11-ID-16 Committee: Infectious Disease Title: National Surveillance Definition for Melioidosis I. Statement of the Problem The purpose of this position statement is to place melioidosis under consistent national surveillance. Melioidosis is considered to be a global threat by many experts (Hassan, 2010). Burkholderia pseudomallei, the pathogen that causes melioidosis, is included on the list of category B bioterrorism agents and toxins due to its suitability as a biological weapon. Although a disease predominantly of tropical climates and primarily endemic in southeast Asia, China and northern Australia, there have been recent reports of melioidosis cases seen in other parts of the world, such as in the Americas, Madagascar, Mauritius, India and elsewhere. In the United States, confirmed cases have occurred among travelers to and immigrants from areas of endemicity. B. pseudomallei has also been isolated from military personnel of all nationalities (including U.S. troops) who have served in areas endemic for melioidosis. The disease may manifest decades after exposure. One reported U.S. case has no travel history (Stewart et al., 2011). II. Background and Justification Background Melioidosis is caused by the bacterium Burkholderia pseudomallei, which is found in water and soil. Infection typically occurs through direct contact with an environmental source or through aerosolization. Person-to-person transmission is very rare. B. pseudomallei infection has been identified in humans, sheep, goats, swine, cattle, horses, dogs, cats, and some wildlife species. Melioidosis is potentially severe and fatal. The incubation period is generally 1 – 21 days (median 9 days), but disease may occur decades after exposure. With a high inoculum, symptoms may appear within a few hours of exposure. There is no vaccine. Melioidosis may present as a localized infection, pneumonia, bacteremia or disseminated infection; patients generally present with acute illness, although studies in Australia demonstrated that 15% of patients present with chronic infection, with symptoms lasting longer than 2 months (Currie, 2010). Signs and symptoms may overlap the clinical presentation other diseases (Inglis et al., 2009), such as tuberculosis or community-acquired pneumonia. Melioidosis is endemic throughout Southeast Asia, Australia, Papua New Guinea, much of the Indian subcontinent, southern China, Hong Kong, and Taiwan; and is considered highly endemic in Northeast Thailand, Malaysia, Singapore, and northern Australia. An estimated 2,000 to 5,000 patients may present with melioidosis in Northeastern Thailand every year (Dharakul and Songsivilai, 1995). Isolated cases of melioidosis have occurred in the Western Hemisphere, most frequently in Brazil, but also in Mexico, El Salvador, Panama, Ecuador, Peru, Guyana, Puerto Rico, Martinique, and Guadeloupe. There have been documented cases of melioidosis in developed countries among immigrants and international travelers who acquired the infection from a region endemic for melioidosis. Page 1 of 10 Justification Burkholderia pseudomallei is included on the list of category B bioterrorism agents and toxins., The disease may reach up to 90% mortality rate without early diagnosis in its septic form (Mandell, 2005). Also, in laboratories, melioidosis also poses a risk due to exposures that may occur when working with the organism. Establishing a surveillance definition for melioidosis would allow for consistent monitoring of incidence of cases in the United States. The International Health Regulations recommends a need for domestic surveillance to detect occurrence of diseases consistent with international public health reporting obligations. These regulations set forth guidelines to “enhance national and global public health security” as well as to assess events of potential international public health concerns (IHR, 2005). The IHR does not specify which diseases are of special importance. Criteria for improved surveillance and response capacities rely on health risks, origin or source of the disease, and factors affecting the disease emergence and transmission. Dance (2000) noted that there has been evidence of melioidosis emergence since 1991. Based on current trends, the number of melioidosis cases in the United States is likely to increase in the future. There is a need to monitor melioidosis cases in the U.S. because of the increase in international travel as well as worldwide increase in disease burden. III. Statement of the desired action(s) to be taken Establish standard reporting and case classification for melioidosis and recommend that any State or Territory conducting surveillance for this condition use these standards. IV. Goals of Surveillance 1. To provide information on the temporal, geographic, and demographic occurrence of melioidosis to facilitate its prevention and control. 2. To assist in identification of potential laboratory exposures, conduct risk assessment and provide post-exposure prophylaxis, if indicated. 3. To detect potential deliberate release of B. pseudomallei. V. Methods for Surveillance: Surveillance for melioidosis should use the following recommended sources of data and the extent of coverage listed in Table V. Melioidosis case reports will derive from laboratory and clinician reporting to state and local health departments, which will conduct individual follow-up based on available resources. CDC will continue to provide national and international assistance/guidance upon request. Surveillance for melioidosis should use the source of data and the extent of coverage listed in Table V below. Table V. Recommended sources of data for case identification and extent of coverage for ascertaining cases of melioidosis. Page 2 of 10 Source of data for case ascertainment Clinician reporting Laboratory reporting Reporting by other entities (e.g., hospitals, veterinarians, pharmacies) Death certificates Hospital discharge or outpatient records Extracts from electronic medical records Telephone survey School-based survey Other Coverage Population-wide Sentinel sites x x x x x x VI. Criteria for case identification Reporting refers to the process of healthcare providers or institutions (e.g., clinical laboratories, hospitals) submitting basic information to governmental public health agencies about cases of illness that meet certain reporting requirements or criteria. The purpose of this section is to provide those criteria that should be used to determine whether a specific illness should be reported. A. Narrative description of criteria to determine whether a case should be reported to public health authorities Report any illness to public health authorities that meet any of the following criteria: Clinical criteria 1. A person with clinical evidence of systemic illness, pneumonia, or focal infection consistent with melioidosis, including one or more of the following: a. Fever >38C; b. Headache; c. Pneumonia; d. Myalgias; e. Anorexia; f. Chest pain, g. Skin abscess, h. Ulcer, i. Nodule, j. Respiratory distress, k. Abdominal discomfort, l. Joint pain, m. Abscess in the liver, spleen, or prostate n. Disorientation o. Weight loss p. Seizure Page 3 of 10 and one or more laboratory findings. 2. A person whose healthcare record contains a diagnosis of melioidosis. 3. A person whose death certificate lists melioidosis as a cause of death or a significant condition contributing to death. Laboratory criteria With or without clinical evidence (above): Isolation of B. pseudomallei from blood, sputum, urine, pus, throat swab, or swabs from organ abscesses or wound, or any other clinical source. Evidence of a fourfold or greater rise in B. pseudomallei antibody titer by IHA between acute- and convalescent-phase serum specimens obtained greater than or equal to 2 weeks apart. Detection of B. pseudomallei in a clinical specimen by nucleic acid amplification test. In association with clinical evidence (above); Melioidosis total antibody titer of greater than or equal to 1:40 by serology in one or more serum specimens obtained after onset of symptoms Epidemiologic evidence A person with acute febrile illness or skin lesion (abscess, nodule, ulcer) consistent with B. pseudomallei infection and one of the following findings History of travel to a region endemic for melioidosis Known exposure to B. pseudomallei as a result of intentional release or occupational risk (lab exposure). B. Table of criteria to determine whether a case should be reported to public health authorities: Table VI-B. Table of criteria to determine whether a case should be reported to public health authorities. Requirements for reporting are established under State and Territorial laws and/or regulations and may differ from jurisdiction to jurisdiction. These criteria are suggested as a standard approach to identify cases of this condition for purposes of reporting, but reporting should follow State and Territorial law/regulation if any conflicts occur between these criteria and those laws/regulations. Criterion Clinical Evidence Fever > 38.0C (100.4F) Headache Reporting O O O O Page 4 of 10 Pneumonia O O Myalgias O O Anorexia O O Chest pain O O Skin abscess O O Ulcer O O Nodule O O Respiratory distress O O Abdominal discomfort O O Joint pain O O Abscess in the liver, spleen or prostate O O Disorientation O O Weight loss O O Seizure O O A person whose healthcare record contains a S diagnosis of melioidosis Death certificate lists melioidosis as a cause S of death or a significant condition contributing to death Laboratory Evidence Isolation of B. pseudomallei from a clinical O S specimen such as blood, sputum, urine, pus, throat swab, or swabs from organ abscesses or wound Evidence of a fourfold or greater rise in B. O S pseudomallei antibody titer by IHA between acute- and convalescent-phase serum specimens obtained greater than or equal to 2 weeks apart. Detection of B. pseudomallei in a clinical O S specimen by nucleic acid amplification test Melioidosis total antibody titer of greater O than or equal to 1:40 by serology in one or more serum specimens obtained after onset of symptoms Epidemiologic Evidence History of travel to a melioidosis-endemic O region. Known exposure to B. pseudomallei as a O result of intentional release or lab exposures. Notes: S = This criterion alone is sufficient to report a case O = At least one of these “O” criteria in each category in the same column (e.g., clinical presentation and laboratory findings) is required to report a case. Page 5 of 10 C. Disease Specific Data Elements: Disease-specific data elements that should be included in the initial report are listed below Age, sex, geographic information Country of birth and length of time in the US (if not American-born) Clinical symptoms (mortality, severe manifestations) Hospitalization Date of onset Date of diagnosis Antimicrobial treatment Microbiological results Exposure Information: Specify contact type, date and location Military Service Microbiological laboratory work Travel information (especially travel to a melioidosis-endemic region) Soil or water contact especially during travel to a melioidosis-endemic region Animal (mammal, reptile, bird) contact Clinical risk factors for disease Diabetes Liver disease or chronic alcohol use Chronic renal disease Chronic lung disease Malignancy and other non HIV-related immune suppression Thalassemia VII. Case Definition for Case Classification A. Narrative description of criteria to determine how a case should be classified: Clinical description Clinical presentation of the disease varies on a case by case basis. The following characteristics are typical of melioidosis. An acute or chronic localized infection which may or may not include symptoms of fever and muscle aches. Such infection often results in ulcer, nodule, or skin abscess. An acute pulmonary infection with symptoms of high fever, headache, chest pain, anorexia, and general muscle soreness. A bloodstream infection with symptoms of fever, headache, respiratory distress, abdominal discomfort, joint pain, muscle tenderness, and/or disorientation. A disseminated infection with symptoms of fever, weight loss, stomach or chest pain, muscle or joint pain, and/or headache or seizure. Abscesses in the liver, lung, spleen, and prostate are often observed in patients diagnosed with disseminated infections; less frequently, brain abscesses may be seen. Page 6 of 10 Laboratory criteria for diagnosis Confirmed cases: Isolation of B. pseudomallei from a clinical specimen of a case of severe febrile illness: Culture of the organism may be done by blood, sputum, urine, pus, throat swab, or swabs from organ abscesses or wounds. Probable: Evidence of a fourfold or greater rise in B. pseudomallei antibody titer by IHA between acute- and convalescent-phase serum specimens obtained greater than or equal to 2 weeks apart. Evidence of B. pseudomallei DNA (for example, by LRN-validated polymerase chain reaction) in a clinical specimens collected from a normally sterile site (blood) or lesion of other affected tissue (abscesses, wound). Case Classification Probable: a case that meets the clinical case definition, one or more of the probable lab criteria, and one of the following epidemiologic findings: History of travel to a melioidosis-endemic region, or Known exposure to B. pseudomallei as a result of intentional release or occupational risk (lab exposure). Confirmed: a case that is laboratory confirmed, with or without clinical evidence. B. Classification Tables Table VII-B lists the criteria that must be met for a case to be classified as confirmed or probable/presumptive. Table VII-B. Table of criteria to determine whether a case is classified. Criterion Clinical Evidence Fever > 38.0C (100.4F Headache Pneumonia Myalgias Anorexia Chest pain Skin abscess Ulcer Nodule Respiratory distress Abdominal discomfort Case Definition Confirmed Probable O O O O O O O O O O O Page 7 of 10 Joint Pain O Abscess in the liver, spleen or prostate O Disorientation O Weight loss O Seizure O Laboratory Evidence Isolation of B. pseudomallei from a clinical specimen such as S blood, sputum, urine, pus, throat swab, or swabs from organ abscesses or wound Evidence of a fourfold or greater rise in B. pseudomallei O antibody titer between acute- and convalescent-phase serum specimens obtained greater than or equal to 2 weeks apart. Detection of B. pseudomallei in a clinical specimen by O nucleic acid amplification test Epidemiologic Evidence History of travel to a melioidosis-endemic region. O Known exposure to B. pseudomallei as a result of intentional O release or occupational risk (lab exposure). Notes: S = This criterion alone is sufficient to classify a case O = At least one of these “O” criteria in each category in the same column (e.g., clinical presentation and laboratory findings) is required to classify a case. VIII. Period of Surveillance Surveillance should be on-going. IX. Data sharing/release and print criteria States and territories will share data with CDC according to jurisdiction specific protocols. State-specific data on cases, if shared with CDC, will be verified prior to publication. X. References 1. Centers for Disease Control and Prevention. Imported Melioidosis --- South Florida, 2005. MMWR 2006; 55 (32): 873-876. Available from: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5532a1.htm 2. Centers for Disease Control and Prevention [Internet]. Melioidosis. Last updated: 2010 May 18. Accessed: 2010 Dec 28. Available from: http://www.cdc.gov/nczved/divisions/dfbmd/diseases/melioidosis/. 3. Centers for Disease Control and Prevention: Bioterrorism Agents/Diseases. Accessed: 2010 Dec 28. Available from: http://emergency.cdc.gov/agent/agentlist-category.asp. Page 8 of 10 4. Currie BJ, Ward L, Cheng AC, The epidemiology and clinical spectrum of melioidosis: 540 cases from the 20 year Darwin prospective study. PLoS Neglect Trop Dis 2010; 4(11): e900. 5. Dance DA. Melioidosis as an emerging global problem. Acta Trop 74 (2000) 115-119. 6. Dharakul T, Songsivilai S. Recent Developments in the Laboratory Diagnosis of Melioidosis. Journal of Infectious Diseases Antimicrobial Agents 1995; 13:77-80. 7. Hassan MR, Pani SP, et al. Incidence, risk factors and clinical epidemiology of melioidosis: a complex socio-ecological emerging infectious disease in the Alor Setar region of Kedah, Malaysia. BMC Infectious Diseases 2010, 10:302. 8. Inglis TJ, Sousa, AQ. The Public Health Implications of Melioidosis. The Brazilian Journal of Infectious Diseases 2009; 13(1):59-66. 9. International Health Regulations (2005) 2nd Edition. World Health Organization. Available from: http://www.who.int/ihr/9789241596664/en/index.html 10. Mandell GL, Bennett JE. (2005) Melioidosis. Principles and Practices of Infectious Diseases, 6th ed. Churchill Livingston: pp. 2625-2628. 11. Stewart T, Engelthaler DM, Blaney DD, Tuanyok A, Wangsness E, Smith TL, Pearson T, Komatsu K, Keim P, Currie B, Levy C, Sunenshine R. Epidemiology and Investigation of Melioidosis in Southern Arizona. EID. Accepted. XI. Coordination: Agencies for Response: (1) Dr. Thomas Frieden Director, Centers for Disease Control and Prevention 1600 Clifton Road, NE Atlanta, GA 30333 (404) 639-7000 TFrieden@cdc.gov Agencies for Information: (1) Dr. David Blaney Bacterial Special Pathogens Branch Division of High-Consequence Pathogens and Pathology Centers for Disease Control and Prevention, MailStop C09 1600 Clifton Road NE Atlanta, GA 30333 znr5@cdc.gov XII. Submitting Author: (1) James J. Gibson, MD, MPH Director, Bureau of Disease Control and State Epidemiologist South Carolina Department of Health and Environmental Control DHEC, Mills Building, 1751 Calhoun St. Columbia, SC 29201 (803) 898-0862 Page 9 of 10 gibsonjj@dhec.sc.gov Co-Authors: (1) Alfred DeMaria, Jr., M.D. Medical Director Bureau of Infectious Disease Prevention, Response and Services State Epidemiologist Massachusetts Department of Public Health William A. Hinton State Laboratory Institute 305 South Street Jamaica Plain, Massachusetts 02130 617-983-6550 Fax: 617-983-6925 Alfred.DeMaria@state.ma.us (2) Kenneth Komatsu State Epidemiologist Division of Public Health Services Arizona Department of Health Services 150 N. 18th Avenue, Suite 150 Phoenix, Arizona 85007 (602) 364-3587 (602) 542-2722 Fax (602) 725-1997 Cell komatsk@azdhs.gov Page 10 of 10