant reduction of PBSI and LRTI was also observed in NEO-KISS when comparing the baseline situation with the 5th year of participation (hazard ratio 0.70 (CI95 0.64-0.76) and 0.43 (CI95 0.35-0.52)). The effect was smaller in operative departments after the introduction of OP-KISS (OR 0.80; CI95 0.64-1.02 in year 5 or later for all procedure types combined). Due to the large database, it has not only been possible to confirm well-known risk factors for HAI, but also to identify some new interesting risk factors like seasonal and volume effects. CONCLUSIONS Participating in a national surveillance system and using surveillance data for internal quality management leads to substantial reduction of HAI. In addition, a surveillance system can identify otherwise not recognized risk factors which should - if possible - be considered for infection control management and for risk adjustment in the benchmarking process.

Regional distribution of nosocomial infections due to ESBL-positive Enterobacteriaceae in Germany: data from the German National Reference Center for the Surveillance of Nosocomial Infections (KISS)

Surveillance systems for hospital infections are reporting increasing rates of extended-spectrum β-lactamase (ESBL)-positive Enterobacteriaceae in Europe. We aimed to perform a national survey on this trend and on the regional distribution of nosocomial infections due to ESBL-positive Enterobacteriaceae in German hospitals. Data from 2007 to 2012 from two components of the German national nosocomial infection surveillance system were used for this analysis. The data derive from intensive care units and surgical departments. Independent factors determining the proportion of ESBL-positive Enterobacteriaceae among nosocomial infections due to Enterobacteriaceae and changes in its regional distribution (broken down into German federal states) were calculated by regression analysis. From 2007 to 2012, the data showed a significantly increasing proportion of ESBL-positive Enterobacteriaceae in surgical site infections (from 11.46 to 15.38, 134%, p 0.003), urinary tract infections (9.36 to 16.56, 177%, p <0.001) and lower respiratory tract infections (11.91 to 14.70, 123%, p <0.001) due to Enterobacteriaceae. Factors independently associated with a growing proportion were: Thuringia (p 0.009; odds ratio (OR) 1.53), North Rhine-Westphalia (p <0.001; OR 1.41) and general surgery ward (p 0.002; OR 1.47). The proportion of ESBL-positive Enterobacteriaceae in nosocomial infections has significantly increased in Germany over the last 6 years. Hospitals in Central Germany and surgical departments in all of Germany are especially affected by this development.

Legal basis of the Advanced Therapies Regulation

Advanced therapy medicinal products consist of gene therapy, somatic cell therapy and tissue engineered products. Due to their specific manufacturing process and mode of action these products require specially tailored legislation. With Regulation (EC) No. 1394/2007, these needs have been met. Definitions of gene therapy, somatic cell therapy and tissue engineered products were laid down. A new committee, the Committee for Advanced Therapies, was founded, special procedures such as the certification procedure for small- and medium-sized enterprises were established and the technical requirements for Marketing Authorisation Applications (quality, non-clinical and clinical) were revised.ZusammenfassungArzneimittel für Neuartige Therapien umfassen Gentherapeutika, somatische Zelltherapien und biotechnologisch bearbeitete Gewebeprodukte. Ihre spezifischen Herstellungsprozesse und ihr spezifischer Wirkmechanismus erfordern eine speziell darauf zugeschnittene Gesetzgebung. Diese liegt mit der Verordnung (EG) 1394/2007 vor. Gentherapeutika, somatische Zelltherapien und biotechnologisch bearbeitete Gewebeprodukte werden hier definiert. Ein neuer Ausschuss für neuartige Therapien (Comittee for Advanced Therapies, CAT) wird zur Bewertung dieser Arzneimittel gegründet: Neue Verfahren wie das Zertifizierungsverfahren, das kleine und mittelständische Unternehmen in Anspruch nehmen können, werden eingerichtet. Außerdem sind die technischen Anforderungen für den Antrag auf Marktzulassung in den Bereichen Qualität, Nicht-Klinik und Klinik angepasst worden.

Case vignettes to evaluate the accuracy of identifying healthcare-associated infections by surveillance persons

BACKGROUND National surveillance systems depend on accurate and reproducible diagnosis of infections. AIM To investigate the effect of accuracy of diagnosing healthcare-associated infections (HCAIs) on HCAI rates in a national healthcare-associated surveillance system. METHODS Data from the validation process from the intensive care unit (ICU) surveillance component of the German Krankenhaus Infektions Surveillance System (KISS; Hospital Infection Surveillance System) were used to calculate the accuracy of diagnosing HCAI for each individual surveillance person (SP) responsible for surveillance of HCAI in the ICU of his or her hospital. Multivariate analyses were performed to identify factors that were attributed to surveillance accuracy. FINDINGS A total of 189 SPs responsible for surveillance in 218 ICUs assessed 30 case vignettes. The chance of belonging to the group of SPs with high accuracy was increased by being a physician (odds ratio: 3.14; P = 0.02) and by being an external SP (odds ratio: 4.69; P ≤ 0.01). ICU HCAI rates depend on the sensitivity of the ICUs SP [incidence rate ratio (IRR): 1.28 (1.07, 1.53); P ≤ 0.01]. High sensitivity increases healthcare-associated urinary tract infection rates [IRR: 1.33 (1.02, 1.75); P = 0.03] and bloodstream infection rates [IRR: 1.33 (1.06, 1.68); P = 0.01]. High specificity was not a significant factor. CONCLUSION In light of the link between sensitivity of diagnosing HCAI by case vignettes and the ICU HCAI rates, this validation method can be recommended for validation of other surveillance systems.

ICU ward design and nosocomial infection rates: a cross-sectional study in Germany

BACKGROUND There is increasing interest in the effects of hospital and ward design on multi-faceted infection control. Definitive evidence is rare and the state of knowledge about current ward design is lacking. OBJECTIVE To collect data on the current status of ward design for intensive care units (ICUs) and to analyse associations between particular design factors and nosocomial infection rates. METHODS In 2015, operational infrastructure data were collected via an online questionnaire from ICUs participating voluntarily in the German nosocomial infection surveillance system (KISS). A multi-variate analysis was subsequently undertaken with nosocomial infection rates from the KISS database from 2014 to 2015. FINDINGS In total, 534 ICUs submitted data about their operational infrastructure. Of these, 27.1% of beds were hosted in single-bed rooms with a median size of 18m2 (interquartile range 15-21m2), and 73.5% of all ICU beds had a hand rub dispenser nearby. The authors were able to match 266 ICUs in the multi-variate analysis. ICUs with openable windows in patient rooms were associated with lower device-associated lower respiratory tract infections [odds ratio (OR) 0.73, 95% confidence interval (CI) 0.58-0.90]. ICUs with >40% two-bed rooms were associated with lower primary bloodstream infection rates (OR 0.66, 95% CI 0.51-0.86). CONCLUSION Only minor associations were found between design factors and ICU infection rates. Most were surrogates for other risk factors.

Implementation of an electronic hospital outbreak detection system

The early detection of infectious disease outbreaks plays a key role for infection control professionals (ICPs) in a hospital in order to initiate infection control measures. Hospital information systems do not offer ordinarily support in this field. We identified the need for an easy to use, web-based, electronic system to detect unusual clusters of positive microbiology results.

Hospital ownership: a risk factor for nosocomial infection rates?

BACKGROUND In some countries, a relationship between hospital ownership and the occurrence of healthcare-associated infection (HCAI) rates has been described. AIM To investigate the association between hospital ownership and occurrence of HCAI in Germany. METHODS Five different components of the German national nosocomial infection surveillance system were analysed with regard to the influence of hospital ownership in the period 2014-2016. Endpoints included ventilator-associated pneumonia, central-venous-catheter-associated bloodstream infections, urinary-catheter-associated urinary tract infections, surgical site infections (SSI) following hip prosthesis and colon surgery, meticillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile infections (CDI) and hand rub consumption per 1000 patient-days. Three hospital ownership types (public, non-profit and private) were analysed using univariate and multi-variate methods. FINDINGS The distribution of hospitals according to the three ownership types was similar in all components. In total, 661 intensive care units (ICUs), 149 departments performing colon procedures, and 349 departments performing hip prosthesis were included. In addition, 568 hospitals provided their MRSA rates and 236 provided their CDI rates, and 1833 ICUs and 12,934 non-ICUs provided their hand rub consumption data. In general, the differences between the hospital types were rather small and not significant for the ICUs. In the multi-variate analysis, public hospitals had a lower SSI rate following hip prosthesis (odds ratio 0.80, 95% confidence interval 0.65-0.99). CONCLUSION Hospital ownership was not found to have a major influence on the incidence of HCAI in Germany.

High admission prevalence of fluoroquinolone resistance in third-generation cephalosporin-resistant Enterobacteriaceae in German university hospitals

Objectives Fluoroquinolone resistance (FQR) in third-generation cephalosporin-resistant Enterobacteriaceae (3GCRE) presents serious limitations to antibiotic therapy. The aim of this study was to investigate whether the FQR proportion among 3GCRE differs between community-acquired (CA) and hospital-acquired (HA) isolates. Methods In a prospective observational study covering 2014 and 2015, we monitored the occurrence of 3GCRE in adult hospitalized patients in six German university hospitals. 3GCRE clinical isolates were subdivided into CA and HA. Multivariable analysis identified factors associated with in vitro non-susceptibility to ciprofloxacin. Results The dataset included 5721 3GCRE isolates of which 52.9% were HA and 52.7% exhibited FQR. Interestingly, the FQR proportion was higher in CA 3GCRE than in HA 3GCRE (overall, 60.1% versus 46.2%, respectively, P < 0.001). Multivariable analysis adjusting for age confirmed community acquisition as a risk factor for FQR [adjusted rate ratio (aRR) 1.33, 95% CI 1.17-1.53]. Escherichia coli and Klebsiella spp. were associated with a much higher FQR proportion than other Enterobacteriaceae species (aRR 8.14, 95% CI 6.86-9.65 and aRR 7.62 with 95% CI 6.74-8.61, respectively). Conclusions The high FQR proportion observed among CA 3GCRE, particularly in E. coli and Klebsiella spp., indicates that selection pressure in the outpatient setting needs to be addressed with antibiotic stewardship and other interventions in order to limit further spread of MDR.