Skin Diseases, InfectiousPhase 2NCT00761215
Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
A Phase 2 study testing TR-701 200 mg, TR-701 300 mg and TR-701 400 mg in people with Skin Diseases, Infectious and Skin Diseases, Bacterial, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Skin Diseases, Infectious, Skin Diseases, Bacterial
- What is being tested?
- TR-701 200 mg, TR-701 300 mg and TR-701 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 12 sitesUnited States
- Study dates
- 17 Sep 2008to 24 Feb 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms
- Suspected or confirmed infection due to a gram-positive organism
Who cannot join
- Complicated skin and skin structure infection due to gram-negative organisms
- Complicated skin and skin structure infections requiring more than 7 days of therapy
- Uncontrolled diabetes
- Chronic systemic immunosuppressive therapy
- AIDS with CD4 count < 200 cells/mm3
- Uncontrolled hypertension
Show all 11Show fewer
- Mild moderate or severe renal failure
- Severe hepatic disease
- Neutropenia
- Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug
- Women who are pregnant or nursing
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Trius Study site #001
Chula Vista, California, 91911
Trius Study site 004
Columbus, Georgia, 31904
Trius study sie #008
Detroit, Michigan, 48202
Trius Study Site #011
Dothan, Alabama, 36301
Trius Study Site #009
Long Beach, California, 92708
Trius Study site #006
Ludowici, Georgia, 31316
Trius Study site #002
Oceanside, California, 92056
Trius Study site #010
Pasadena, California, 91105
Trius Study site 007
San Francisco, California, 94143
Trius Study site 003
San Jose, California, 95124
Trius Study site #005
Savannah, Georgia, 31406
Trius Study site #012
Springfield, Illinois, 62701
About this study
Official title: A Phase 2 Multi-Center, Randomized, Double-Blind, Non-Controlled Study Comparing the Safety, Tolerance, and Efficacy of TR-701 in Patients With Complicated Skin and Skin Structure Infections
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.
- Being tested
- TR-701 200 mg, TR-701 300 mg, TR-701 400 mg
- Keywords
- Skin, Infection, Complicated Skin and Skin Structure Infection
- Medical subject headings
- Skin Diseases, Infectious, Skin Diseases, Bacterial, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR-701 200 mgDrug
oral TR-701 200 mg for 5 to 7 days
TR-701 300 mgDrug
oral TR-701 300 mg for 5 to 7 days
TR-701 400 mgDrug
TR-701 400 mg for 5 to 7 days
| Study group | Role | What they receive |
|---|---|---|
| TR-701 200 mg | Experimental | Not described Receives: Drug: TR-701 200 mg |
| TR-701 300 mg | Experimental | Not described Receives: Drug: TR-701 300 mg |
| TR-701 400 mg | Experimental | Not described Receives: Drug: TR-701 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7-14 days after last dose of study drug
Secondary outcomes (6)
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.
Measured: 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
Measured: 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.
Measured: 21 to 28 days after the last study drug
To Evaluate the Safety Profile of Tedizolid Phosphate
Measured: Multiple
Population PK
Measured: Multiple
Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set
Measured: 21-28 days after last study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study start17 Sep 2008
- Primary completion24 Feb 2009
- Study completion24 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin Diseases, InfectiousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Prokocimer, MD, Study chair, Trius
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761215
- Sponsor's protocol ID
- 1986-007
- Other IDs
- TR701-104
- Status last verified
- Nov 2019
- First submitted
- 25 Sep 2008
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Prokocimer P, Bien P, Deanda C, Pillar CM, Bartizal K. In vitro activity and microbiological efficacy of tedizolid (TR-700) against Gram-positive clinical isolates from a phase 2 study of oral tedizolid phosphate (TR-701) in patients with complicated skin and skin structure infections. Antimicrob Agents Chemother. 2012 Sep;56(9):4608-13. doi: 10.1128/AAC.00458-12. Epub 2012 Jun 11.
PubMed 22687509
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-Center, Randomized, Double-Blind, Non-Controlled Study Comparing the Safety, Tolerance, and Efficacy of TR-701 in Patients With Complicated Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT00761215
- Acronym / sponsor ID
- 1986-007
- Keywords
- Skin, Infection, Complicated Skin and Skin Structure Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2008 (actual)
- Primary completion
- 24 Feb 2009 (actual)
- Study completion
- 24 Feb 2009 (actual)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Posted 7 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TR-701 200 mg | Experimental | Drug: TR-701 200 mg |
| TR-701 300 mg | Experimental | Drug: TR-701 300 mg |
| TR-701 400 mg | Experimental | Drug: TR-701 400 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms
- Suspected or confirmed infection due to a gram-positive organism
Key exclusion criteria (11 listed)
- Complicated skin and skin structure infection due to gram-negative organisms
- Complicated skin and skin structure infections requiring more than 7 days of therapy
- Uncontrolled diabetes
- Chronic systemic immunosuppressive therapy
- AIDS with CD4 count < 200 cells/mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TR-701 200 mgoral TR-701 200 mg for 5 to 7 days | Drug | TR-701 200 mg |
| TR-701 300 mgoral TR-701 300 mg for 5 to 7 days | Drug | TR-701 300 mg |
| TR-701 400 mgTR-701 400 mg for 5 to 7 days | Drug | TR-701 400 mg |
Primary outcome
Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set
Time frame: 7 to 14 days after the last dose of study drug
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.
Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set
Time frame: 7-14 days after last dose of study drug
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.
6 secondary outcomes
Response Rate at End of Therapy
Time frame: last day of study treatment
Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22687509Prokocimer P, Bien P, Deanda C, Pillar CM, Bartizal K. In vitro activity and microbiological efficacy of tedizolid (TR-700) against Gram-positive clinical isolates from a phase 2 study of oral tedizolid phosphate (TR-701) in patients with complicated skin and skin structure infections. Antimicrob Agents Chemother. 2012 Sep;56(9):4608-13. doi: 10.1128/AAC.00458-12. Epub 2012 Jun 11.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Prokocimer, MD study chair
Trius
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TR-701 200 mg, TR-701 300 mg and TR-701 400 mg in people with Skin Diseases, Infectious and Skin Diseases, Bacterial, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set (time frame: 7 to 14 days after the last dose of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00761215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.