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A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTK 0796 | Experimental |
| |
| Linezolid | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTK 0796 | Drug | PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paratek Recruiting Site | Anaheim | California | 92804 | United States | ||
| Paratek Recruiting Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omadacycline | Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Linezolid |
| Drug |
Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets |
|
| 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. | 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days) |
| Buena Park |
| California |
| 90620 |
| United States |
| Paratek Recruiting Site | Chula Vista | California | 91911 | United States |
| Paratek Recruiting Site | Hawaiian Gardens | California | 90716 | United States |
| Paratek Recruiting Site | Oceanside | California | 92056 | United States |
| Paratek Recruiting Site | San Jose | California | 95124 | United States |
| Paratek Recruiting Site | Indianapolis | Indiana | 46280 | United States |
| Paratek Recruiting Site | Butte | Montana | 59701 | United States |
| Paratek Recruiting Site | Electra | Texas | 76360 | United States |
| Paratek Recruiting Site | Houston | Texas | 77074 | United States |
| Paratek Recruiting Site | Wichita Falls | Texas | 76301 | United States |
| FG001 |
| Linezolid |
Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined. |
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| NOT COMPLETED |
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Baseline data are reported for members of the Intent-to-Treat (ITT) Population, comprised of all enrolled participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Omadacycline | Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined. |
| BG001 | Linezolid | Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | mITT Population: all enrolled participants who received at least 1 dose of test article and who had at least 1 infecting pathogen isolated at the Baseline evaluation. Non-evaluable participants are included as clinical failures. | Posted | Number | participants | 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days) |
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| Primary | 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. | CE Population: all enrolled participants who received at least 1 dose of test article and who had a qualifying skin and skin structure infection, received the correct test article for at least 5 calendar days, had the necessary clinical evaluations performed, and did not receive potentially confounding non-study antibiotics | Posted | Number | participants | 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days) |
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| Secondary | 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. | mITT Population. Non-evaluable participants are included as microbiological failures. | Posted | Number | participants | 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days) |
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| Secondary | 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. | ME Population: all participants in the CE cohort who had an infecting pathogen identified at Baseline | Posted | Number | participants | 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days) |
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from enrollment to 10 to 17 days after the last dose of test article (intravenous or oral administration) (up to approximately 27 days)
Adverse events are reported for members of the omadacycline Safety Population, comprised of all participants who received 1 or more doses of omadacycline, and members of the linezolid Safety Population, comprised of all participants who received only linezolid as intravenous test article.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omadacycline | Participants received intravenous (IV) omadacycline 100 milligrams (mg) infused over 30 minutes, every 24 hours (q24h), with the option to switch to two 100-mg capsules via oral administration q24h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined. | 0 | 111 | 1 | 111 | 44 | 111 |
| EG001 | Linezolid | Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined. | 0 | 108 | 2 | 108 | 54 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Confusional state | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Soft tissue infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Abscess | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Alanine aminotransferase (ALT) increased | Investigations | MedDRA (10.0) | Systematic Assessment |
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| Aspartate aminotransaminase (AST) increased | Investigations | MedDRA (10.0) | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA (10.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paratek Medical Information | Paratek Pharmaceuticals, Inc. | 1-833-727-2835 | medinfo@paratekpharma.com |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D017192 | Skin Diseases, Bacterial |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C545884 | 7-dimethylamino-9-(2,2-dimethylpropyl)aminomethylcycline |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Black or African American |
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| Asian Hawaiian or Other Pacific Islander |
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| American Indian or Alaska Native |
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| Recorded as Other |
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| Clinical failure: failure |
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| Clinical failure: non-evaluable |
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| OG001 | Linezolid | Participants received IV linezolid 600 mg infused over 30 minutes, every 12 hours (q12h), with the option to switch to one 600-mg tablet via oral administration q12h at the discretion of the investigator. All participants received up to 7 days of IV therapy and up to 14 days of IV and oral therapy combined. |
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