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NCT Number: NCT01170221

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 Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults.

Approximately 75 to 100 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 307, Avellaneda, Pcia Buenos Aires, Argentina

Loading trial locations.

About this study

The primary objective is to determine the noninferiority in the early clinical response rate of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72 Hour Visit in the ITT analysis set in patients with ABSSSI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (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

Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.

Other names: Tedizolid Phosphate, TR-700 active moiety

Linezolid

Drug

Oral Linezolid 600 mg twice daily for 10 days

Other names: Trade name = Zyvox, Generic name = linezolid

Primary outcomes

  1. Early Clinical Response Rate

    Time frame: 48-72 hours

    Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

Secondary outcomes

  1. Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.

    Time frame: Day 11

    Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.

  2. Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets

    Time frame: EOT Day 11

    Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

  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 most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, if present at baseline, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.

  4. To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the 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 most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.

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

    Time frame: 48-72 Hour Visit

    Clinical improvement was 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 was 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 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Acronym: ABSSSI

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2010
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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