Skin Diseases, BacterialPhase 2NCT00948142
Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
A Phase 2 study testing CEM-102 and Linezolid in people with Skin Diseases, Bacterial, run by Arrevus Inc. at 16 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Diseases, Bacterial
- What is being tested?
- CEM-102 and Linezolid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 16 sitesUnited States
- Study dates
- Aug 2009to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days duration which was suspected or proven to be caused, at least in part, by a gram-positive pathogen.
- Eligible infections included cellulitis measuring at least 10 cm length and width or 100 cm squared, with or without a focal abscess, and surgical or traumatic wound infections
- Infection which in the opinion of the investigator will require 10-14 days of antibacterial therapy.
- Have at least 3 of the following local and/or systemic symptoms and/or signs of infection: purulent or seropurulent drainage/discharge, erythema, fluctuance, heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional lymph node swelling or tenderness, temperature >=100.4 degree F, increased white blood cell count, or bandemia.
- Must not have received treatment with another systemic antibiotic for the current ABSSI.
Who cannot join
- Superficial skin structure infections such as folliculitis, carbuncles, furunculosis, cutaneous abscesses, and simple cellulitis.
- Infections involving burns, human or animal bites, or chronic diabetic foot ulcers.
- Suspected polymicrobial infection involving Pseudomonas aeruginosa
- Anticipated need for >14 days of antibiotic therapy.
- Infections complicated by the presence of prosthetic materials that will not be removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement prosthesis.
- Known significant renal, hepatic, or hematologic impairment.
- Received prior potentially effective antimicrobial therapy for the acute bacterial skin and skin structure infection, unless they were failing therapy after 48 hours or had a gram-positive pathogen non-susceptible to prior therapy identified as a causative pathogen.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Study site
Akron, Ohio, 44304
Study site
Butte, Montana, 59701
Study site
Chula Vista, California, 91911
Study site
Columbus, Georgia, 31904
Study site
Detroit, Michigan, 48202
Study site
La Mesa, California, 91942
Study site
Los Angeles, California, 90015
Study site
Oceanside, California, 92056
Study site
Oxnard, California, 93030
Study site
Pasadena, California, 91105
Study site
Santa Ana, California, 92701
Study site
Savannah, Georgia, 31406
Study site
Somers Point, New Jersey, 08244
Study site
Springfield, Illinois, 62701
Study site
Torrance, California, 90501
Study site
Torrance, California, 90509
About this study
Official title: A Phase 2, Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of CEM-102 Compared to Linezolid in the Treatment of Acute Bacterial Skin Structure Infections
The purpose of this study is to determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).
Read the detailed description
ABSSIs are common and affect all age groups. In recent years, ABSSIs caused by multi-drug resistant pathogens, especially methicillin-resistant Staphylococcus aureus (MRSA) have become more common. There is an urgent need for additional antibacterial drugs with modes of action different from those currently available. CEM-102 is one such agent with excellent activity against S. aureus, including MRSA.
- Conditions
- Skin Diseases, Bacterial
- Being tested
- CEM-102, Linezolid
- Keywords
- Acute Bacterial Skin and Skin Struction Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections; MRSA
- Medical subject headings
- Skin Diseases, Bacterial, Staphylococcal Skin Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEM-102Drug
Also called fusidic acid
600 mg BID oral tablets for 10-14 days
LinezolidDrug
Also called Zyvox
600 mg BID oral tablets
CEM-102Drug
Also called fusidic acid
1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days
| Study group | Role | What they receive |
|---|---|---|
| Linezolid | Active comparator | 600 mg BID Receives: Drug: Linezolid |
| CEM-102 Regimen A | Experimental | Not described Receives: Drug: CEM-102 |
| CEM-102 Regimen B | Experimental | Not described Receives: Drug: CEM-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population
Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required
Measured: 7 to 14 days after the last dose of study drug
Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population
Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required
Measured: 7 to 14 days after the last dose of study drug
Secondary outcomes (12)
Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population
Meets the following definition for clinical success: Complete resolution of the signs and symptoms of the ABSSI and no further study drug therapy is required.
Measured: 10-14 days of study drug
Clinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population
Meets the following definition for clinical success: Complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.
Measured: 7 to 14 days after the last dose of study drug
Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population
Meets the following definition for clinical success: complete resolution of the signs and symptoms of the ABSSI and no further study drug therapy is required.
Measured: 10-14 days of study drug
Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population
Meets the following definition for clinical success at the end of treatment: complete resolutoin of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required
Measured: 10-14 days of study drug
Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population
Meets the following definition for clinical success: complete resolution of signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.
Measured: 10-14 days of study drug
Clinical Success at test of cure (TOC) for the microbiologically evaluable (ME) population
Meets the following definition of clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.
Measured: 7-14 days after the last dose of study drug
Clinical success at the test of cure (TOC) by baseline pathogen for the microbiological intent-to-treat (MITT) population
Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additonal systemic antibacterial therapy is required
Measured: 7-14 days after the last dose of study drug
Clinical success at test of cure (TOC) by baseline pathogen for the microbiologically evaluable (ME) population
Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required
Measured: 7 to 14 days after the last dose of study drug
By-pathogen microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population
Successful responses included:
eradication: the basline causative pathogen was absent from the culture(s) presumed eradication: the patient's clincial response was success, and no culture available.
Measured: 7-14 days after the last dose of study drug
By-pathogen microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population
Successful responses included:
eradication: the basline causative pathogen was absent from the culture(s) presumed eradication: the patient's clincial response was success, and no culture available.
Measured: 7-14 days after the last dose of study drug
By-patient microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population
Successful responses included:
eradication: the baseline causative organisms have a response of eradication. presumed eradication: all baseline causative organism(s) have a response of presumed eradication combined eradication/presumed eradication: in cases where baseline causative organisms were from a blood and an ABSSI culture
Measured: 7-14 days after the last dose of study drug
By-patient microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population
Successful responses included:
eradication: the baseline causative organisms have a response of eradication. presumed eradication: all baseline causative organism(s) have a response of presumed eradication combined eradication/presumed eradication: in cases where baseline causative organisms were from a blood and an ABSSI culture
Measured: 7-14 days after the last dose of 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 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin Diseases, BacterialStudies 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
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrevus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948142
- Sponsor's protocol ID
- CE06-300
- Status last verified
- Apr 2019
- First submitted
- 28 Jul 2009
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Craft JC, Moriarty SR, Clark K, Scott D, Degenhardt TP, Still JG, Corey GR, Das A, Fernandes P. A randomized, double-blind phase 2 study comparing the efficacy and safety of an oral fusidic acid loading-dose regimen to oral linezolid for the treatment of acute bacterial skin and skin structure infections. Clin Infect Dis. 2011 Jun;52 Suppl 7:S520-6. doi: 10.1093/cid/cir167.
PubMed 21546629
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of CEM-102 Compared to Linezolid in the Treatment of Acute Bacterial Skin Structure Infections
- ClinicalTrials.gov ID
- NCT00948142
- Acronym / sponsor ID
- CE06-300
- Conditions
- Skin Diseases, Bacterial
- Keywords
- Acute Bacterial Skin and Skin Struction Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections; MRSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Arrevus Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Not posted in the source record
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 determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).
Detailed description
ABSSIs are common and affect all age groups. In recent years, ABSSIs caused by multi-drug resistant pathogens, especially methicillin-resistant Staphylococcus aureus (MRSA) have become more common. There is an urgent need for additional antibacterial drugs with modes of action different from those currently available. CEM-102 is one such agent with excellent activity against S. aureus, including MRSA.
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 |
|---|---|---|
| Linezolid | Active comparator | Drug: Linezolid600 mg BID |
| CEM-102 Regimen A | Experimental | Drug: CEM-102 |
| CEM-102 Regimen B | Experimental | Drug: CEM-102 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days duration which was suspected or proven to be caused, at least in part, by a gram-positive pathogen.
- Eligible infections included cellulitis measuring at least 10 cm length and width or 100 cm squared, with or without a focal abscess, and surgical or traumatic wound infections
- Infection which in the opinion of the investigator will require 10-14 days of antibacterial therapy.
- Have at least 3 of the following local and/or systemic symptoms and/or signs of infection: purulent or seropurulent drainage/discharge, erythema, fluctuance, heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional lymph node swelling or tenderness, temperature >=100.4 degree F, increased white blood cell count, or bandemia.
- Must not have received treatment with another systemic antibiotic for the current ABSSI.
Key exclusion criteria (7 listed)
- Superficial skin structure infections such as folliculitis, carbuncles, furunculosis, cutaneous abscesses, and simple cellulitis.
- Infections involving burns, human or animal bites, or chronic diabetic foot ulcers.
- Suspected polymicrobial infection involving Pseudomonas aeruginosa
- Anticipated need for >14 days of antibiotic therapy.
- Infections complicated by the presence of prosthetic materials that will not be removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement prosthesis.
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 |
|---|---|---|
| CEM-102Also: fusidic acid600 mg BID oral tablets for 10-14 days | Drug | CEM-102 Regimen A |
| LinezolidAlso: Zyvox600 mg BID oral tablets | Drug | Linezolid |
| CEM-102Also: fusidic acid1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days | Drug | CEM-102 Regimen B |
Primary outcome
Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population
Time frame: 7 to 14 days after the last dose of study drug
Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required
Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population
Time frame: 7 to 14 days after the last dose of study drug
Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required
12 secondary outcomes
Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population
Time frame: 10-14 days of study drug
Clinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population
Time frame: 7 to 14 days after the last dose of study drug
Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population
Time frame: 10-14 days of study drug
Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population
Time frame: 10-14 days of study drug
Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population
Time frame: 10-14 days of study drug
Clinical Success at test of cure (TOC) for the microbiologically evaluable (ME) population
Time frame: 7-14 days after the last dose of study drug
Clinical success at the test of cure (TOC) by baseline pathogen for the microbiological intent-to-treat (MITT) population
Time frame: 7-14 days after the last dose of study drug
Clinical success at test of cure (TOC) by baseline pathogen for the microbiologically evaluable (ME) population
Time frame: 7 to 14 days after the last dose of study drug
By-pathogen microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population
Time frame: 7-14 days after the last dose of study drug
By-pathogen microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population
Time frame: 7-14 days after the last dose of study drug
By-patient microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population
Time frame: 7-14 days after the last dose of study drug
By-patient microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population
Time frame: 7-14 days after the last dose of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Derived from this study: PubMed 21546629Craft JC, Moriarty SR, Clark K, Scott D, Degenhardt TP, Still JG, Corey GR, Das A, Fernandes P. A randomized, double-blind phase 2 study comparing the efficacy and safety of an oral fusidic acid loading-dose regimen to oral linezolid for the treatment of acute bacterial skin and skin structure infections. Clin Infect Dis. 2011 Jun;52 Suppl 7:S520-6. doi: 10.1093/cid/cir167.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 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 CEM-102 and Linezolid in people with Skin Diseases, Bacterial, run by Arrevus Inc. at 16 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 5 inclusion and 7 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 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Success at Test of Cure (TOC) for the intent-to-treat (ITT) population (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 NCT00948142, 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 19 Apr 2019.