A Phase 3 interventional study of TR-701 FA and Linezolid in Skin and Subcutaneous Tissue Bacterial Infections, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Completed at 84 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (part of Merck & Co., Inc) · Phase 3, Interventional, and Treatment
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
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.
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 19 studies on the registry; none are open to participants now.
First submitted before Trius Therapeutics LLC became part of Merck & Co., Inc.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo
Drug: TR-701 FA
Linezolid 600 mg tablets oral twice a day for 10 days
Drug: Linezolid
Early Clinical Response Rate
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
Time frame: 48-72 hours
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.
Time frame: Day 11
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
Time frame: EOT Day 11
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
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.
Time frame: Post-Treatment Evaluation (7-14 days after the End of Therapy)
To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set
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.
Time frame: Post-Treatment Evaluation (7-14 days after the End of Therapy)
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit
Clinical improvement was defined as improvement in overall clinical status.
Time frame: 48-72 Hour Visit
Investigator's Assessment of Clinical Response at the Day 7 Visit
Clinical improvement was defined as improvement in overall clinical status.
Time frame: Day 7
Change From Baseline in Patient-reported Pain, by Study Visit
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.
Time frame: Multiple
| Milestone | Tedizolid Phosphate | Linezolid |
|---|---|---|
| Started | 332 | 335 |
| Completed | 299 | 307 |
| Not completed | 33 | 28 |
| Withdrew: Lost to follow-up | 22 | 21 |
| Withdrew: Withdrawal by subject | 9 | 7 |
| Withdrew: Subject completed only screening and lfu | 1 | 0 |
| Withdrew: Randomized but not treated | 1 | 0 |
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
| Responders | Tedizolid Phosphate | Linezolid |
|---|---|---|
| Early Clinical Response Rate | 264 (-6.1 to 6.2) | 266 (-6.1 to 6.2) |
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.
| participants | Tedizolid Phosphate | Linezolid |
|---|---|---|
| Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit. | 230 | 241 |
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
| participants | Tedizolid Phosphate | Linezolid |
|---|---|---|
| Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets | 219 | 232 |
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.
| participants | Tedizolid Phosphate | Linezolid |
|---|---|---|
| Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit | 284 | 288 |
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.
| participants | Tedizolid Phosphate | Linezolid |
|---|---|---|
| To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set | 264 | 267 |
Clinical improvement was defined as improvement in overall clinical status.
| participants | Tedizolid Phosphate | Linezolid |
|---|---|---|
| Investigator's Assessment of Clinical Response at the 48-72 Hour Visit | 299 | 290 |
Clinical improvement was defined as improvement in overall clinical status.
| participants | Tedizolid Phosphate | Linezolid |
|---|---|---|
| Investigator's Assessment of Clinical Response at the Day 7 Visit | 302 | 299 |
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.
| units on a scale | Tedizolid Phosphate | Linezolid |
|---|---|---|
| Day 2 | -1.3 ± 2.05 | -1.5 ± 1.99 |
| Day 4-6 | -3.4 ± 2.44 | -3.1 ± 2.41 |
| Day 7-9 | -4.5 ± 2.71 | -4.6 ± 2.67 |
| Day 10-13 | -5.3 ± 2.65 | -5.5 ± 2.58 |
Collected over Collected from signing of the ICF through the late follow-up visit (up to 38 days).. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tedizolid Phosphate | — | 5/331 (1.5%) | 84/331 (25.4%) |
| Linezolid | — | 4/335 (1.2%) | 100/335 (29.9%) |
| Event | Tedizolid Phosphate | Linezolid |
|---|---|---|
| Cardiac arrestCardiac disorders | 1/331 | 0/335 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/331 | 0/335 |
| VomitingGastrointestinal disorders | 1/331 | 0/335 |
| AbscessInfections and infestations | 1/331 | 0/335 |
| EndophthalmitisInfections and infestations | 1/331 | 0/335 |
| PneumoniaInfections and infestations | 1/331 | 0/335 |
| Septic shockInfections and infestations | 1/331 | 0/335 |
| Weight decreasedInvestigations | 1/331 | 0/335 |
| DehydrationMetabolism and nutrition disorders | 1/331 | 0/335 |
| VIIth nerve paralysisNervous system disorders | 1/331 | 0/335 |
| Event | Tedizolid Phosphate | Linezolid |
|---|---|---|
| NauseaGastrointestinal disorders | 28/331 | 45/335 |
| HeadacheNervous system disorders | 21/331 | 17/335 |
| VomitingGastrointestinal disorders | 9/331 | 20/335 |
| DiarrheaGastrointestinal disorders | 15/331 | 18/335 |
| AbscessInfections and infestations | 14/331 | 8/335 |
| Abscess limbInfections and infestations | 12/331 | 10/335 |
| CellulitisInfections and infestations | 8/331 | 8/335 |
| DizzinessNervous system disorders | 8/331 | 7/335 |
| PruritusSkin and subcutaneous tissue disorders | 3/331 | 8/335 |
| DyspepsiaGastrointestinal disorders | 2/331 | 7/335 |
All randomized participants
| Age, Continuous(Years) | Tedizolid Phosphate | Linezolid | Total |
|---|---|---|---|
| Mean | 43.6 ± 14.96 | 43.1 ± 15.06 | 43.3 ± 15.0 |
| Sex: Female, Male(Participants) | Tedizolid Phosphate | Linezolid | Total |
|---|---|---|---|
| Female | 128 | 137 | 265 |
| Male | 204 | 198 | 402 |
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Aug 2010 to primary completion in Sep 2011, 13 months.
Results were first posted in Sep 2014, 2 years 11 months after primary completion. A results delay was requested in Apr 2014.
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Studies of the drug tested here: Tedizolid phosphate
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) →