Not provided
Not provided
Not provided
Not provided
Terminated
Not provided
| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Phase III 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-0804 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTK 0796 | Experimental | PTK 0796 100 mg for injection; PTK 0796 tablet, 300 mg (2 x 150 mg tablets) |
|
| Linezolid | Active Comparator | Gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; Gram negative treatment: moxifloxacin 400 mg tablet and moxifloxacin 400 mg IV infusion solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTK 0796 | Drug | PTK 0796 100 mg for injection; PTK 0796 tablet 150 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Classified as a Sponsor-defined Clinical Success in the Intent-to-Treat (ITT) Population at End of Treatment | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the Case Report Form (CRF) check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. | up to 14 days |
| Number of Participants Classified as a Sponsor-defined Clinical Success in the ITT Population at Test of Cure | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. | 10 to 17 days after last dose of treatment (total treatment of up to 14 days) |
| Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the Clinically Evaluable (CE) Population at End of Treatment | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Indicated Type of Adverse Event (AE) | The assessment of safety was based mainly on the frequency of AEs, and summaries of vital signs and laboratory values (values classified as AE are captured in the AE module). An AE is defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, whether or not the event was considered causally related to the medical product. An AE could have been a new occurrence or an existing process that increased in intensity or frequency. AEs were deemed treatment-emergent if the start date was on or after the date of the first dose but was not present before that date or if the AE started before the date of the first dose and increased in severity on or after that date. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mary West | Paratek Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paratek Recruiting Site | Fountain Valley | California | 92708 | United States | ||
| Parateck Recruiting Site |
Participants who met inclusion criteria and did not meet exclusion criteria were randomly assigned to a treatment group.
The study was designed to enroll adult participants with Complicated Skin and Skin Structure Infection (CSSI). Participants were stratified at study entry by type of infection (i.e., wound infection, cellulitis, major abscess).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Omadacycline | Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 24 hours (q24h) for up to 4 to 7 days, then received a 300 mg oral administration q24h. The total treatment duration was up to 14 days. To maintain the blind, participants received an omadacycline infusion alternating with a placebo infusion q12h. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| linezolid | Drug | For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600 mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution |
|
|
| moxifloxacin | Drug | moxifloxacin 400 mg tablet; moxifloxacin 400 mg IV infusion solution |
|
| up to 14 days |
| Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at End of Treatment | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. | up to 14 days |
| Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. | 10 to 17 days after last dose of treatment (total treatment of up to 14 days) |
| Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. | 10 to 17 days after last dose of treatment (total treatment of up to 14 days) |
| from the time of informed consent to Test of Cure (10 to 17 days after end of treatment [total treatment of up to 14 days) |
| La Mesa |
| California |
| 91942 |
| United States |
| Paratek Recruiting Site | Oceanside | California | 92056 | United States |
| Paratek Recruiting Site | San Diego | California | 92114 | United States |
| Paratek Recruiting Site | San Jose | California | 95154 | United States |
| Parateck Recruiting Site | Columbus | Georgia | 31904 | United States |
| Paratek Recruiting Site | Savannah | Georgia | 31406 | United States |
| FG001 |
| Linezolid |
Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat Population: all enrolled participants who received at least one dose of study medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Omadacycline | Participants received intravenous (IV) omadacycline 100 milligrams (mg) every 24 hours (q24h) for up to 4 to 7 days, then received a 300 mg oral administration q24h. The total treatment duration was up to 14 days. To maintain the blind, participants received an omadacycline infusion alternating with a placebo infusion q12h. |
| BG001 | Linezolid | Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 Classified as a Sponsor-defined Clinical Success in the Intent-to-Treat (ITT) Population at End of Treatment | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the Case Report Form (CRF) check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. | Intent-to-Treat (ITT) Population: all enrolled participants who received at least one dose of study medication. Participants were analyzed for efficacy according to randomization, regardless of treatment administered. | Posted | Count of Participants | Participants | up to 14 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Classified as a Sponsor-defined Clinical Success in the ITT Population at Test of Cure | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. | ITT Population | Posted | Count of Participants | Participants | 10 to 17 days after last dose of treatment (total treatment of up to 14 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the Clinically Evaluable (CE) Population at End of Treatment | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. | CE Population: all participants in the ITT Population who met specific criteria such that the clinical outcome of their infection could be inferred to reflect the effect of the study drug. Only those participants stratified with wound infection at study entry were analyzed. | Posted | Count of Participants | Participants | up to 14 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at End of Treatment | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. | CE Population: all participants in the ITT Population who met specific criteria such that the clinical outcome of their infection could be inferred to reflect the effect of the study drug. Only those participants stratified with cellulitis at study entry were analyzed. | Posted | Count of Participants | Participants | up to 14 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Wound Infections Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. | CE Population: all participants in the ITT Population who met specific criteria such that the clinical outcome of their infection could be inferred to reflect the effect of the study drug. Only those participants stratified with wound infection at study entry were analyzed. | Posted | Count of Participants | Participants | 10 to 17 days after last dose of treatment (total treatment of up to 14 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Cellulitis Classified as a Sponsor-defined Clinical Success in the CE Population at Test of Cure | Sponsor-defined clinical success is defined as at least 72 hours of study drug and antibiotics not needed/infection sufficiently resolved. If a participant received antibiotics for a different infection after the primary qualifying infection was considered cured/largely resolved as per the investigator on the CRF check box, the participant was also considered as a sponsor-defined clinical success. Sponsor-defined clinical failures must have at least 48 hours of study drug in order to be considered a failure. The sponsor classified participants as clinical failures based on the following: 1) minimum duration of treatment required for outcomes evaluation, 2) use of pre-study antibiotics, 3) use of potentially confounding systemic antibiotics during the study, and 4) timing of concomitant curative surgical procedures. | CE Population: all participants in the ITT Population who met specific criteria such that the clinical outcome of their infection could be inferred to reflect the effect of the study drug. Only those participants stratified with cellulitis at study entry were analyzed. | Posted | Count of Participants | Participants | 10 to 17 days after last dose of treatment (total treatment of up to 14 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Indicated Type of Adverse Event (AE) | The assessment of safety was based mainly on the frequency of AEs, and summaries of vital signs and laboratory values (values classified as AE are captured in the AE module). An AE is defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, whether or not the event was considered causally related to the medical product. An AE could have been a new occurrence or an existing process that increased in intensity or frequency. AEs were deemed treatment-emergent if the start date was on or after the date of the first dose but was not present before that date or if the AE started before the date of the first dose and increased in severity on or after that date. | Safety Population: all enrolled participants who received at least one dose of study medication | Posted | Count of Participants | Participants | from the time of informed consent to Test of Cure (10 to 17 days after end of treatment [total treatment of up to 14 days) |
|
from the time of informed consent to Test of Cure (10 to 17 days after end of treatment [total treatment of up to 14 days])
Adverse events are reported for members of the Safety Population, comprised of all enrolled participants who received at least one dose of study medication
Not provided
| 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) every 24 hours (q24h) for up to 4 to 7 days, then received a 300 mg oral administration q24h. The total treatment duration was up to 14 days. To maintain the blind, participants received an omadacycline infusion alternating with a placebo infusion q12h. | 1 | 68 | 3 | 68 | 52 | 68 |
| EG001 | Linezolid | Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections. | 0 | 72 | 1 | 72 | 55 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
Changes in Food and Drug Administration (FDA) criteria for the identification and enrollment of participants with complicated skin and skin structure infections as well as the primary endpoint led to administrative termination of the study.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paratek Medical Information | Paratek Pharmaceuticals, Inc. | 1-833-727-2835 | medinfo@paratekpharma.com |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D000038 | Abscess |
| D014947 | Wounds and Injuries |
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C545884 | 7-dimethylamino-9-(2,2-dimethylpropyl)aminomethylcycline |
| C000591640 | omadacycline |
| D000069349 | Linezolid |
| D000077266 | Moxifloxacin |
| 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 |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| >64 |
|
| Male |
|
| Black |
|
| Asian |
|
| Pacific Islander |
|
| Other; Not Specified |
|
| Clinical non-evaluable |
|
Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections.
|
|
|
| OG001 | Linezolid | Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections. |
|
|
|
| OG001 | Linezolid | Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections. |
|
|
|
| OG001 | Linezolid | Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections. |
|
|
|
| OG001 | Linezolid | Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections. |
|
|
|
Participants received IV linezolid 600 mg every 12 hours (q12h) for up to 4 to 7 days, then received a 600 mg oral administration q12h. The total treatment duration was up to 14 days. Participants received moxifloxacin 400 mg q24, IV or oral administration, as appropriate to accompany linezolid for suspected or confirmed gram-negative infections.
|
|