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Tuberculosis (TB): Clinical Policies & Protocols 4th Edition March 2008 CLINICAL POLICIES AND PROTOCOLS Bureau of Tuberculosis Control New York City Department of Health and Mental Hygiene Abbreviations AAP American Academy of Pediatrics MAC mycobacterium avium complex ACH air changes per hour MAI mycobacterium avium intracellulare AFB acid-fast bacilli M. bovis mycobacterium bovis AII airborne infection isolation MDRTB multidrug-resistant tuberculosis ALT alanine transaminase MGIT Mycobacterial Growth Indicator Tube AMA against medical advice MIRU mycobacterial interspersal ANA antinuclear antibody repetitive units ATS American Thoracic Society MOTT mycobacterium other than BCG Bacille Calmette-Guérin tuberculosis, NTM BP base pairs MMR measles, mumps and/or rubella BTBC Bureau of Tuberculosis Control MRI magnetic resonance imaging CBC complete blood count M. tb mycobacterium tuberculosis ® CDC Centers for Disease Control MTD Mycobacterium Tuberculosis Direct and Prevention NAA nucleic acid amplification CDC/DGMQ CDC Division of Global Migration NIOSH National Institute for Occupational and Quarantine Safety and Health CFM cubic feet per minute NJMRC National Jewish Medical and CFP-10 culture filtrate protein-10 Research Center CI contact investigation NNRTIs non-nucleoside reverse transcriptase inhibitors CNS central nervous system NTM nontuberculosis mycobacterium, MOTT CSF cerebrospinal fluid NYCDOHMH New York City Department of Health CT computed tomography and Mental Hygiene CXR chest X-ray NYPHL New York City Bureau of Public DOS Department of State Health Laboratories DOT directly observed therapy PCR polymerase chain reaction DR direct repeat PHA public health advisor DRTB drug resistant tuberculosis PHI protected health information ECLRS Electronic Clinical Laboratory PIs protease inhibitors Reporting System PPD purified protein derivative EDN Electronic Disease Notification QFT-G QuantiFERON©-TB Gold EDTA ethylenediaminetetraacetic acid RFLP restriction fragment length ELISA enzyme-linked immunosorbent assay polymorphism ESAT-6 Early Secretory Antigenic Target-6 RTS return to supervision FP false-positive SDN Secure Data Network HAART highly active antiretroviral therapy SLE systemic lupus erythematosus HEPA high-efficiency particulate air SPC single positive culture HHS U.S. Department of Health and Human SSRIs selective serotonin reuptake inhibitors Services SST serum separator tubes HIPAA The Health Insurance Portability and TB tuberculosis Accountability Act of 1966 TDM therapeutic drug monitoring HIV Human Immunodeficiency Virus TI Technical Instructions for Medical IDPL Infectious Diseases Pharmacokinetics Examination of Aliens Laboratory TST tuberculin skin test IDSA Infectious Diseases Society of America TTBI test for tuberculosis infection INA Immigration and Naturalization Act UGVI ultraviolet germicidal irradiation IND investigational new drug ULN upper limits normal IFN-g interferon-gamma URF Universal Reporting Form IRIS immune reconstitution syndrome USCIS United States Citizenship and IRU Immigration and Refugee Unit Immigration Services LFTs liver function tests WHO World Health Organization LTBI latent tuberculosis infection XDRTB extremely drug resistant tuberculosis Clinical Policies and Protocols Bureau of Tuberculosis Control New York City Department of Health and Mental Hygiene 4th Edition March 2008 Content: Sonal S. Munsiff, MD Diana Nilsen, MD, RN Paula I. Fujiwara, MD, MPH Editorial: Cortnie Lowe, MFA, Executive Editor, Bureau of Communications Lise Millay Stevens, MA, Deputy Director, Editor Melissa Burdick Harmon, MA, Senior Editor Additional Contributions: Joseph Burzynski, MD, MPH Marie Dorsinville, RN, MPH Cynthia Driver, RN, DrPH Chrispin Kambili, MD Liza King, MPH Ann Winters, MD We thank the administrative staff at the BTBC Executive Office, especially Jasmine Hylton for her extensive administrative assistance, and all the BTBC and non-BTBC physicians and staff who read the manuscript and offered comments. www.nyc.gov/health/tb Table of Contents Section I. Section II. Introduction to the 4th Edition Initial Evaluation of Director’s Statement ...............................................11 Suspected Tuberculosis About the 4th Edition...............................................12 Pathogenesis of Tuberculosis ...............................25 The 2003 national guidelines..............................12 Transmission, infection and proliferation ....25 Rifapentine ....................................................... 12 Host immune response ...................................25 Use of fluoroquinolones Inflammation, necrosis and in the treatment of tuberculosis ..................13 cavity formation ...............................................25 BTBC guidelines vs. Physical Evaluation of Adults and Children .......26 ATS/CDC/IDSA guidelines.............................13 Radiographic Evaluation........................................27 Treatment of patients who are co-infected with tuberculosis and HIV...............................14 Microbiologic Evaluation ......................................27 Hospitalization and discharge guidelines....14 Specimen collection ........................................27 Targeted testing and Nucleic acid amplification ............................30 latent tuberculosis infection .........................15 Culture ................................................................31 Key sources........................................................15 Species identification .....................................32 Appendices ........................................................15 Drug susceptibility testing ............................32 Tuberculosis Surveillance and Epidemiology.......15 Genotyping ........................................................34 Surveillance.........................................................15 False-positive results......................................35 Tuberculosis epidemiology Objectives of false-positive in New York City.............................................. 16 M. tb specimen investigations......................35 Methods used to identify Confidentiality and Health Insurance Portability false-positive M. tb cultures..........................35 and Accountability Act Regulations ....................16 Interpreting results of the Laws governing confidentiality ....................16 false-positive investigation ............................36 HIPAA privacy rule ..........................................17 Other Laboratory Tests............................................36 Talking to tuberculosis patients and contacts ......................................................18 Classification of Suspected Tuberculosis Patients .............................................36 Exceptions to confidentiality rules..............18 Tuberculosis in Childhood .....................................37 Mission Statement ..................................................20 Medical evaluation..........................................37 Key Sources .............................................................21 Chest X-ray in children ..................................37 Congenital and neonatal tuberculosis ......38 Evaluating neonates for tuberculosis.........38 Bacille Calmette-Guérin vaccination.........38 Key Sources .............................................................40 New York City Department of Health and Mental Hygiene 1 Table of Contents Section III. Regimens for Patients Treatment of Pulmonary Tuberculosis with Chronic Renal Failure....................................60 Regimens for Treatment of Regimens for Patients with Liver Disease..........61 Drug-Susceptible Tuberculosis ............................43 The Use of Pyridoxine (Vitamin B6) Standard regimen .............................................43 in Tuberculosis Treatment......................................62 Length of treatment ..........................................43 Anti-Tuberculosis Drugs and Meals ....................62 Intermittent Regimens ............................................44 Directly Observed Therapy ....................................63 Rifapentine ...............................................................46 Protocol for providing Patient selection...............................................46 directly observed therapy..............................63 Treatment length..............................................48 Priority of patients for directly observed therapy..............................64 Dosing .................................................................48 Monitoring..........................................................48 Determination of Treatment Completion..............64 Adverse reactions ............................................48 Interrupted or incomplete treatment...........65 Use in pregnant and Renewal of tuberculosis treatment .............65 breast-feeding women....................................48 Continuation of lapsed treatment ...............65 Use in children..................................................48 Protocols for reinstituting treatment...........65 Drug interactions .............................................48 Treatment failure..............................................67 Treatment of Co-existent Tuberculosis and HIV ....49 Treatment of coexistent tuberculosis Antiretroviral drugs and rifamycins ...........49 and disseminated Mycobacterium Treatment options ............................................52 avium-intracellulare .......................................67 General considerations..................................52
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