Infectious Skin DiseasePhase 2NCT03716024
Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
A Phase 2 study testing PTK 0796 and Linezolid in people with Infectious Skin Disease and Bacterial Skin Disease, run by Paratek Pharmaceuticals Inc at 11 sites in United States.
Trial summary
A Phase II 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 to 80 years
- Conditions the study is for
- Infectious Skin Disease, Bacterial Skin Disease
- 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
- 234 participants
- Where
- 11 sitesUnited States
- Study dates
- 18 Jul 2007to 7 Jan 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, ages 18 years to 80 years
- Has an acute complicated skin and skin structure infection
- 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 past 1 month
- Has been previously enrolled in this protocol
- Has received >48 hr of a potentially effective systemic antibiotic immediately prior to study drug
- Is nursing
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Paratek Recruiting Site
Anaheim, California, 92804
Paratek Recruiting Site
Buena Park, California, 90620
Paratek Recruiting Site
Butte, Montana, 59701
Paratek Recruiting Site
Chula Vista, California, 91911
Paratek Recruiting Site
Electra, Texas, 76360
Paratek Recruiting Site
Hawaiian Gardens, California, 90716
Paratek Recruiting Site
Houston, Texas, 77074
Paratek Recruiting Site
Indianapolis, Indiana, 46280
Paratek Recruiting Site
Oceanside, California, 92056
Paratek Recruiting Site
San Jose, California, 95124
Paratek Recruiting Site
Wichita Falls, Texas, 76301
About this study
Official title: A Randomized, Evaluator-Blinded, Phase 2 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid (Zyvox®) in the Treatment of Adults With Complicated Skin and Skin Structure Infection (cSSSI)
A Phase II 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-0702 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.
- Conditions
- Infectious Skin Disease, Bacterial Skin Disease
- Being tested
- PTK 0796, Linezolid
- Keywords
- CSSSI
- Medical subject headings
- Skin Diseases, Infectious, Skin Diseases, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTK 0796Drug
PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg
LinezolidDrug
Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| PTK 0796 | Experimental | Not described Receives: Drug: PTK 0796 |
| Linezolid | Active comparator | Not described Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population
Clinical response is defined as clinical success (CS), which is categorized as a determination by a blinded evaluator (BE) that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant (par.) received ≥1 dose of test article, the par. did not receive non-study antibiotics on >2 calendar days from Day 1 to the Test of Cure assessment, and the par. did not meet any of the criteria for clinical failure. Clinical failure (CF) is categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the par. received potentially effective antibiotics for treatment of the primary infection site on >2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
Measured: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population
Clinical response is defined as CS, which was categorized as a determination by a BE that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant received ≥1 dose of test article, the participant did not receive non-study antibiotics on >2 calendar days from Day 1 to the Test of Cure assessment, and the participant did not meet any of the criteria for clinical failure. CF was categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the participant received potentially effective antibiotics for treatment of the primary infection site on >2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
Measured: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Secondary outcomes (2)
Number of Participants With Microbiologic Response in the mITT Population
Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study.
Measured: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) Population
Microbiological response to treatment was determined using the following classification: (a) microbiologic success: all infecting pathogens isolated at Baseline were eradicated or presumed eradicated at the Test of Cure evaluation and no superinfecting pathogen was isolated from the site of infection under study; (b) microbiological failure: persistence or presumed persistence of one or more infecting pathogens or isolation of a superinfecting pathogen from the site of infection under study.
Measured: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start18 Jul 2007
- Primary completion7 Jan 2008
- Study completion7 Jan 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 DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paratek Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716024
- Sponsor's protocol ID
- PTK0796-CSSI-0702
- Status last verified
- Sep 2020
- First submitted
- 17 Oct 2018
- Last updated
- 12 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-Blinded, Phase 2 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid (Zyvox®) in the Treatment of Adults With Complicated Skin and Skin Structure Infection (cSSSI)
- ClinicalTrials.gov ID
- NCT03716024
- Acronym / sponsor ID
- PTK0796-CSSI-0702
- Conditions
- Infectious Skin Disease, Bacterial Skin Disease
- Keywords
- CSSSI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Paratek Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2007 (actual)
- Primary completion
- 7 Jan 2008 (actual)
- Study completion
- 7 Jan 2008 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 12 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase II 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-0702 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by 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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTK 0796 | Experimental | Drug: PTK 0796 |
| Linezolid | Active comparator | Drug: Linezolid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients, ages 18 years to 80 years
- Has an acute complicated skin and skin structure infection
- 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 past 1 month
- Has been previously enrolled in this protocol
- Has received >48 hr of a 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 100 mg for injection; PTK 0796 capsule 100 mg | Drug | PTK 0796 |
| LinezolidPre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets | Drug | Linezolid |
Primary outcome
Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population
Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Clinical response is defined as clinical success (CS), which is categorized as a determination by a blinded evaluator (BE) that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant (par.) received ≥1 dose of test article, the par. did not receive non-study antibiotics on >2 calendar days from Day 1 to the Test of Cure assessment, and the par. did not meet any of the criteria for clinical failure. Clinical failure (CF) is categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the par. received potentially effective antibiotics for treatment of the primary infection site on >2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population
Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Clinical response is defined as CS, which was categorized as a determination by a BE that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant received ≥1 dose of test article, the participant did not receive non-study antibiotics on >2 calendar days from Day 1 to the Test of Cure assessment, and the participant did not meet any of the criteria for clinical failure. CF was categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the participant received potentially effective antibiotics for treatment of the primary infection site on >2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
2 secondary outcomes
Number of Participants With Microbiologic Response in the mITT Population
Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) Population
Time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
11 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 PTK 0796 and Linezolid in people with Infectious Skin Disease and Bacterial Skin Disease, run by Paratek Pharmaceuticals Inc at 11 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 3 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: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 Oct 2020). 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 Clinical Response in the Modified Intent-to-Treat (mITT) Population (time frame: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)). 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 12 Oct 2020.