A Phase 2 interventional study of TR-701 200 mg and TR-701 300 mg in Skin Diseases, Infectious and Skin Diseases, Bacterial, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Completed at 12 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-25.
Sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Phase 2, Interventional, and Treatment
The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with complicated skin and skin structure infections.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 192 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: TR-701 200 mg
Drug: TR-701 300 mg
Drug: TR-701 400 mg
oral TR-701 200 mg for 5 to 7 days
oral TR-701 300 mg for 5 to 7 days
TR-701 400 mg for 5 to 7 days
Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Time frame: 7 to 14 days after the last dose of study drug
Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Time frame: 7-14 days after last dose of study drug
Response Rate at End of Therapy
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Time frame: last day of study treatment
Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set
Satisfactory microbiological outcomes are eradication and presumed eradication
Time frame: 7-14 days after last dose of study drug
Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set
Persistent clinical cure was defined as continuing favorable response.
Time frame: 21 to 28 days after the last study drug
To Evaluate the Safety Profile of Tedizolid Phosphate
Time frame: Multiple
Population PK
Time frame: Multiple
Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set
Time frame: 21-28 days after last study drug
| Milestone | TR-701 200 mg | TR-701 300 mg | TR-701 400 mg |
|---|---|---|---|
| Started | 64 | 64 | 64 |
| Completed | 55 | 60 | 56 |
| Not completed | 9 | 4 | 8 |
| Withdrew: Randomized but didn't receive drug | 1 | 1 | 2 |
| Withdrew: Lost to follow-up | 6 | 3 | 6 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Bacteremia | 1 | 0 | 0 |
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
| Percentage of participants | TR-701 200 mg | TR-701 300 mg | TR-701 400 mg |
|---|---|---|---|
| Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set | 98.2 (90.4 to 100) | 94.4 (84.6 to 98.8) | 94.4 (84.6 to 98.8) |
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
| Percentage of participants | TR-701 200 mg | TR-701 300 mg | TR-701 400 mg |
|---|---|---|---|
| Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set | 88.9 (78.4 to 95.4) | 88.9 (78.4 to 95.4) | 85.5 (74.2 to 93.1) |
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
| Percentage of participants | TR-701 200 mg | TR-701 300 mg | TR-701 400 mg |
|---|---|---|---|
| Response Rate at End of Therapy | 93.7 (84.5 to 98.2) | 90.5 (80.4 to 96.4) | 91.9 (82.2 to 97.3) |
Satisfactory microbiological outcomes are eradication and presumed eradication
| Percentage of participants | TR-701 200 mg | TR-701 300 mg | TR-701 400 mg |
|---|---|---|---|
| Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set | 100 (91.8 to 100) | 93.2 (81.3 to 98.6) | 100 (92.3 to 100.0) |
Persistent clinical cure was defined as continuing favorable response.
| Percentage of Participants | TR-701 200 mg | TR-701 300 mg | TR-701 400 mg |
|---|---|---|---|
| Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set | 96.4 | 98.2 | 98.1 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
| Percentage of participants | TR-701 200 mg | TR-701 300 mg | TR-701 400 mg |
|---|---|---|---|
| Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set | 0 (0 to 6.4) | 0 (0 to 6.4) | 0 (0 to 6.7) |
Collected over Adverse events were to be collected after informed consent through last visit (up to 36 days).. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TR-701 200 mg | — | 2/63 (3.2%) | 40/63 (63.5%) |
| TR-701 300 mg | — | 1/63 (1.6%) | 44/63 (69.8%) |
| TR-701 400 mg | — | 2/62 (3.2%) | 43/62 (69.4%) |
| Event | TR-701 200 mg | TR-701 300 mg | TR-701 400 mg |
|---|---|---|---|
| Suicidal ideationPsychiatric disorders | 0/63 | 0/63 | 1/62 |
| AbcessInfections and infestations | 1/63 | 0/63 | 1/62 |
| Cholecystitis acuteHepatobiliary disorders | 0/63 | 1/63 | 0/62 |
| CellulitisInfections and infestations | 1/63 | 0/63 | 0/62 |
| Event | TR-701 200 mg | TR-701 300 mg | TR-701 400 mg |
|---|---|---|---|
| NauseaGastrointestinal disorders | 10/63 | 12/63 | 13/62 |
| HeadacheNervous system disorders | 5/63 | 10/63 | 6/62 |
| AbscessInfections and infestations | 5/63 | 8/63 | 7/62 |
| DiarrheaGastrointestinal disorders | 7/63 | 3/63 | 6/62 |
| VomitingGastrointestinal disorders | 7/63 | 6/63 | 6/62 |
| Skin infectionInfections and infestations | 4/63 | 2/63 | 2/62 |
| Blood pressure increasedInvestigations | 1/63 | 4/63 | 2/62 |
| DizzinessNervous system disorders | 4/63 | 1/63 | 0/62 |
| InsomniaPsychiatric disorders | 1/63 | 4/63 | 1/62 |
| Skin lesionSkin and subcutaneous tissue disorders | 4/63 | 2/63 | 1/62 |
All randomized participants who received study drug.
| Age, Continuous(years) | TR-701 200 mg | TR-701 300 mg | TR-701 400 mg | Total |
|---|---|---|---|---|
| Mean | 37.3 ± 12.1 | 36.0 ± 12.4 | 35.8 ± 12.0 | 36.4 ± 12.1 |
| Sex: Female, Male(Participants) | TR-701 200 mg | TR-701 300 mg | TR-701 400 mg | Total |
|---|---|---|---|---|
| Female | 20 | 24 | 22 | 66 |
| Male | 43 | 39 | 40 | 122 |
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)