Bacterial InfectionPhase 2NCT00633152
Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
A Phase 2 study testing ceftaroline, linezolid and Aztreonam in people with Bacterial Infection, run by Forest Laboratories at 13 sites in United States.
Trial summary
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infection
- What is being tested?
- ceftaroline, linezolid and Aztreonam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 2008to Jul 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
- Complicated skin and skin structure infection (cSSSI)
- Require initial hospitalization, or treatment in an emergency room or urgent care setting
Who cannot join
- Hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid, aztreonam, or to their components
- Concomitant use of adrenergic or serotonergic agent
- Uncomplicated skin and skin structure infection
- Concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction
- More than 24 hours of treatment with an antimicrobial within 96 hours before randomization
- Known or suspected endocarditis, osteomyelitis, or septic arthritis
- Severely impaired renal function
- Evidence of significant hepatic, hematologic, or immunologic disease
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Investigational Site
Atlantis, Florida, 33462
Investigational Site
Buena Park, California, 96020
Investigational Site
Butte, Montana, 59701
Investigational Site
Columbus, Georgia, 31904
Investigational Site
Columbus, Ohio, 43215
Investigational Site
Long Beach, California, 90813
Investigational Site
Los Angeles, California, 90015
Investigational Site
Minneapolis, Minnesota, 55422
Investigational Site
Rolling Hills Estate, California, 90274
Investigational Site
San Diego, California, 92114
Investigational Site
Savannah, Georgia, 31405
Investigational Site
Somers Point, New Jersey, 08244
Investigational Site
Toledo, Ohio, 43608
About this study
Official title: A Phase 2, Multicenter, Randomized, Open-label, Comparative Study to Evaluate the Efficacy and Safety of Intramuscular Ceftaroline Versus Intravenous Linezolid in Adult Subjects With Complicated Skin and Skin Structure Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.
Read the detailed description
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.
- Conditions
- Bacterial Infection
- Being tested
- ceftaroline, linezolid, Aztreonam
- Keywords
- complicated skin and skin structure infections, linezolid, ceftaroline, clinical response, microbiological response, Cellulitis, Abscess, Wound infection, Deeper soft tissue, Significant surgical intervention, Gram-positive bacterial infection, Gram-negative bacterial infection, bacterial infection, cephalosporin, broad-spectrum activity
- Medical subject headings
- Bacterial Infections, Cellulitis, Abscess, Wound Infection, Gram-Positive Bacterial Infections, Gram-Negative Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftarolineDrug
Also called ceftaroline fosamil, ceftaroline for injection
600 mg injected every 12 hours for at least 5 but not more than 14 days
linezolidDrug
Also called Zyvox, Zyvoxid, CAS number 165800-03-3
600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days
AztreonamDrug
1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.
| Study group | Role | What they receive |
|---|---|---|
| Ceftaroline | Experimental | Intramuscular every 12 hours Receives: Drug: ceftaroline |
| linezolid plus optional aztreonam | Active comparator | Intravenous every 12 hours Receives: Drug: linezolid; Drug: Aztreonam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population
The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.
Measured: Test of Cure Visit (8 to 15 days after end of therapy)
Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population
The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.
Measured: Test of Cure Visit (8 to 15 Days after end of therapy)
Secondary outcomes (7)
Clinical Cure Rate at the TOC Visit in the cMITT Population
Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population.
Measured: TOC Visit (8 to 15 days after end of therapy)
Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations.
Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations.
Measured: End-of-therapy (EOT) visit
The Microbiological Response at the TOC Visit in the mMITT and ME Populations.
Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations.
Measured: TOC Visit (8 to 15 days after end of therapy)
Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations
Evaluate the clinical and microbiological response by pathogen at the TOC Visit in the mMITT and ME populations.
Measured: TOC Visit (8 to 15 days after end of therapy)
Clinical Relapse at the Late Follow-up Visit
Evaluate Clinical relapse rate at Late Follow-up (LFU) (21 to 45 days after the final dose of study drug)in those subjects clinically cured at the TOC visit.
Measured: Late Follow-up (LFU) Visit (21 to 35 days after end of therapy)
The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit
Evaluate per-subject reinfection or recurrence rate at the LFU Visit in those subjects who had a favorable microbiological outcome (eradication or presumed eradication) at the TOC Visit.
Measured: LFU Visit (21 to 35 days after end of therapy)
The Safety of Ceftaroline Fosamil
Evaluate safety of Ceftaroline fosamil IM in adults with complicated skin and skin structure infection (cSSSI)
Measured: First dose of study drug through LFU Visit or 30 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 posted11 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2008
- Study completionJul 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 Bacterial InfectionStudies 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
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor Cerexa, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633152
- Sponsor's protocol ID
- P903-19
- Status last verified
- Feb 2017
- First submitted
- 3 Mar 2008
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. 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 Efficacy and Safety of Intramuscular Ceftaroline Versus Intravenous Linezolid in Adult Subjects With Complicated Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT00633152
- Acronym / sponsor ID
- P903-19
- Conditions
- Bacterial Infection
- Keywords
- complicated skin and skin structure infections, linezolid, ceftaroline, clinical response, microbiological response, Cellulitis, Abscess, Wound infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Posted 31 Aug 2012
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 whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.
Detailed description
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftaroline | Experimental | Drug: ceftarolineIntramuscular every 12 hours |
| linezolid plus optional aztreonam | Active comparator | Drug: linezolid, Drug: AztreonamIntravenous every 12 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complicated skin and skin structure infection (cSSSI)
- Require initial hospitalization, or treatment in an emergency room or urgent care setting
Key exclusion criteria (8 listed)
- Hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid, aztreonam, or to their components
- Concomitant use of adrenergic or serotonergic agent
- Uncomplicated skin and skin structure infection
- Concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction
- More than 24 hours of treatment with an antimicrobial within 96 hours before randomization
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 |
|---|---|---|
| ceftarolineAlso: ceftaroline fosamil, ceftaroline for injection600 mg injected every 12 hours for at least 5 but not more than 14 days | Drug | Ceftaroline |
| linezolidAlso: Zyvox, Zyvoxid, CAS number 165800-03-3600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days | Drug | linezolid plus optional aztreonam |
| Aztreonam1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated. | Drug | linezolid plus optional aztreonam |
Primary outcome
Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population
Time frame: Test of Cure Visit (8 to 15 days after end of therapy)
The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.
Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population
Time frame: Test of Cure Visit (8 to 15 Days after end of therapy)
The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.
7 secondary outcomes
Clinical Cure Rate at the TOC Visit in the cMITT Population
Time frame: TOC Visit (8 to 15 days after end of therapy)
Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations.
Time frame: End-of-therapy (EOT) visit
The Microbiological Response at the TOC Visit in the mMITT and ME Populations.
Time frame: TOC Visit (8 to 15 days after end of therapy)
Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations
Time frame: TOC Visit (8 to 15 days after end of therapy)
Clinical Relapse at the Late Follow-up Visit
Time frame: Late Follow-up (LFU) Visit (21 to 35 days after end of therapy)
The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit
Time frame: LFU Visit (21 to 35 days after end of therapy)
The Safety of Ceftaroline Fosamil
Time frame: First dose of study drug through LFU Visit or 30 days after the last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bacterial Infection
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
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.
Medical Monitor Cerexa study director
Forest Laboratories
13 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 ceftaroline, linezolid and Aztreonam in people with Bacterial Infection, run by Forest Laboratories at 13 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 8 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 31 Aug 2012). 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 at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population (time frame: Test of Cure Visit (8 to 15 days after end of therapy)). 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?
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 14 Mar 2017.