16-ID-02. Standardized Surveillance Case Definition for Histoplasmosis

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1 16-ID-02 Cmmittee: Infectius Disease Title: tandardized urveillance Case Definitin fr Histplasmsis I. tatement f the Prblem Histplasmsis, caused by the fungus Histplasma capsulatum, encmpasses a spectrum f disease ranging frm self-limited respiratry illness t disseminated infectin. H. capsulatum is an envirnmental fungus fund wrldwide that replicates well in nitrgen-rich sil, such as sil enriched by bird and bat drppings. In the United tates, histplasmsis is caused primarily by Histplasma capsulatum var. capsulatum is endemic in the hi and Mississippi River valleys as well as ther areas. Anther variety f H. capsulatum (var. dubisii, smetimes referred t as H. dubisii), causes a disease knwn as African histplasmsis, which has rarely been reprted in the United tates. There is n standardized case definitin fr histplasmsis in the United tates, limiting ur understanding f its epidemilgy and hw and why utbreaks ccur. This psitin statement prpses a standardized case definitin fr histplasmsis. II. Backgrund and Justificatin Histplasmsis is ne f the mst cmmn endemic mycsis in the United tates, yet the true number f cases is unknwn and is difficult t ascertain withut a standardized case definitin (1-2). Based n hspital discharge data, >5,000 histplasmsis-assciated hspitalizatins were estimated t have ccurred in 2012; hwever, the ttal number f annual histplasmsis cases is likely much higher because mst persns with this infectin d nt require hspitalizatin (3). Histplasmsis is typically acquired thrugh inhalatin f spres fund in sil cntaminated with bird r bat drppings. N direct human-t-human transmissin has been reprted. ymptms generally develp 3 14 days after expsure, althugh many infectins are asymptmatic (4-6). Acute pulmnary histplasmsis is the mst cmmn frm f disease, and symptms typically include fever, headache, malaise, and cugh. evere pulmnary disease can invlve a wide range f cmplicatins (4). Disseminated disease can als ccur, usually in immuncmprmised patients (4). Mst cases f histplasmsis are self-limited, but patients with persistent symptms r mderate r severe disease require treatment with antifungals (6). everal labratry methds are available fr diagnsis f histplasmsis, including culture, histpathlgy, and antigen, antibdy, and nucleic acid testing. Culture remains the gld standard but requires weeks t grw, and cultures are ften negative in mild t mderate pulmnary infectin (6-7). Histpathlgy is anther methd fr detecting H. capsulatum yeast in sputum, bld, r tissue samples; hwever, ther fungi can appear mrphlgically similar, such as Blastmyces dermatitidis, Candida glabrata, Cryptcccus and Cccidiides spp. (7). Antibdy testing fr histplasmsis by cmplement fixatin (CF) and immundiffusin (ID) is als available. Paired serum samples shwing sercnversin ( 4-fld rise in CF titer r detectin f M band by ID assay after dcumented negative n previus test) and detectin f H band by ID assay prvide greatest specificity, but a single serum r cerebrspinal fluid CF titer 1:32 r M band can als aid in diagnsis (6). Prductin f antibdies may nt ccur in immuncmprmised patients (7). H. capsulatum antigen testing f serum, urine, r ther bdy fluid by enzyme immunassay is als available and is highly sensitive in disseminated disease but less s in acute pulmnary disease (6). B. dermatitidis infectins can result in false-psitive antigen tests fr H. capsulatum. Detectin f H. capsulatum DNA in clinical specimens by validated nucleic acid tests, such as plymerase chain reactin (PCR), can als be used in diagnsis. Histplasmsis is nt a natinally ntifiable disease, and a standard case definitin has nt been established. The ten states and ne territry (Arkansas, Delaware, Illinis, Indiana, Kentucky, Michigan, Minnesta, Nebraska, Pennsylvania, Wiscnsin and Puert Ric) in which the disease is reprtable each have different case definitins (8). Althugh mst f the case definitins include bradly similar clinical and 16-ID-02 1

2 labratry criteria, the differences that exist limit data cmparability. Additinally, the jurisdictins cllect different labratry, clinical, and epidemilgical data elements. Mst require labratries r healthcare persnnel t reprt a case f histplasmsis within a certain timeframe t the lcal r state health department electrnically thrugh the state s surveillance system r by mailing r faxing a cmpleted disease case reprt. T address the substantial variability in hw states cnduct surveillance n histplasmsis, a wrkgrup was frmed t develp a cnsensus case definitin. Participants in this wrkgrup represented state health departments frm ten states (Arkansas, Illinis, Indiana, Kentucky, Michigan, Mississippi, Nebraska, hi, Tennessee, and Wiscnsin), CDC s Myctic Diseases Branch, and the academic cmmunity. A cnsensus surveillance definitin fr histplasmsis wuld allw fr the cmparisn f incidence f histplasmsis cases between states and aid in the investigatin f disease trends. III. tatement f the desired actin(s) t be taken 1. Utilize standard surces (e.g. reprting*) fr case ascertainment fr histplasmsis. urveillance fr histplasmsis shuld use the fllwing recmmended surces f data t the extent f cverage presented in Table III. Table III. Recmmended surces f data and extent f cverage fr ascertainment f cases f histplasmsis. Cverage urce f data fr case ascertainment Ppulatin-wide entinel sites Clinician reprting Labratry reprting Reprting by ther entities (e.g., hspitals, veterinarians, pharmacies, pisn centers) Death certificates Hspital discharge r utpatient recrds Extracts frm electrnic medical recrds Telephne survey chl-based survey ther 2016 Template 2. Utilize standardized criteria fr case identificatin and classificatin (ectins VI and VII) fr histplasmsis but d nt add histplasmsis t the Natinally Ntifiable Cnditin List. If requested by CDC, jurisdictins (e.g. tates and Territries) cnducting surveillance accrding t these methds may submit case infrmatin t CDC. CTE recmmends that all jurisdictins (e.g. tates r Territries) with legal authrity t cnduct public health surveillance fllw the recmmended methds as utlined abve. IV. Gals f urveillance T prvide infrmatin n the tempral, gegraphic, and demgraphic ccurrence f bth utbreakassciated and spradic histplasmsis cases in the United tates. 16-ID-02 2

3 V. Methds fr urveillance: urveillance fr histplasmsis shuld use the recmmended surces f data and the extent f cverage listed in Table III. The primary surce f data will be frm labratry reprting. In states where histplasmsis is a reprtable cnditin, labratries shuld reprt histplasmsis cases t public health authrities. Healthcare facilities and clinicians wh becme aware f patients with histplasmsis shuld als reprt these t public health authrities. ther data surces (e.g., death certificates r hspital discharge data) may be used as supplementary case finding methds. VI. Criteria fr case identificatin A. Narrative: A descriptin f suggested criteria fr case ascertainment f a specific cnditin. In public health jurisdictins where histplasmsis is classified as a reprtable disease r cnditin, clinicians and labratries shuld reprt t public health authrities any f the fllwing labratry results: Culture f H. capsulatum frm a clinical specimen, Identificatin f characteristic H. capsulatum yeast in tissue r sterile bdy fluid by histpathlgy, 4-fld rise in H. capsulatum serum cmplement fixatin antibdy titers taken at least 2 weeks apart, Detectin in serum f H band by H. capsulatum immundiffusin antibdy test, Detectin in serum f M band by H. capsulatum immundiffusin antibdy test after a dcumented lack f M band n a previus test (i.e., sercnversin), Demnstratin f H. capsulatum-specific nucleic acid in a clinical specimen using a validated assay (i.e., PCR), Identificatin f characteristic H. capsulatum yeast in tissue r sterile bdy fluid by cytpathlgy, Detectin in serum r cerebrspinal fluid (CF) f H. capsulatum antibdies by single cmplement fixatin titer f 1:32 r greater (e.g., 1:64), Detectin in serum r cerebrspinal fluid (CF) f M band by H. capsulatum immundiffusin antibdy test withut a previus negative test, Detectin f H. capsulatum antigen in serum, urine, r ther bdy fluid by an enzyme immunassay test. Reprt t public health authrities any patient wh is suspected t have histplasmsis based n clinical suspicin and is epidemilgically linked t a cnfirmed case. Reprt t public health authrities a persn whse healthcare recrd cntains a diagnsis f histplasmsis r a persn whse death certificate lists histplasmsis a cause f death r significant cnditin cntributing t death. B. Table f criteria t determine whether a case shuld be reprted t public health authrities Table VI-B. Table f criteria t determine whether a case shuld be reprted t public health authrities. Criterin Histplasmsis Reprting Clinical Evidence Clinical suspicin f histplasmsis N Health recrd diagnsis f histplasmsis Death certificate lists histplasmsis as cause f death r significant cnditin cntributing t death Labratry Evidence Culture f H. capsulatum frm a clinical specimen Identificatin f characteristic H. capsulatum yeast in tissue r sterile bdy fluid by histpathlgy 16-ID-02 3

4 4-fld rise in H. capsulatum serum cmplement fixatin antibdy titers taken at least 2 weeks apart Detectin in serum f H band by H. capsulatum immundiffusin antibdy test Detectin in serum f M band by H. capsulatum immundiffusin antibdy test after a dcumented lack f M band n a previus test (i.e., sercnversin) Demnstratin f H. capsulatum-specific nucleic acid in a clinical specimen using a validated assay (i.e., PCR). Identificatin f characteristic H. capsulatum yeast in tissue r sterile bdy fluid by cytpathlgy Detectin in serum r cerebrspinal fluid (CF) f H. capsulatum antibdies by single cmplement fixatin titer f 1:32 r greater (e.g., 1:64) Detectin in serum r cerebrspinal fluid (CF) f M band by H. capsulatum immundiffusin antibdy test withut a previus negative test Detectin f H. capsulatum antigen in serum, urine, r ther bdy fluid by an enzyme immunassay test Epidemilgical Evidence Epidemilgically linked t a cnfirmed case N 2016 Template Ntes: = This criterin alne is ufficient t reprt a case. N = All N criteria in the same clumn are Necessary t reprt a case. = At least ne f these (ne r mre) criteria in each categry (e.g., clinical evidence and labratry evidence) in the same clumn in cnjunctin with all N criteria in the same clumn is required t reprt a case. * A requisitin r rder fr any f the labratry tests is sufficient t meet the reprting criteria. C. Disease-specific data elements Clinical Infrmatin: Descriptin f clinical symptms and signs f illness Date f nset Hspitalizatin Underlying diseases/c-infectins Labratry Infrmatin: Date f cllectin f first specimen that indicated histplasmsis pecimens indicative f histplasmsis: pecimen type pecimen cllectin date Labratry test perfrmed Results, including H. capsulatum variety (i.e., var. capsulatum r var. dubisii), if knwn Epidemilgical Infrmatin: Envirnmental expsure likely t cntribute risk f illness ccupatin Travel histry frm past 2 years utside f state f residence utside f the United tates 16-ID-02 4

5 VII. Case Definitin fr Case Classificatin A. Narrative: Descriptin f criteria t determine hw a case shuld be classified. Clinical Criteria Clinical presentatin includes either: At least tw f the fllwing clinical findings: fever, chest pain, cugh, myalgia, shrtness f breath, headache, r erythema ndsum/erythema multifrme rash; R At least ne f the fllwing clinical findings: Abnrmal chest imaging (e.g., pulmnary infiltrates, cavitatin, enlarged hilar r mediastinal lymph ndes, pleural effusin); Clinical evidence f disseminated disease: gastrintestinal ulceratins r masses; skin r mucsal lesins; peripheral lymphadenpathy; pancytpenia, as evidence f bne marrw invlvement; enlargement f the liver, spleen, r abdminal lymph ndes; r meningitis, encephalitis, r fcal brain lesin. Labratry Criteria Cnfirmatry labratry criteria: Culture f H. capsulatum frm a clinical specimen, Identificatin f characteristic H. capsulatum yeast in tissue r sterile bdy fluid by histpathlgy, 4-fld rise in H. capsulatum serum cmplement fixatin antibdy titers taken at least 2 weeks apart, Detectin in serum f H band by H. capsulatum immundiffusin antibdy test, Detectin in serum f M band by H. capsulatum immundiffusin antibdy test after a dcumented lack f M band n a previus test (i.e., sercnversin), Demnstratin f H. capsulatum-specific nucleic acid in a clinical specimen using a validated assay (i.e., PCR). Nn-cnfirmatry labratry criteria: Identificatin f characteristic H. capsulatum yeast in tissue r sterile bdy fluid by cytpathlgy, Detectin in serum r cerebrspinal fluid (CF) f H. capsulatum antibdies by single cmplement fixatin titer f 1:32 r greater (e.g., 1:64), Detectin in serum r cerebrspinal fluid (CF) f M band by H. capsulatum immundiffusin antibdy test withut a previus negative test, Detectin f H. capsulatum antigen in serum, urine, r ther bdy fluid by an enzyme immunassay test. Epidemilgic Linkage Epidemilgically linked (e.g.: cmmn envirnmental expsure) with a cnfirmed case. Cnfirmed Case: A clinically-cmpatible case that meets cnfirmatry labratry criteria. 16-ID-02 5

6 Prbable Case: A clinically-cmpatible case that meets nn-cnfirmatry labratry criteria*; R A case that meets cnfirmatry labratry criteria, but n clinical infrmatin is available; R A clinically-cmpatible case that des nt meet labratry criteria, but is epidemilgically linked t a cnfirmed case. *Illness in a persn with cmpelling evidence (e.g., culture, histpathlgy, sercnversin) f a different fungal infectin, such as blastmycsis r cccidiidmycsis, and meeting nly nn-cnfirmatry labratry criteria fr histplasmsis shuld nt be cunted as a case f histplasmsis since ther fungal infectins can cause false psitive H. capsulatum antigen and antibdy test results. Criteria t distinguish a new case f this disease r cnditin frm reprts r ntificatins which shuld nt be enumerated as a new case fr surveillance Fllwing acute histplasmsis, cmplement fixatin titers and M-band n immundiffusin antibdy testing typically remain elevated fr several years. Peple with chrnic histplasmsis may have cultures yielding H. capsulatum and psitive antigen enzyme immunassay testing fr mnths r mre. Distinct repeat infectins have als been reprted, typically invlving acute pulmnary disease in endemic areas. T minimize duplicate cunting f chrnic infectins and missed repeat acute infectins, illnesses in a given persn shuld be cunted n mre than nce every 24 mnths. B. Classificatin Tables Table VII-B. Criteria fr defining a case f histplasmsis. Criterin Cnfirmed Prbable Clinical Evidence At least tw f the fllwing: fever, chest pain, cugh, myalgia, shrtness f breath, headache, r erythema ndsum/erythema multifrme rash N N N Abnrmal chest imaging Clinical evidence f disseminated disease Labratry Evidence Culture f H. capsulatum frm a clinical specimen Identificatin f characteristic H. capsulatum yeast in tissue r sterile bdy fluid by histpathlgy 4-fld rise in H. capsulatum serum cmplement fixatin antibdy titers taken at least 2 weeks apart Detectin in serum f H band by H. capsulatum immundiffusin antibdy test Detectin in serum f M band by H. capsulatum immundiffusin antibdy test after a dcumented lack f M band n a previus test (i.e., sercnversin) Demnstratin f H. capsulatum-specific nucleic acid in a clinical specimen using a validated assay (i.e., PCR). Identificatin f characteristic H. capsulatum yeast in tissue r sterile bdy fluid by cytpathlgy 16-ID-02 6

7 Detectin in serum r cerebrspinal fluid (CF) f H. capsulatum antibdies by single cmplement fixatin titer f 1:32 r greater (e.g., 1:64) Detectin in serum r cerebrspinal fluid (CF) f M band by H. capsulatum immundiffusin antibdy test withut a previus negative test Detectin f H. capsulatum antigen in serum, urine, r ther bdy fluid by an enzyme immunassay test Epidemilgic Evidence Epidemilgically linked t a cnfirmed case N N Criteria t distinguish a new case At least 24 mnths have lapsed since last reprted nset f histplasmsis in same individual N N N N N N N 2016 Template Ntes: = This criterin alne is ufficient t classify a case. N = All N criteria in the same clumn are Necessary t classify a case. A number fllwing an N indicates that this criterin is nly required fr a specific disease/cnditin subtype (see belw). If the absence f a criterin (i.e., criterin NT present) is required fr the case t meet the classificatin criteria, list the Absence f criterin as a Necessary cmpnent. = At least ne f these (ne r mre) criteria in each categry (e.g., clinical evidence and labratry evidence) in the same clumn in cnjunctin with all N criteria in the same clumn is required t classify a case. (These criteria are alternatives, which mean that a single clumn will have either n criteria r multiple criteria; n clumn shuld have nly ne.) A number fllwing an indicates that this criterin is nly required fr a specific disease/cnditin subtype. VIII. Perid f urveillance urveillance shuld be n-ging. I. Data sharing/release and print criteria Data will be used t mnitr trends f histplasmsis ver time. Data may als be used t cmpare histplasmsis cases acrss jurisdictins. Infrmatin may be distributed amng states and territries r t CDC depending n the current epidemilgic situatin r jurisdictin specific prtcls. Unusual situatins may increase the need fr cmmunicatin. Frequency f cases, epidemilgic distributin, and ther factrs will influence cmmunicatins. tates and territries will share data with CDC accrding t jurisdictin specific prtcls. tate-specific data n cases, if shared with CDC, will be verified befre publicatin.. Revisin Histry Nne. 16-ID-02 7

8 I. References 1. Chu J, Feudtner C, Heydn K, Walsh T, Zautis T. Hspitalizatins fr endemic mycses: a ppulatinbased natinal study. Clinical Infectius Diseases. 2006;42(6): Mans N, Ferebee, Kerschbaum W. Gegraphic variatin in the prevalence f histplasmin sensitivity. Diseases f the Chest. 1956;29(6): Benedict K, Derad G, Mdy R. Histplasmsis-assciated hspitalizatins in the United tates, pen Frum Infect Dis. 2016;3(1):fv Kauffman C. Histplasmsis: a clinical and labratry update. Clinical Micrbilgy Reviews. 2007;20(1): Nett R, killman D, Riek L, Davis B, Blue, undberg E, et al. Histplasmsis in Idah and Mntana, UA, Emerg Infect Dis. 2015;21(6): Wheat L, Freifeld A, Kleiman M, Baddley J, McKinsey D, Lyd J, et al. Clinical practice guidelines fr the management f patients with histplasmsis: 2007 update by the Infectius Diseases ciety f America. Clinical Infectius Diseases. 2007;45(7): Guarner J, Brandt M. Histpathlgic diagnsis f fungal infectins in the 21st century. Clinical Micrbilgy Reviews. 2011;24(2): Centers fr Disease Cntrl and Preventin. Histplasmsis Types f Diseases Fungal Diseases CDC. Cdc.gv [cited 2016 Mar 14]. Available frm: II. Crdinatin Agencies fr Respnse (1) Centers fr Disease Cntrl and Preventin Thmas R. Frieden, MD, MPH Directr 1600 Cliftn Rad NE Atlanta, GA txf2@cdc.gv III. ubmitting Authr: (1) Active Member Assciate Member Dirk Haselw, MD, PhD, M tate Epidemilgist and Medical Directr fr Cmmunicable Disease Arkansas Department f Health 4815 W. Markham t. lt 48 Little Rck, AR Dirk.Haselw@arkansas.gv C-Authr: (1) Active Member Assciate Member Virgie. Fields, M CDC/CTE Applied Epidemilgy Fellw Arkansas Department f Health 4815 W. Markham t. lt 48 Little Rck, AR Virgie.Fields@arkansas.gv 16-ID-02 8

9 Additinal C-Authrs: (2) Active Member Assciate Member Vernica Fialkwski, MPH CDC/CTTE Applied Epidemilgy Fellw Michigan Department f Health and Human ervices 201 Twnsend t. 5th Flr Lansing, MI fialkwskiv@michigan.gv (3) Active Member Assciate Member uzanne Gibbns-Burgener, DVM, PhD Infectius Diseases Epidemilgist Wiscnsin Department f Health ervices Wiscnsin Divisin f Public Health 1 W. Wilsn t, Rm 272 Madisn, WI uzanne.gibbnsburgener@dhs.wi.gv (4) Active Member Assciate Member Brendan R. Jacksn, MD, MPH Medical Epidemilgist Centers fr Disease Cntrl and Preventin 1600 Cliftn Rad NE, M C-09 Atlanta, GA brjacksn1@cdc.gv (5) Active Member Assciate Member Caitlin Pedati, MD, MPH Epidemic Intelligence ervice fficer Nebraska Department f Health and Human ervices 300 Centennial Mall uth Lincln, NE caitlin.pedati@nebraska.gv (6) Active Member Assciate Member Kimberly igns, DVM Zntic Disease Epidemilgist Michigan Department f Health and Human ervices 201 Twnsend t. 5th Flr Lansing, MI signsk@michigan.gv 16-ID-02 9