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NCT Number: NCT01421511

TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment with at least 2 IV doses and may receive IV therapy for the entire treatment duration.

Approximately 100 to 140 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment.

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Key information

Conditions

Skin and Subcutaneous Tissue Bacterial Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Trius investigator site 352, Cludadela, Buenos Aires, Argentina

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About this study

The primary objective is to determine the noninferiority (NI) in the early clinical response rate of intravenous (IV) to oral 6 day TR-701 free acid (FA) compared with that of IV to oral 10-day linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with ABSSSI.
  • Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Exclusion criteria

  • Uncomplicated skin infections
  • Severe sepsis or septic shock
  • ABSSSI solely due to gram-negative pathogens

Treatment and study plan

TR-701 FA

Drug
  • TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion
  • TR-701 FA Tablets, 200 mg, orally once daily

Linezolid

Drug
  • Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion
  • Linezolid Tablets, 600 mg, orally every 12 hours

Primary outcomes

  1. The Early Clinical Response Rate

    Time frame: 48-72 hours

    Responder: No increase in lesion surface area from baseline.

Secondary outcomes

  1. Clinical Response at the End of Therapy Visit

    Time frame: Day 11

    Responder: No increase in lesion surface area from baseline.

  2. Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set

    Time frame: End of Therapy Day 11

    Responder: No increase in lesion surface area from baseline.

  3. Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit

    Time frame: Post-Treatment Evaluation (7-14 days after the End of Therapy)

    Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, and no further antibiotic therapy required for treatment of primary ABSSSI lesion.

  4. Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.

    Time frame: Post-Treatment Evaluation (7-14 days after the End of Therapy)

    Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, no new signs, symptoms or complications attributable to the ABSSSI and no further antibiotic therapy required for treatment of primary ABSSSI lesion.

  5. Investigator's Assessment of Clinical Response at the 48-72 Hour Visit

    Time frame: 48-72 Hours

    Clinical improvement defined as improvement in overall clinical status.

  6. Investigator's Assessment of Clinical Response at the Day-7 Visit

    Time frame: Day 7

    Clinical improvement defined as improvement in overall clinical status.

  7. Change From Baseline in Patient-reported Pain, by Study Visit

    Time frame: Multiple

    0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.

Sponsors and collaborators

Lead sponsor

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study title

A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of IV to Oral 6-Day TR-701 Free Acid and IV to Oral 10-Day Linezolid for the Treatment of ABSSSI

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 22, 2011
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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