Using Xpert to discontinue airborne isolation The Consensus Statement

Transcription

1 Using Xpert to discontinue airborne isolation The Consensus Statement Neha Shah, MD MPH Tuberculosis Control California Department of Public Health Centers for Disease Control and Prevention NAR February 2017

2 Disclosures No affiliation or financial relationship with any of the tests or companies mentioned in this presentation This presentation does not necessarily represent the official position of the US Centers for Disease Control and Prevention

3 guidelines 3

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5 Removing Patients from A.I.I. Infectious TB disease is considered unlikely AND EITHER another diagnosis explains the clinical syndrome OR 3 consecutive, negative sputum smears with at least one is an early morning specimen For negative sputum smear results, release from A.I.I in 2 days. 5

6 Removing Patients from A.I.I. Traditionally 3 sputum smears collected early morning on 3 consecutive days Took a long time: average 5-7 days in isolation Not sensitive 50-60% Not specific 70-90% (depending on NTM and TB prevalence) Abad et. al. J of Hosp Infection 2010:97; Swai et al. BMC Research Notes (475); Cattamanchi et al. BMC Infect Dis. 2009; 9: 53. Singhal et al. Intl J of Mycobacteriology 2015: 4 (1)

7 Problems with Isolation Limited number of A.I.I. rooms Systemic review showed patients in isolation tend to: Be seen less by HCWs Have an 8 fold increase in adverse effects Have a negative perspective of their care* Delay in getting the proper procedure performed *Abad et. al. J of Hosp Infection 2010:97

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9 Luetkemeyer Clin Infect Dis May 1;62(9) 9

10 Luetkemeyer Clin Infect Dis May 1;62(9) 10

11 Luetkemeyer Clin Infect Dis May 1;62(9) 11

12 Luetkemeyer Clin Infect Dis May 1;62(9) 12

13 Summary ACTG trial Overall Smear positive Smear Negative NPV 1 Xpert 85.2% 96.7% 59.3% 99.7% 2 Xperts 91.1% 100% 71.4% 100% 13

14 Campos, Am J Respir Crit Care Med Aug 1;178(3 14

15 Campos, Am J Respir Crit Care Med Aug 1;178(3 15

16 Chaisson CID 2014: 59 16

17 Chaisson CID 2014: 59 17

18 Lippincott, Clin Infect Dis Jul 15;59(2): 18

19 Lippincott, Clin Infect Dis Jul 15;59(2): 19

20 Lippincott, Clin Infect Dis Jul 15;59(2): 20

21 Lippincott, Clin Infect Dis Jul 15;59(2): 21

22 Summary of trial data Improved sensitivity and specificity of NAA versus sputum AFB smear Cost savings by reducing time in A.I.I. and length of hospital stay * Luetkemeyer, et al. ACTG and TBTC. Clin Infect Dis. epub 2/2/2016

23 FDA Response 23

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25 FDA Approval of Xpert for A.I.I. Either one or two sputum specimens can be used as an alternative to examination of serial acid-fast stained sputum smears to aid in the decision to discontinue A.I.I. for patients with suspected pulmonary TB

26 Purpose: To provide guidance on the use of the Xpert to discontinue airborne infection isolation (A.I.I.) for persons with suspected, infectious pulmonary tuberculosis (TB)

27 Consensus Statement IS DOES NOT ADDRESS The diagnosis of TB When a TB case/suspect can be released from the hospital IT IS To help predict infectiousness To help determine clinical appropriateness to be removed from isolation 27

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29 Case 1 91 year old male from Philippines Remote history of TB per patient Hemoptysis but no other TB symptoms Xpert positive Discontinue Isolation? 29

30 Case 1 30

31 Case 2 18 year old male from China IGRA negative CXR with LUL calcification consistent with granuloma disease Xpert negative 31

32 Case 2 32

33 Case 2 Second Xpert negative 33

34 Case 2 34

35 Case 2 18 year old male from China IGRA negative CXR with LUL calcification consistent with granuloma disease Xpert negative x 2 35

36 Case 3 18 year old male from China IGRA positive CXR with LUL calcification consistent with granuloma disease Nonproductive cough Xpert negative 36

37 Case 3 37

38 Case 3 Second Xpert negative 38

39 Case 3 39

40 Case 3 Discontinue isolation? 18 year old from China IGRA positive What if he had hemoptysis instead of dry cough? CXR with LUL calcification consistent with granuloma disease Dry cough What if it was winter time and everyone in dorm had a cough? What if he was smear positive? 40

41 Case 3 41

42 Case 3 Discontinue isolation? REPORT TO HEALTH DEPARTMENT 42

43 Case 4 40 year US-born individual TST positive Had minimal contact to TB case Nonproductive cough CXR: minimal infiltrates RML Xpert negative 43

44 Case 4 44

45 Case 4 Second Xpert positive 45

46 Case 4 46

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52 Infectiousness Coughing Cavity in the lung TB disease of the lungs, airway, or larynx Undergoing cough-inducing or aerosolgenerating procedures Not receiving adequate therapy

53 Xpert and A.I.I. Labelling Change: Operational Considerations Communication and coordination between clinicians and patient service providers are essential Nursing Respiratory Therapy Medical providers Laboratory IT / reporting platforms Institutional Infection Control

54 In The END, This Is Just The Beginning Data Collection and Analysis Infection Control programs should collaborate with the TB Laboratory and public health to collect and analyze data to evaluate the effectiveness methods used to determine discharge from A.I.I. Periodic analysis of protocol performance should be used to improve and/or modify policies and procedures

55 Summary Historically 3 smears used to determine discontinue of AII Can now use Xpert Consensus statement developed to assist with determining criteria to discontinue isolation 55

56 Summary DO NOT use consensus statement as a diagnostic algorithm If smells like TB, it is still TB Keep public health TB program aware of any suspected TB cases 56

57 Acknowledgements NAAT National Tuberculosis Controllers Association California Tuberculosis Control Slides borrowed from John Bernardo and Dave Ashkin The Consensus Committee 57