Skin Structures and Soft Tissue InfectionsPhase 3NCT00876850
Phase 3 Study - Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
A Phase 3 study testing PTK 0796 and Linezolid in people with Skin Structures and Soft Tissue Infections, run by Paratek Pharmaceuticals Inc.
Trial summary
A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Structures and Soft Tissue Infections
- What is being tested?
- PTK 0796 and Linezolid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Aug 2010
- Phase
- Phase 3
- 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
- Has and acute complicated skin and skin structure infection with findings of systemic inflammatory response
- Patients, ages 18 years or older
- Is expected to require greater than or equal to 4 days antibiotic therapy
- Female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
Who cannot join
- Has received an investigational drug within the past 1 month
- Has been previously enrolled in this protocol
- Has received >48hr of potentially effective systemic antibiotic immediately prior to study drug
- Is nursing
About this study
Official title: A Randomized, Evaluator-Blinded, Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid in the Treatment of Adults With Complicated Skin and Skin Structure Infection
A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).
Read the detailed description
The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.
In PTK 0796-CSSI-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by the FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.
- Being tested
- PTK 0796, Linezolid
- Keywords
- cSSI, Abscess, Would, Cellulitis, Complicated Skin and Skin Structure Infections (cSSSI)
- Medical subject headings
- Soft Tissue Infections, Abscess, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTK 0796Drug
PTK 0796 100mg for injection; PTK 0796 tablet 150mg
LinezolidDrug
Also called Zyvox™; Avelox™
For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400mg tablets and pre-mixed 400mg IV infusion solution
| Study group | Role | What they receive |
|---|---|---|
| PTK 0796 | Experimental | PTK 0796 100mg for injection; PTK 0796 tablet 150mg Receives: Drug: PTK 0796 |
| Linezolid | Active comparator | For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success at follow-up
Measured: 4 weeks after enrollment
Secondary outcomes (1)
To evaluate safety of dosing regimens
Measured: 4 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010 (estimated)
- Study completionAug 2010 (estimated)
Why it stopped: Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Structures and Soft Tissue InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paratek Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Arbeit, MD, Study director, Paratek Pharmaceuticals Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876850
- Sponsor's protocol ID
- PTK 0796-CSSI-0805
- Status last verified
- May 2012
- First submitted
- 6 Apr 2009
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-Blinded, Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid in the Treatment of Adults With Complicated Skin and Skin Structure Infection
- ClinicalTrials.gov ID
- NCT00876850
- Acronym / sponsor ID
- PTK 0796-CSSI-0805
- Keywords
- cSSI, Abscess, Would, Cellulitis, Complicated Skin and Skin Structure Infections (cSSSI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Paratek Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 7 Apr 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.
A Phase III trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).
Detailed description
The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.
In PTK 0796-CSSI-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by the FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTK 0796 | Experimental | Drug: PTK 0796PTK 0796 100mg for injection; PTK 0796 tablet 150mg |
| Linezolid | Active comparator | Drug: LinezolidFor gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has and acute complicated skin and skin structure infection with findings of systemic inflammatory response
- Patients, ages 18 years or older
- Is expected to require greater than or equal to 4 days antibiotic therapy
- Female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
Key exclusion criteria (4 listed)
- Has received an investigational drug within the past 1 month
- Has been previously enrolled in this protocol
- Has received >48hr of potentially effective systemic antibiotic immediately prior to study drug
- Is nursing
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 |
|---|---|---|
| PTK 0796PTK 0796 100mg for injection; PTK 0796 tablet 150mg | Drug | PTK 0796 |
| LinezolidAlso: Zyvox™; Avelox™For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400mg tablets and pre-mixed 400mg IV infusion solution | Drug | Linezolid |
Primary outcome
Clinical success at follow-up
Time frame: 4 weeks after enrollment
1 secondary outcome
To evaluate safety of dosing regimens
Time frame: 4 weeks after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.
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.
Robert Arbeit, MD study director
Paratek Pharmaceuticals Inc
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PTK 0796 and Linezolid in people with Skin Structures and Soft Tissue Infections, run by Paratek Pharmaceuticals Inc.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 9 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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 follow-up (time frame: 4 weeks after enrollment). 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 9 May 2012.