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Post-Hoc Evaluation of Antibiotic Therapy Length for Complicated Intra-Abdominal Infections

This study evaluates the duration of antibiotic therapy for complicated intra-abdominal infections and identifies patient- or disease-related factors associated with shorter treatment courses. The analysis focuses on the results of a phase 3 trial comparing eravacycline and meropenem. The study demonstrates that sicker patients and those with non-appendiceal diagnoses or who undergo open surgical procedures tend to receive longer courses of antibiotic treatment.

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Post-Hoc Evaluation of Antibiotic Therapy Length for Complicated Intra-Abdominal Infections

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  1. A post-hoc evaluation of the length of antibiotic therapy from IGNITE4: A phase 3 study of eravacycline and meropenem for complicated intra-abdominal infections Kenneth Lawrence1, Erin Mathias2, Melanie Olesky1, Ekaterina Efimova1 , Larry Tsai1 ,Philip S. Barie3 1Tetraphase Pharmaceuticals, Watertown, MA 2Veristat, Southborough, MA 3Weill Cornell Medicine, New York, NY

  2. Disclosures • KL, MO, EE are employees of Tetraphase Pharmaceuticals • EM is an employee of Veristat • PSB no financial relationships SIS 38th Annual Meeting 2018

  3. Background • Eravacycline is a novel, fully-synthetic fluorocycline antibiotic that has completed phase 3 clinical development for patients with cIAI. • In IGNITE1 and IGNITE4, IV eravacycline met the primary endpoint of non-inferiority of clinical response compared to ertapenem and meropenem, respectively, and was generally well tolerated. • This analysis was performed to assess prescribing of antibiotic therapy for cIAI subsequent to STOP-IT with respect to duration, and to determine patient- or disease-related characteristics related to shorter treatment courses, regardless of patient severity of illness. SIS 38th Annual Meeting 2018 Sawyer et al. N Engl J Med 2015;372:1996-2005

  4. Methods • IGNITE4 was a double-blind, inferiority phase 3 trial in which patients with documented cIAI were randomized (1:1) to receive either eravacycline or meropenem for 4-14 days (d). • Three groups were categorized based on duration of treatment: < 5 d, 5.5 to 8 d, and > 8 d. • Statistical analysis assessed the association of several collected patient variables using multi-group Χ2 to compare data among groups (p < 0.05). • Ordinal logistic regression was performed with all variables having a univariate association with duration of therapy. Tsai L, et al. 28th ECCMID Madrid, Spain. O0421 SIS 38th Annual Meeting 2018

  5. Results • Patients who received longer duration of therapy had the following: • APACHE II score ≥ 10 • Less likely to have a diagnosis of complicated appendicitis • More likely to have an open surgical procedure • APACHE II score ≥ 10 was not significant after adjusting for diagnosis and open surgical procedure. • Average duration of therapy for all patients was 7.4 d, and for the groups were 4.6 d, 7.2 d, and 12.3 d, respectively. • Clinical successes in the micro-ITT group for the three groups were 88.4%, 94.5%, and 87.0%, respectively. SIS 38th Annual Meeting 2018

  6. Results SIS 38th Annual Meeting 2018 [1] p-value from chi-square test for univariate associations

  7. Results [1] Odds ratio and 95% confidence interval (CI) from an ordinal logistic regression model containing all characteristics having a significant univariate association with DoRx SIS 38th Annual Meeting 2018

  8. Conclusions • In IGNITE4, patients receiving longer courses of antibiotic treatment were sicker, had a non appendiceal diagnosis, and were more likely to have an open surgical procedure. • Compared to IGNITE1, fewer patient- and disease-related characteristics were associated with longer duration of treatment in IGNITE4. • Non appendiceal diagnosis and open surgical procedure were significantly associated with longer treatment duration in both IGNITE1 and IGNITE4. • Average duration of treatment exceeded that in the short-course treatment group in STOP-IT and were similar to those in IGNITE1. SIS 38th Annual Meeting 2018 Hoffman-Roberts HL, et al. 36th SIS Annual Meeting 2016

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