NCT03716024

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2008

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 12, 2020

Completed
Last Updated

October 12, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

October 17, 2018

Results QC Date

September 17, 2020

Last Update Submit

September 17, 2020

Conditions

Infectious Skin DiseaseBacterial Skin Disease

Keywords

CSSSI

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)

Study Arms (2)

PTK 0796

EXPERIMENTAL
Drug: PTK 0796

Linezolid

ACTIVE COMPARATOR
Drug: Linezolid

Interventions

PTK 0796DRUG

PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg

PTK 0796
LinezolidDRUG

Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets

Linezolid

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Paratek Recruiting Site

Anaheim, California, 92804, United States

Location

Paratek Recruiting Site

Buena Park, California, 90620, United States

Location

Paratek Recruiting Site

Chula Vista, California, 91911, United States

Location

Paratek Recruiting Site

Hawaiian Gardens, California, 90716, United States

Location

Paratek Recruiting Site

Oceanside, California, 92056, United States

Location

Paratek Recruiting Site

San Jose, California, 95124, United States

Location

Paratek Recruiting Site

Indianapolis, Indiana, 46280, United States

Location

Paratek Recruiting Site

Butte, Montana, 59701, United States

Location

Paratek Recruiting Site

Electra, Texas, 76360, United States

Location

Paratek Recruiting Site

Houston, Texas, 77074, United States

Location

Paratek Recruiting Site

Wichita Falls, Texas, 76301, United States

Location

MeSH Terms

Conditions

Skin Diseases, InfectiousSkin Diseases, Bacterial

Interventions

7-dimethylamino-9-(2,2-dimethylpropyl)aminomethylcyclineLinezolid

Condition Hierarchy (Ancestors)

InfectionsSkin DiseasesSkin and Connective Tissue DiseasesBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Paratek Medical Information
Organization
Paratek Pharmaceuticals, Inc.
medinfo@paratekpharma.com
1-833-727-2835

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 23, 2018

Study Start

July 18, 2007

Primary Completion

January 7, 2008

Study Completion

January 7, 2008

Last Updated

October 12, 2020

Results First Posted

October 12, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(11)