Major Cutaneous AbscessPhase 2NCT01519778

A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study

A Phase 2 study testing TR701 FA in people with Major Cutaneous Abscess and Cellulitis, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Major Cutaneous Abscess, Cellulitis, Erysipelas
What is being tested?: TR701 FA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 10 sitesUnited States
Study dates: 15 Feb 2012to 27 Aug 2012
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients ≥ 18 years of age
Suspected or documented gram-positive infection from baseline Gram stain or culture.
Cellulitis/erysipelas or major cutaneous abscesses at Screening

Who cannot join

Postsurgical or open wound infections
Severe sepsis or septic shock
Uncomplicated skin and skin structure infections such as furuncles, minor abscesses (< 75 cm2 or area of suppuration not surrounded by cellulitis/erythema), and impetiginous lesions
Infections associated with, or in close proximity to, a prosthetic device
Known bacteremia or osteomyelitis at time of screening

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Trius Investigator Site #118
Anaheim, California, 92804
Trius Investigator Site #129
Buena Park, California, 90620
Trius Investigator Site 103
Chula Vista, California, 91911
Trius Investigator Site 101
Columbus, Georgia, 31904
Trius Investigator Site 105
La Mesa, California, 91942
Trius Investigator Site 128
Las Vegas, Nevada, 89109
Trius Investigator Site #106
Long Beach, California, 90813
Trius Investigator Site 104
Oceanside, California, 92056
Trius Investigator Site 102
Savannah, Georgia, 31406
Trius Investigator Site 115
Somers Point, New Jersey, 08244

Other trials in United States

About this study

Official title: Phase 2 Open-Label Safety and Exploratory Skin Lesion Measurement Study of 6-Day Oral TR-701 FA in Skin Abscess and Cellulitis Patients

Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.

Read the detailed description

This is an open-label, multicenter study of oral TR-701 FA 200 mg once daily for 6 days for the treatment of major cutaneous abscess or cellulitis/erysipelas in patients 18 years of age or older. This study is designed to further characterize the safety profile and gather additional lesion measurement data of TR-701 FA in patients with major cutaneous abscess or cellulitis/erysipelas.

Conditions: Major Cutaneous Abscess, Cellulitis, Erysipelas
Being tested: TR701 FA
Medical subject headings: Cellulitis, Erysipelas

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TR701 FADrug
Also called Tedizolid
1 tablet 200 mg once daily

Study groups in NCT01519778
Study group	Role	What they receive
TR-701 FA	Experimental	Not described Receives: Drug: TR701 FA

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).
Measured: 24-31 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201227 Aug 2012

First posted27 Jan 2012 (estimated)
Study start15 Feb 2012
Primary completion27 Aug 2012
Study completion27 Aug 2012

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 Major Cutaneous AbscessStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01519778
Sponsor's protocol ID: 1986-011
Other IDs: TR701-126
Status last verified: Jul 2018
First submitted: 24 Jan 2012
Last updated: 29 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Powers JH 3rd, Das AF, De Anda C, Prokocimer P. Clinician-reported lesion measurements in skin infection trials: Definitions, reliability, and association with patient-reported pain. Contemp Clin Trials. 2016 Sep;50:265-72. doi: 10.1016/j.cct.2016.08.010. Epub 2016 Aug 13.
PubMed 27530088

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Open-Label Safety and Exploratory Skin Lesion Measurement Study of 6-Day Oral TR-701 FA in Skin Abscess and Cellulitis Patients
ClinicalTrials.gov ID: NCT01519778
Acronym / sponsor ID: 1986-011
Conditions: Major Cutaneous Abscess, Cellulitis, Erysipelas
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Collaborators: Bayer
Study start: 15 Feb 2012 (actual)
Primary completion: 27 Aug 2012 (actual)
Study completion: 27 Aug 2012 (actual)
First posted: 27 Jan 2012 (estimated)
Results: Posted 12 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TR-701 FA	Experimental	Drug: TR701 FA

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female patients ≥ 18 years of age
Suspected or documented gram-positive infection from baseline Gram stain or culture.
Cellulitis/erysipelas or major cutaneous abscesses at Screening

Key exclusion criteria (5 listed)

Postsurgical or open wound infections
Severe sepsis or septic shock
Uncomplicated skin and skin structure infections such as furuncles, minor abscesses (< 75 cm2 or area of suppuration not surrounded by cellulitis/erythema), and impetiginous lesions
Infections associated with, or in close proximity to, a prosthetic device
Known bacteremia or osteomyelitis at time of screening

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
TR701 FAAlso: Tedizolid1 tablet 200 mg once daily	Drug	TR-701 FA

Primary outcome

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 24-31 days
Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).

Results and safety

Results posted to the registry on 12 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TR-701 FA	200	186

Primary outcome: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: 24-31 days. Number. Unit: participants

Measure	TR-701 FA n = 200
Value	91

Population analysed: Patients receiving any amount of study drug

Adverse events

Time frame: From the Informed Consent Form signature through the late follow-up visit, up to 32 days.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TR-701 FA	2 of 200 (1%)	58 of 200 (29%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27530088Powers JH 3rd, Das AF, De Anda C, Prokocimer P. Clinician-reported lesion measurements in skin infection trials: Definitions, reliability, and association with patient-reported pain. Contemp Clin Trials. 2016 Sep;50:265-72. doi: 10.1016/j.cct.2016.08.010. Epub 2016 Aug 13.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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 Therapeutics

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 5 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 12 Mar 2015). 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?

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 24-31 days). 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 NCT01519778, 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 29 Aug 2018.