Program Schedule

Effect of NSAID/Corticosteroid Use on the Efficacy of Tedizolid in Acute Bacterial Skin and Skin Structure Infections: Pooled Data From the Phase 3 ESTABLISH-1 and ESTABLISH-2 Studies

Session: Poster Abstract Session: Antimicrobial Resistance: Novel Agents and Approaches to Gram-positive Infections
Thursday, October 9, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
  • 150100334-03 ID Week Poster_NSAID_L2_100614_FINAL.pdf (733.7 kB)
  • Background:

    Tedizolid (TZD) is a novel oxazolidinone with potent activity against a wide range of Gram-positive pathogens, including MRSA, and with a favorable safety profile. In two Phase 3 trials, ESTABLISH-1 and ESTABLISH-2, TZD (200 mg once daily for 6 d) demonstrated noninferiority  to linezolid (LZD) (600 mg twice daily for 10 d) in patients with acute bacterial skin and skin structure infections (ABSSSI). Use of non-steroidal anti-inflammatory drugs (NSAID) and/or corticosteroids (CS) is common in patients with ABSSSI. Due to their anti-inflammatory properties, it is possible that concomitant use of these agents may reduce lesion size and confound the primary outcome of ≥20% reduction in lesion size at the 48−72 hour visit. This subgroup analysis of pooled data from ESTABLISH-1 and -2 examined the effect of concomitant NSAID/CS use on early clinical response in patients with ABSSSI receiving TZD or LZD.


    Patients with ABSSSI (lesion surface area ≥75 cm2 and ≥1 regional or systemic sign of infection) received TZD 200 mg qd for 6 days or LZD 600 mg bid for 10 days. The use of NSAIDS/CS was documented for each patient and the primary outcome for both therapies at the 48-72 h visit was measured with/without NSAID/CS use.

    Results: A total of 1333 patients were randomly assigned to TZD or LZD. Patients were mostly male (63.1%); average age of 44 y. The most common ABSSSI was cellulitis (45.3% and 45.9% in TZD and LZD treatment groups, respectively), followed by major cutaneous abscess (25.3% and 24.8%), and wound infections (29.4% and 29.3%). Overall, 44 of 664 patients (6.6%) in the TZD treatment group and 63 of 669 patients (9.4%) in the LZD group received NSAID or oral CS during the first 72 hours of treatment. Among patients receiving NSAID/CS, early clinical response rates at the 48-72 h visit were similar between TZD and LZD groups (70.5% vs 69.8%), but lower overall than compared with patients not receiving NSAID/CS (82.4% with TZD vs 80.4% with LZD).


    Early clinical response rates were similar in patients treated with either TZD or LZD for ABSSSI in the ESTABLISH-1 and -2 trials, regardless of NSAID/CS use.  This finding suggests there is an absence of bias with anti-inflammatory use in assessing early clinical response rates in ABSSSI clinical trials.

    Taylor Sandison1, Carisa De Anda1, Anita Das2 and Philippe Prokocimer1, (1)Cubist, San Diego, CA, (2)InClin, San Mateo, CA


    T. Sandison, Cubist: Employee, Salary

    C. De Anda, Cubit: Employee and Shareholder, Salary

    A. Das, Cubist: Consultant, Consulting fee
    Cempra: Consultant, Consulting fee
    Cerexa: Consultant, Consulting fee
    Nabriva: Consultant, Consulting fee
    Paratek: Consultant, Consulting fee
    Trius: Consultant, Consulting fee
    Achaogen: Consultant, Consulting fee
    Durata: Consultant, Consulting fee

    P. Prokocimer, Cubist: Employee and Shareholder, Salary

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