TY - JOUR A1 - Bender, Jennifer A1 - Haller, Sebastian A1 - Pfeifer, Yvonne A1 - Hogardt, Michael A1 - Hunfeld, Klaus-Peter A1 - Thürmer, Andrea A1 - Zanuzdana, Arina A1 - Werner, Markus A1 - Kunz, Bernd A1 - Eisenberger, David A1 - Pfennigwerth, Niels Ernst A1 - Kempf, Volkhard A. J. A1 - Werner, Guido A1 - Eckmanns, Tim T1 - Combined clinical, epidemiological, and genome-based analysis identified a nationwide Outbreak of Burkholderia cepacia complex infections caused by contaminated mouthwash solutions T2 - Open Forum Infectious Diseases N2 - Background: In September 2018, Burkholderia cepacia complex (BCC) infections in 3 patients associated with exposure to a mouthwash solution (MWS) were reported to the Robert Koch Institute (RKI). As the product was still on the market and the scale of the outbreak was unclear, a nation-wide investigation was initiated. Methods: We aimed to investigate BCC infections/colonizations associated with MWS. Hospitals, laboratories, and public health services were informed that BCC isolates should be sent to the RKI. These isolates were typed by pulsed-field gel electrophoresis (PFGE) and whole-genome sequencing (WGS) including development of an ad hoc core genome MLST (cgMLST) scheme. Results: In total, 36 patients from 6 hospitals met the case definition, the last patient in November 2018. Twenty-nine isolates from 26 of these patients were available for typing. WGS analysis revealed 2 distinct cgMLST clusters. Cluster 1 (Burkholderia arboris) contained isolates from patients and MWS obtained from 4 hospitals and isolates provided by the manufacturer. Patient and MWS isolates from another hospital were assigned to cluster 2 (B. cepacia). Conclusions: The combined clinical, epidemiological, and microbiological investigation, including whole-genome analysis, allowed for uncovering a supraregional BCC outbreak in health care settings. Strains of B. arboris and B. cepacia were identified as contaminating species of MWS bottles and subsequent colonization and putative infection of patients in several hospitals. Despite a recall of the product by the manufacturer in August 2018, the outbreak lasted until December 2018. Reporting of contaminated medical products and recalls should be optimized to protect patients. KW - Burkholderia arboris KW - outbreak KW - clonal transfer KW - mouthwash solution KW - medical device KW - burkholderia KW - disease outbreaks KW - electrophoresis KW - gel KW - pulsed-field KW - genome KW - mouthwash KW - infections KW - microbial colonization KW - familial amyloid nephropathy with urticaria and deafness KW - burkholderia cepacia complex infections Y1 - 2022 UR - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/84422 UR - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-844221 SN - 2328-8957 N1 - Supplementary materials are available at Open Forum Infectious Diseases online. Consisting of data provided by the author that are published to benefit the reader. The posted materials are not copyedited. The contents of all supplementary data are the sole responsibility of the authors. Questions or messages regarding errors should be addressed to the author. N1 - This work was supported by funds from the German Federal Ministry of Health to the National Consiliary Laboratory. VL - 9 IS - 5, art. ofac114 SP - 1 EP - 9 PB - Oxford University Press CY - Oxford ER -