ADJUVANT TIGECYCLINE FOR SEVERE CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA

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1 ADJUVANT TIGECYCLINE FOR SEVERE CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA Candace Marr, DO Catholic Health System University at Buffalo, NY Kevin Shiley, MD Catholic Health System Buffalo, NY

2 FINANCIAL DISCLOSURES None

3 BACKGROUND Tigecycline is a broad-spectrum glycilcycline antibiotic first FDA-approved in 2005 for treatment of complicated skin and soft-tissue infections and complicated intra-abdominal infections Tigecycline inhibits Clostridium difficile toxin production and sporulation in vitro Tigecycline has been used off-label for treatment of refractory or severe CDAD In September of 2013, the FDA issued a warning regarding increased risk of death when tigecycline was used for treatment of FDA-approved or nonapproved uses Baines et al. Journal of Antimicrobial Chemotherapy (2006) 58,

4 METHODS: STUDY DESIGN Multicenter, retrospective cohort study at two university-affiliated hospitals in Buffalo, NY 200 bed community hospital and 320 bed tertiary care center 36,172 discharges per year combined All patients who were treated for Clostridium difficile diarrhea from January 1 st, 2011 to December 31 st, 2013 were evaluated according to their severity of illness. Severe CDAD was defined by a scoring system derived from the Hines VA Clostridium difficile severity index score. Patients with a score of 3 or greater were included in the study.

5 METHODS: IDENTIFICATION OF SEVERE CDI Documented fever 38 C within 3 days of diagnosis: 1 point Hypotension (systolic blood pressure <100 mm Hg on any single read within 3 days of diagnosis): 1 point Leukocytosis WBC 15,000, <30,000: 1 point WBC 30,000: 2 points ICU admission: 1 point

6 MORTALITY AND CDAD SCORE CDI score 1-2 <5% 3 31% 4 49% 5 60% In-hospital Mortality Rate 70% 60% 50% 40% 30% In-hospital mortality vs CDI severity score 20% 10% 0%

7 IDENTIFICATION OF SEVERE CDI The ATLAS score, a prospectively validated bedside scoring system for CDI severity, was also collected for each patient 0 points 1 point 2 points Age <60 years years 80 years Temperature < 37.5 o C o C > 38.6 o C Leukocytosis < 16,000 16,000 > 25,000 25,000 Albumin (g/l) > < 25 Systemic concomitant antibiotics No - Yes

8 METHODS: OUTCOME MEASURES AND ANALYSIS Primary end-point: All cause 30 day mortality. Secondary end-points: all-cause, in-hospital mortality colectomy as treatment for C. difficile The primary end-point was compared by binary logistic regression analysis with CDAD severity score and tigecycline exposure as covariates

9 646 patients with CDAD 560 had severity score <3 7 met exclusion criteria 79 had severity score 3 33 tigecycline 46 standard therapy 20 died (61%) 2 with< 48 hrs of tigecycline 16 died (35%) 30 discharged alive (65%) 11 discharged alive (35%)

10 PATIENT CHARACTERISTICS Adjuvant Tigecycline Group N=31 Standard Therapy Group N=46 P value Age (mean, st dev) 74, 11 72, Acute kidney injury (%) 17 (55) 23 (50) 0.82 Hypoalbuminemia (<2.5g/L), (%) 20 (65) 31 (67) 0.81 Concurrent non-cdad antimicrobial 12 (39) 18 (39) 1.00 therapy (%) Concurrent steroid therapy (%) 10 (32) 11 (24) 0.45

11 C. DIFFICILE THERAPIES Adjuvant Tigecycline Group N=31 Standard Therapy Group N=46 P value Metronidazole (%) 31 (100) 43 (93) 0.27 PO Vancomycin (%) 25 (74) 33 (72) 0.43 PO Vancomycin + 26 (84) 31 (67) 0.12 Metronidazole (%) Fidaxamicin (%) 8 (26) 6 (13) 0.23

12 CLINICAL CHARACTERISTICS Adjuvant Tigecycline Group N=31 Standard Therapy Group N=46 P value Hypotension (%) 21 (94) 41 (89) WBC 15 (%) 31 (100) 46 (100) Fever (%) 17 (55) 34 (74) ICU (%) 28 (90) 24 (52) CDAD severity score (mean, st dev) 4.06, , ATLAS score 7.19 (SD 1.47) 6.72 (SD 1.43) 0.168

13 RESULTS: OUTCOMES Outcome Measure Adjuvant Tigecycline n=46 Standard Therapy N=31 Adjusted OR (95% CI) Adjusted P 30 day Mortality* 14 (30.4) 16 (51.6) 2.89 ( ) (%) In Hospital 15 (32.6) 19 (61.3) 2.77 ( ) Mortality (%) Colectomy (%) 1 (2.17) 7 (22.6) 11.3 ( ) *5 patients discharged in stable condition prior to 30 days were lost to follow up

14 TIGECYCLINE TIMING 70% of patients were prescribed Tigecycline within 48 hours of diagnosis There was higher mortality in the late therapy group, but the difference was not significant (0.70 vs 0.52, p = 0.45)

15 LIMITATIONS Retrospective nature Sample Size C. difficile assay did not identify NAP1 strains

16 DISCUSSION Adjunctive therapy with tigecycline was associated with higher mortality and colectomy rates Despite tigecycline s in vitro activity against C. difficile, its broad spectrum activity may contribute to continued dysregulation of gut flora and promotion of a C. difficile-susceptible gut environment Tigecycline use for non-cdad infections was previously associated with higher adverse events and clinical failure rates when compared to other antimicrobial therapies It is possible that one or more of these processes may have contributed to the increased mortality rate in this study s tigecycline cohort. A larger multicenter study may help better elucidate potential adverse outcomes related to tigecycline among severe CDAD patients. Cai Y, Wang R, Liang B, et al. Systematic review and meta-analysis of the effectiveness and safety of tigecycline for treatment of infectious disease. Antimicrob Agents Chemother 2011; 55:

17 REFERENCES 1 Jump RL, Li Y, Pultz MJ, Kypriotakis G, Donskey CJ. Tigecycline exhibits inhibitory activity against Clostridium difficile in the colon of mice and does not promote growth or toxin production. Antimicrob Agents Chemother. 2011;55(2): Aldape MJ, Heeney DD, Bryant AE, Stevens DL. Tigecycline suppresses toxin A and B production and sporulation in Clostridium difficile. J Antimicrob Chemother. 2015;70(1): Herpers BL, Vlaminckx B, Burkhardt O, et al. Intravenous tigecycline as adjunctive or alternative therapy for severe refractory Clostridium difficile infection. Clin Infect Dis. 2009;48(12): Lao D, Chiang T, Gomez E. Refractory Clostridium difficile Infection Successfully Treated with Tigecycline, Rifaximin, and Vancomycin. Case Rep Med. 2012;2012: Fujitani S, George WL, Murthy AR. Comparison of clinical severity score indices for Clostridium difficile infection. Infect Control Hosp Epidemiol. 2011;32(3): Cai Y, Wang R, Liang B, et al. Systematic review and meta-analysis of the effectiveness and safety of tigecycline for treatment of infectious disease. Antimicrob Agents Chemother 2011; 55: Food and Drug Administration.Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death. FDA.gov. 27 September Available at Accessed 6 April HERNANDEZ-ROCHA, Cristian et al. Performance of prognostic index in severe Clostridium difficile-associated infection: Retrospective analysis in a university hospital.rev. chil. infectol. [online]. 2014, vol.31, n.6 [cited ], pp Available from: < ISSN

18 QUESTIONS?

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