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Biological/Public Health Threat (Human) – IV Medical Supply Contamination: Chile, Colombia, South America

2016/03/22

SAROCLADIUM KILIENSE FUNGEMIA – COLOMBIA, CHILE: CONTAMINATED INTRAVENOUS MEDICATION, 2013-2014
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Published Date: 2016-03-22 12:54:33
Subject: PRO/EDR> Sarocladium kiliense fungemia – Colombia, Chile: contam iv med, 2013-14
Archive Number: 20160322.4109374

Date: Sun 20 Mar 2016
Source: AZ Business Magazine [edited]

The Translational Genomics Research Institute (TGen), working with international investigators, discovered the source of a potential deadly blood infection in more than 50 South American cancer patients. Using advanced genomic sequencing, TGen was able to track a potentially deadly and therapy-resistant fungus, _Sarocladium kiliense_, to a tainted anti-nausea medication given to dozens of cancer patients in Chile and Colombia, according to a report in Emerging Infectious Diseases, published by the CDC [US Centers for Disease Control and Prevention].

“Contamination of medical products, particularly with environmental fungi, poses growing concern and a public health threat, especially in vulnerable populations such as cancer patients,” said Dr David Engelthaler, director of Programs and Operations for TGen’s Pathogen Genomics Division in Flagstaff, Arizona. “Increased vigilance and the use of advanced technologies are needed to rapidly identify the likely sources of infection to efficiently guide epidemiologic investigations and initiate appropriate control measures,” said Dr Engelthaler, Arizona’s former state epidemiologist.

This bloodstream-infection outbreak, from June 2013-January 2014, included a cluster of cases at 8 hospitals in Santiago, the capital of Chile. All of the patients infected with _S. kiliense_ received ondansetron from the same source, a pharmaceutical company in Colombia. 2 of 3 lots of unopened ondansetron, tested by the Chilean Ministry of Health, yielded vials contaminated with _S. kiliense_, forcing a recall of all ondansetron in Chile made by the Colombian manufacturer. Subsequently, Colombian officials discovered 14 other cases in which patients, given ondansetron from the same Colombian pharmaceutical firm, were infected with _S. kiliense_. The source of the contamination was identified only as “pharmaceutical company A” in the CDC report.

_S. kiliense_ has been implicated previously in healthcare-related infections, but the lack of available typing methods has precluded the ability to substantiate sources. “The use of whole-genome sequence typing (WGST) to investigate fungal outbreaks has become integral to epidemiologic investigations,” Dr Engelthaler said. “Our WGST analysis demonstrated that the patient isolates from Chile and Colombia were nearly genetically indistinguishable from those recovered from the unopened medication vials, indicating the likely presence of a single-source infection.”

communicated by:
ProMED-mail from HealthMap Alerts
<promed@promedmail.org>

[The publication referred to above is:
Etienne KA, Roe CC, Smith RM, et al. Whole-genome sequencing to determine origin of multinational outbreak of _Sarocladium kiliense_ bloodstream infections. Emerg Infect Dis. 2016; 22: 476-481 http://wwwnc.cdc.gov/eid/article/22/3/pdfs/15-1193.pdf.

ProMED-mail previously published a request for information regarding this outbreak (Fungal infection, contaminated drug – Chile: S kiliense, pediatric oncology, RFI 20140219.2286332). Like the much larger USA outbreak of _Exserohilum rostratum_, the contaminated medication was produced by an “assembly company” (see below), which seems similar to a compounding pharmacy. Both of these molds have rarely been associated with human infection and might be considered as non-virulent. Virulence, however, is not really a property of an organism per se but rather a combination of factors occurring at the pathogen/potential host interface. Clearly, by introducing this organism into the body with corticosteroids (which can affect the local immune response), it can produce quite serious and potentially lethal infections, as occurred in the _E. rostratum_ outbreak. Likely, introducing the mold in the bloodstream of profoundly immunocompromised patients can do likewise. Similar whole-genome analysis had been performed by the same group for _E. rostratum_ (1).

The current nomenclature of this mold was revised from acremonium by Summerbell and colleagues (2) in 2011. My colleague ML wrote in the previous posting: “Sarocladium are filamentous fungi with characteristic morphology on growth in vitro that are found in plant material and soil. The genus is important for its production of antibiotics such as cephalosporins. _S. kiliense_ has been responsible for local and systemic fungal infection (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3122737/). _S. kiliense_ can cause localized forms of infection such as keratitis (inflammation of the cornea), endophthalmitis (inflammation of the internal coats of the eye), mycetoma (chronic cutaneous and subcutaneous fungal infection), onychomycosis (fungal infection of the nail), or cutaneous infections in immunocompetent individuals; and in severely immunocompromised patients, fungemia, and disseminated infections involving multiple organs can occur. The diagnosis can be confirmed by culturing the organism from blood or other fluids, or by a tissue biopsy. It has been found to be susceptible to the anti-fungal drugs voriconazole and posaconazole, but some isolates may be resistant to amphotericin B, fluconazole, 5-fluorocytosine, and caspofungin (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3122737/).

“How contamination of intravenous ondansetron occurred is as yet unknown and the investigation continues. The drug was manufactured by Vitrofarma SA, a “Colombian assembly company, …[that] specializes in the production of sterile injectable drugs [for human and veterinarian use]” (http://bit.ly/1Pp9oDd). If ondansetron was “assembled” by Vitrofarma from various components, were the components previously contaminated elsewhere and if so, where did the components originate?”

Of interest, _S. kiliense_ has been isolated from the gut of the termite _Reticulitermes santonensis_ that were fed on beech wood xylan, as the mold produces cellulases and xylanases (3).

References
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1. Litvintseva AP, Hurst S, Gade L, et al. Whole-genome analysis of _Exserohilum rostratum_ from an outbreak of fungal meningitis and other infections. J Clin Microbiol. 2014; 52(9): 3216-22; available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4313140/.
2. Summerbell RC, Gueidan C, Schroers H-J, et al. _Acremonium_ phylogenetic overview and revision of _Gliomastix_, _Sarcocladium_ and _Trichthecium_. Stud Mycol. 2011; 68: 139-62; available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065988/.
3. Tarayre C, Bauwens J, Brasseur C, et al. Isolation and cultivation of xylanolytic and cellulolytic _Sarcocladium kiliense_ and _Trichoderma virens_ from the gut of the termite _Reticulitermes santonensis_. Environ Sci Pollut Res Int. 2015; 22(6): 4369-82; available at http://link.springer.com/article/10.1007/s11356-014-3681-2/fulltext.html.
– Mod.LL

A HealthMap/ProMED-mail map can be accessed at: http://healthmap.org/promed/p/35937.]

See Also

2015

Fungal infection, contaminated drug – USA: 2012-2014, follow up 20151030.3755591
2014

Fungal infection, contaminated drug – Chile: S kiliense, pediatric oncology, RFI 20140219.2286332
2013

Fungal infection, contaminated drug – USA (14) 20130909.1931179
Fungal infection, contaminated drug – USA (13) 20130719.1832516
Fungal infection, contaminated drug – USA: mixed cultures 20130616.1773872
Fungal infection, contaminated drug – USA (11): new outbreak, RFI 20130607.1760736
Fungal infection, contaminated drug – USA (10): (FL) new outbreak, RFI 20130604.1755114
Fungal infection, contaminated drug – USA (09): new outbreak, RFI 20130601.1749968
Fungal infection, contaminated drug – USA (08): new outbreak, RFI 20130527.1739593
Fungal infection, contaminated drug – USA (07): new outbreak, RFI 20130525.1737028
Fungal infection, contaminated drug – USA (06): (MI) 20130520.1721489
Fungal infection, contaminated drug – USA (05) 20130507.1697132
Fungal infection, contaminated drug – USA (04) 20130329.1610129
Fungal infection, contaminated drug – USA (03) 20130312.1583406
Fungal infection, contaminated drug – USA (02) 20130130.1521840
Fungal infection, contaminated drug – USA 20130101.1477868
2012

Fungal infection, contaminated drug – USA (17) 20121222.1465161
Fungal infection, contaminated drug – USA (16) 20121219.1460439
Fungal infection, contaminated drug – USA (15) 20121214.1439451
Fungal infection, contaminated drug – USA (14) 20121127.1426436
Fungal infection, contaminated drug – USA (13) 20121115.1407788
Fungal infection, contaminated drug – USA (12) 20121110.1397549
Fungal infection, contaminated drug – USA (11): complications 20121106.1391405
Fungal infection, contaminated drug – USA (10) 20121104.1390341
Fungal infection, contaminated drug – USA (09) 20121024.1361638
Fungal infection, contaminated drug – USA (08) 20121023.1358143
Fungal infection, contaminated drug – USA (07) 20121019.1352403
Fungal infection, contaminated drug – USA (06) 20121019.1348974
Fungal infection, contaminated drug – USA (05) 20121017.1347138
Fungal infection, contaminated drug – USA (04): more medications 20121016.1345302
Fungal infection, contaminated drug – USA (03): Exserohilum 20121015.1344312
Fungal infection, contaminated drug – USA (02): Exserohilum 20121014.1341916
Fungal infection, contaminated drug – USA: Exserohilum 20121014.1341591
Aspergillus meningitis – USA (09): Exserohilum 20121011.1337615
Aspergillus meningitis – USA (08) 20121011.1335715
Aspergillus meningitis – USA (07) 20121010.1333926
Aspergillus meningitis – USA (06): CDC advice 20121009.1333004
Aspergillus meningitis – USA (05) 20121008.1330309
Aspergillus meningitis – USA (04): more cases, 2nd fungus 20121007.1328893
Aspergillus meningitis – USA (03): contaminated drug 20121005.1326188
Aspergillus meningitis – USA (02): contaminated drug 20121004.1322744
Aspergillus meningitis – USA: (TN, NC) contaminated drug 20121002.1320024
………………………………………….sb/ll/mj/sh

Source:
A ProMED-mail post
ProMED-mail is a program of the International Society for Infectious Diseases


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