Infectious Skin DiseasesPhase 2NCT00646958
Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections
A Phase 2 study testing Radezolid and Linezolid in people with Infectious Skin Diseases and Bacterial Skin Diseases, run by Melinta Therapeutics, Inc. at 19 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Skin Diseases, Bacterial Skin Diseases, Staphylococcal Skin Infections
- What is being tested?
- Radezolid and Linezolid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 19 sitesUnited States
- Study dates
- Dec 2007to Apr 2008
- 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
- Adult patients with uSSSI
- Adult (men and women) ≥18 years
- Females must be post-menopausal for at least 1 year or surgically sterile
- Sexually active males must use a barrier method of birth control during and for 30 days after the study
- Acceptable clinical diagnoses of uSSSI include, but are not limited to: Simple abscess, Impetiginous lesions, Folliculitis, Furunculosis, Carbuncles, Cellulitis
- The infection is accompanied by 2 or more of the following local signs and symptoms: Pain/tenderness, Swelling, Erythema, Localized warmth, Purulent drainage/discharge, Induration, Regional lymph node swelling or tenderness, Extension of redness
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- A sample for microbiologic culture must be obtained from the primary infection site at the screening visit
- The patient must require and be a suitable candidate for oral antibiotic therapy in the opinion of the Investigator and be able to swallow tablets or capsules intact
- A written, voluntarily signed informed consent must be obtained from the patient prior to the initiation of any study-related procedures
Who cannot join
- Cellulitis (area greater than 10cm2), chronic or recurrent furunculosis, postoperative wound infection, leg ulcer, decubitus ulcer(s), erysipelas, progressive lymphangitis, acute paronychia or a deep tissue abscess such as pilonidal or breast abscess. Also excluded are skin infections resulting from animal bites
- Patients with a complicated skin and skin structure infection as judged by the Investigator
- Infections that can be treated by surgical incision alone according to the judgment of the Investigator
- Treatment with the following anti-infective agents prior to study drug administration: systemic antibiotic within 7 days; azithromycin within 14 days; a long-acting injectable antibiotic within 30 days
- Any infection which requires the use of a concomitant antimicrobial agent, in addition to study drug
- Concomitant topical therapy at the infection site for the period within 48 hours prior to study drug administration through TOC
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- A chronic or underlying skin condition at the site of infection or infections involving prosthetic materials
- A wound secondary to burn injury or acne vulgaris
- Any infection site that requires: intraoperative surgical debridement; excision of infected area
- Documented or suspected bacteremia
- Fungal infection involving the nail bed or scalp at the primary uSSSI site
- Significant peripheral vascular disease
- An abscess at an anatomical location where the incidence of anaerobic pathogen involvement is increased
- Patient receiving a daily dose of > 15 mg of systemic prednisone or equivalent, for > 10 days within the period starting 14 days prior to study drug administration or anticipated through TOC
- Patient with known human immunodeficiency virus (HIV) infection.
- Medical history of hypersensitivity or allergic reaction to linezolid according to the judgment of the Investigator
- Patients receiving serotonergic agents, selective serotonin reuptake inhibitors (SSRIs), or monoamine oxidase inhibitors (MAOIs)
- Patients who have severe liver disease
- History of pheochromocytoma, untreated hyperthyroidism, untreated or uncontrolled hypertension, carcinoid syndrome
- Evidence of uncontrolled, clinically significant (according to the judgment of the Investigator) cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or endocrine disease; malignancy or psychiatric disorder
- Current evidence of deep vein thrombosis or superficial thrombophlebitis
- Experienced a recent clinically significant coagulopathy
- Evidence of clinically significant immunosuppression
- Patient who previously enrolled in this study
- Patient who has previously enrolled in any other clinical trial within 4 weeks of enrollment through TOC. Treatment with an investigational drug within 4 weeks prior to study drug administration
- Patient residing in a chronic care facility
- Any underlying condition or disease state that would interfere with the completion of the study procedures and evaluation of the absorption of study drug
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Summa Health System
Akron, Ohio
South Florida Clinical Research
Atlantis, Florida
Mercury Street Medical Group, LLC
Butte, Montana
Southeast Regional Research Group
Columbus, Georgia
Brandywine Clinical Research
Downington, Pennsylvania
Contemporary Medicine, LLC
Hinesville, Georgia
Infectious Disease of Indiana, PSC.
Indianapolis, Indiana
Jamaica Hospital Medical Center
Jamaica, New York
Arnold Markowitz, MD., PC
Keego Harbor, Michigan
OWENS Pharma Research Center
Long Beach, California
Healthcare Partners Medical Group
Los Angeles, California
McKenzie Medical Center
McKenzie, Tennessee
Drug Research & Analysis Corp
Montgomery, Alabama
HealthCare Partners Medical Group
Pasadena, California
J. Lewis Research, Inc.
Salt Lake City, Utah
Clinical Trials of America, Inc.
Shreveport, Louisiana
Olive View- UCLA Center, Dept. Emergency Medicine
Sylmar, California
Warminster Medical Associates, P.C.
Warminster, Pennsylvania
ALL-TRIALS Clinical Research, LLC
Winston-Salem, North Carolina
About this study
Official title: A Phase 2, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety and Efficacy of RX-1741 Versus Linezolid in the Outpatient Treatment of Adult Patients With Uncomplicated Skin and Skin Structure Infection
The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections
- Conditions
- Infectious Skin Diseases, Bacterial Skin Diseases, Staphylococcal Skin Infections, Streptococcal Infections, Abscess
- Being tested
- Radezolid, Linezolid
- Medical subject headings
- Skin Diseases, Infectious, Skin Diseases, Bacterial, Staphylococcal Skin Infections, Streptococcal Infections, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadezolidDrug
Also called RX-1741
450mg PO QD
RadezolidDrug
Also called RX-1741
450mg PO BID
LinezolidDrug
Also called Zyvox
600mg PO BID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Radezolid 450 mg PO QD Receives: Drug: Radezolid |
| 2 | Experimental | Radezolid 450 mg PO BID Receives: Drug: Radezolid |
| 3 | Active comparator | Linezolid 600 mg PO BID Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Clinical Response of Cure
To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.
Measured: Test of Cure (TOC), day 10-20
Secondary outcomes (1)
Number of Patients With Per-Patient Microbiologic Response of Eradicated
The microbiological response at the patient level was considered Eradicated (documented or presumed)if no pathogens were present in repeat cultures taken from the original site of infection or a clinical response of cure precluded the ability to obtain a culturable specimen.
Measured: Test of Cure (TOC), day 10-20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2008
- Study completionApr 2008
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.
- Other trials for Infectious Skin DiseasesStudies 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
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Hopkins, MD, Study director, Melinta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646958
- Sponsor's protocol ID
- RX-1741-202
- Status last verified
- Feb 2014
- First submitted
- 26 Mar 2008
- Last updated
- 27 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety and Efficacy of RX-1741 Versus Linezolid in the Outpatient Treatment of Adult Patients With Uncomplicated Skin and Skin Structure Infection
- ClinicalTrials.gov ID
- NCT00646958
- Acronym / sponsor ID
- RX-1741-202
- Conditions
- Infectious Skin Diseases, Bacterial Skin Diseases, Staphylococcal Skin Infections, Streptococcal Infections, Abscess
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Mar 2008 (estimated)
- Results
- Posted 26 Jun 2009
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 this study is to assess the efficacy, safety and tolerability of RX-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RadezolidRadezolid 450 mg PO QD |
| 2 | Experimental | Drug: RadezolidRadezolid 450 mg PO BID |
| 3 | Active comparator | Drug: LinezolidLinezolid 600 mg PO BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients with uSSSI
- Adult (men and women) ≥18 years
- Females must be post-menopausal for at least 1 year or surgically sterile
- Sexually active males must use a barrier method of birth control during and for 30 days after the study
- Acceptable clinical diagnoses of uSSSI include, but are not limited to: Simple abscess, Impetiginous lesions, Folliculitis, Furunculosis, Carbuncles, Cellulitis
Key exclusion criteria (27 listed)
- Cellulitis (area greater than 10cm2), chronic or recurrent furunculosis, postoperative wound infection, leg ulcer, decubitus ulcer(s), erysipelas, progressive lymphangitis, acute paronychia or a deep tissue abscess such as pilonidal or breast abscess. Also excluded are skin infections resulting from animal bites
- Patients with a complicated skin and skin structure infection as judged by the Investigator
- Infections that can be treated by surgical incision alone according to the judgment of the Investigator
- Treatment with the following anti-infective agents prior to study drug administration: systemic antibiotic within 7 days; azithromycin within 14 days; a long-acting injectable antibiotic within 30 days
- Any infection which requires the use of a concomitant antimicrobial agent, in addition to study drug
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 |
|---|---|---|
| RadezolidAlso: RX-1741450mg PO QD | Drug | 1 |
| RadezolidAlso: RX-1741450mg PO BID | Drug | 2 |
| LinezolidAlso: Zyvox600mg PO BID | Drug | 3 |
Primary outcome
Number of Participants With a Clinical Response of Cure
Time frame: Test of Cure (TOC), day 10-20
To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.
1 secondary outcome
Number of Patients With Per-Patient Microbiologic Response of Eradicated
Time frame: Test of Cure (TOC), day 10-20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Scott Hopkins, MD study director
Melinta Therapeutics, Inc.
19 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 Radezolid and Linezolid in people with Infectious Skin Diseases and Bacterial Skin Diseases, run by Melinta Therapeutics, Inc. at 19 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 9 inclusion and 27 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 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 26 Jun 2009). 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?
Number of Participants With a Clinical Response of Cure (time frame: Test of Cure (TOC), day 10-20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2014.