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| ID | Type | Description | Link |
|---|---|---|---|
| TR701-132 | Other Identifier | Cubist Protocol Number | |
| 2013-004154-22 | EudraCT Number | ||
| MK-1986-002 | Other Identifier | Merck Protocol Number |
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This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3 study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days versus linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the treatment of ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), collectively referred to as ventilated nosocomial pneumonia (VNP). Participants with concurrent gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm.
The primary objective is to determine the noninferiority (NI) in all-cause mortality (ACM) within 28 days after randomization of IV tedizolid phosphate compared with IV linezolid in the Intent to Treat (ITT) Analysis Set (NI is declared when the lower bound of the 95% CI > -10).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tedizolid phosphate IV | Experimental | Ventilated HABP/VABP participants receive tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia. |
|
| Linezolid IV | Active Comparator | Ventilated HABP/VABP participants receive linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tedizolid phosphate | Drug | Tedizolid phosphate IV 200 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population | The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population | The numbers of participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. | Up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16600048 | Background | Alp E, Voss A. Ventilator associated pneumonia and infection control. Ann Clin Microbiol Antimicrob. 2006 Apr 6;5:7. doi: 10.1186/1476-0711-5-7. | |
| 15699079 | Background | American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available. |
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Ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) were enrolled at study sites located in 34 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tedizolid | Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia. |
| FG001 | Linezolid | Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tedizolid | Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia. |
| BG001 | Linezolid | Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 All-Cause Mortality in the Intent-to-Treat (ITT) Population | The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. | The ITT set is all randomized participants. | Posted | Count of Participants | Participants | Up to 28 days |
|
Up to 32 days
All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.
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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 | Tedizolid | Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2018 | Jun 10, 2019 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C515040 | tedizolid phosphate |
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
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| Linezolid | Drug | Linezolid IV 600 mg twice daily |
|
|
| Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population | The clinical response in the ITT population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP. | 7-14 days after end of therapy - TOC |
| Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population | The clinical response in the CE population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP. | 7-14 days after end of therapy - TOC |
| Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population | The number of MSSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MSSA culture results from respiratory tract or pleural fluid specimens obtained within 36 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. | Up to 28 days |
| Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population | The number of MRSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MRSA culture results from respiratory tract or pleural fluid specimens obtained within 72 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. | Up to 28 days |
| Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population | The number of patients in the mITT population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). | 1-3 days after completing study therapy (Days 8-10 or Days 15-17) |
| Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population | The number of patients in the ME-1 population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). | 1-3 days after completing study therapy (Days 8-10 or Days 15-17) |
| Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population | The number of patients in the mITT population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). | 7-14 days after end of therapy - TOC |
| Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population | The number of patients in the ME-2 population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). | 7-14 days after end of therapy - TOC |
| Number of Participants With ≥1 Adverse Events (AEs) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis is based on actual treatment received instead of randomization. | Up to 32 days |
| Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis was based on actual treatment received and not randomization. | Up to 14 days |
| 14625336 | Background | Chastre J, Wolff M, Fagon JY, Chevret S, Thomas F, Wermert D, Clementi E, Gonzalez J, Jusserand D, Asfar P, Perrin D, Fieux F, Aubas S; PneumA Trial Group. Comparison of 8 vs 15 days of antibiotic therapy for ventilator-associated pneumonia in adults: a randomized trial. JAMA. 2003 Nov 19;290(19):2588-98. doi: 10.1001/jama.290.19.2588. |
| 3390511 | Background | Lan KK, Wittes J. The B-value: a tool for monitoring data. Biometrics. 1988 Jun;44(2):579-85. |
| 16652315 | Background | Lawrence KR, Adra M, Gillman PK. Serotonin toxicity associated with the use of linezolid: a review of postmarketing data. Clin Infect Dis. 2006 Jun 1;42(11):1578-83. doi: 10.1086/503839. Epub 2006 Apr 27. |
| 19759040 | Background | Lemaire S, Van Bambeke F, Appelbaum PC, Tulkens PM. Cellular pharmacokinetics and intracellular activity of torezolid (TR-700): studies with human macrophage (THP-1) and endothelial (HUVEC) cell lines. J Antimicrob Chemother. 2009 Nov;64(5):1035-43. doi: 10.1093/jac/dkp267. Epub 2009 Sep 16. |
| 18989656 | Background | Torres A, Ewig S, Lode H, Carlet J; European HAP working group. Defining, treating and preventing hospital acquired pneumonia: European perspective. Intensive Care Med. 2009 Jan;35(1):9-29. doi: 10.1007/s00134-008-1336-9. Epub 2008 Nov 7. |
| 21911576 | Background | Drusano GL, Liu W, Kulawy R, Louie A. Impact of granulocytes on the antimicrobial effect of tedizolid in a mouse thigh infection model. Antimicrob Agents Chemother. 2011 Nov;55(11):5300-5. doi: 10.1128/AAC.00502-11. Epub 2011 Sep 12. |
| 21555763 | Background | Garonzik SM, Li J, Thamlikitkul V, Paterson DL, Shoham S, Jacob J, Silveira FP, Forrest A, Nation RL. Population pharmacokinetics of colistin methanesulfonate and formed colistin in critically ill patients from a multicenter study provide dosing suggestions for various categories of patients. Antimicrob Agents Chemother. 2011 Jul;55(7):3284-94. doi: 10.1128/AAC.01733-10. Epub 2011 May 9. |
| 21217178 | Background | Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children: executive summary. Clin Infect Dis. 2011 Feb 1;52(3):285-92. doi: 10.1093/cid/cir034. |
| 21163725 | Background | Pletz MW, Burkhardt O, Welte T. Nosocomial methicillin-resistant Staphylococcus aureus (MRSA) pneumonia: linezolid or vancomycin? - Comparison of pharmacology and clinical efficacy. Eur J Med Res. 2010 Nov 30;15(12):507-13. doi: 10.1186/2047-783x-15-12-507. |
| 22354302 | Background | Tessier PR, Keel RA, Hagihara M, Crandon JL, Nicolau DP. Comparative in vivo efficacies of epithelial lining fluid exposures of tedizolid, linezolid, and vancomycin for methicillin-resistant Staphylococcus aureus in a mouse pneumonia model. Antimicrob Agents Chemother. 2012 May;56(5):2342-6. doi: 10.1128/AAC.06427-11. Epub 2012 Feb 21. |
| 22247123 | Background | Wunderink RG, Niederman MS, Kollef MH, Shorr AF, Kunkel MJ, Baruch A, McGee WT, Reisman A, Chastre J. Linezolid in methicillin-resistant Staphylococcus aureus nosocomial pneumonia: a randomized, controlled study. Clin Infect Dis. 2012 Mar 1;54(5):621-9. doi: 10.1093/cid/cir895. Epub 2012 Jan 12. |
| 35718656 | Derived | Mikamo H, Nagashima M, Kusachi S, Fujimi S, Oshima N, De Anda C, Takase A. Efficacy and safety of tedizolid for the treatment of ventilated gram-positive hospital-acquired or ventilator-associated bacterial pneumonia in Japanese patients: Results from a subgroup analysis of a phase 3, randomized, double-blind study comparing tedizolid and linezolid. J Infect Chemother. 2022 Sep;28(9):1235-1241. doi: 10.1016/j.jiac.2022.04.027. Epub 2022 Jun 16. |
| 33720350 | Derived | Wunderink RG, Roquilly A, Croce M, Rodriguez Gonzalez D, Fujimi S, Butterton JR, Broyde N, Popejoy MW, Kim JY, De Anda C. A Phase 3, Randomized, Double-Blind Study Comparing Tedizolid Phosphate and Linezolid for Treatment of Ventilated Gram-Positive Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia. Clin Infect Dis. 2021 Aug 2;73(3):e710-e718. doi: 10.1093/cid/ciab032. |
| At request of sponsor or investigator |
|
| Death |
|
| Transferred to other care facility |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population | The numbers of participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. | The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if methicillin-resistant S. aureus [MRSA]) before first study drug dose, and bacterial pathogen against which the investigational drug has antibacterial activity. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
|
| Secondary | Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population | The clinical response in the ITT population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP. | The ITT set includes all randomized participants. | Posted | Count of Participants | Participants | 7-14 days after end of therapy - TOC |
|
|
|
|
| Secondary | Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population | The clinical response in the CE population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP. | The CE set is all randomized and treated participants who had assessment data available and did not have confounding events. | Posted | Count of Participants | Participants | 7-14 days after end of therapy - TOC |
|
|
|
|
| Secondary | Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population | The number of MSSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MSSA culture results from respiratory tract or pleural fluid specimens obtained within 36 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. | The MSSA-infected mITT set is all randomized, treated participants who have MSSA confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
|
| Secondary | Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population | The number of MRSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MRSA culture results from respiratory tract or pleural fluid specimens obtained within 72 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased. | The MRSA-infected mITT set is all randomized, treated participants who have MRSA confirmed by respiratory tract/pleural fluid culture results obtained within 72 hours before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity. | Posted | Count of Participants | Participants | Up to 28 days |
|
|
|
|
| Secondary | Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population | The number of patients in the mITT population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). | The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if MRSA) before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity. | Posted | Count of Participants | Participants | 1-3 days after completing study therapy (Days 8-10 or Days 15-17) |
|
|
|
|
| Secondary | Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population | The number of patients in the ME-1 population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). | The ME-1 set is all mITT participants who did not receive an antibiotic (other than study drug) with activity against the baseline pathogen up to 28 days after randomization. | Posted | Count of Participants | Participants | 1-3 days after completing study therapy (Days 8-10 or Days 15-17) |
|
|
|
|
| Secondary | Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population | The number of patients in the mITT population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). | The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if MRSA) before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity. | Posted | Count of Participants | Participants | 7-14 days after end of therapy - TOC |
|
|
|
|
| Secondary | Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population | The number of patients in the ME-2 population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator). | The ME-2 set is all mITT participants who did not receive an antibiotic (other than study drug) with activity against the baseline pathogen up to the TOC visit and is also in the clinically-evaluable (CE) set. | Posted | Count of Participants | Participants | 7-14 days after end of therapy - TOC |
|
|
|
|
| Secondary | Number of Participants With ≥1 Adverse Events (AEs) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis is based on actual treatment received instead of randomization. | The safety set is all randomized participants who received any amount of study drug. A total of 4 participants were randomized to tedizolid but received linezolid. | Posted | Count of Participants | Participants | Up to 32 days |
|
|
|
| Secondary | Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis was based on actual treatment received and not randomization. | The safety set is all randomized participants who received any amount of study drug. A total of 4 participants were randomized to tedizolid but received linezolid. | Posted | Count of Participants | Participants | Up to 14 days |
|
|
|
| 101 |
| 357 |
| 129 |
| 357 |
| 176 |
| 357 |
| EG001 | Linezolid | Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia. | 103 | 361 | 149 | 361 | 175 | 361 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pulseless electrical activity | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Glossoptosis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pancreatic necrosis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Brain death | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sudden cardiac death | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Systemic inflammatory response syndrome | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acinetobacter bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Brain abscess | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| CNS ventriculitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Empyema | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Endotoxaemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Endotoxic shock | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Enterobacter pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Fungaemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Meningitis bacterial | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia acinetobacter | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Toxic shock syndrome | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Tracheostomy malfunction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Propofol infusion syndrome | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cerebellopontine angle tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Chronic myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Amyotrophic lateral sclerosis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Benign enlargement of the subarachnoid spaces | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Brain hypoxia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Brain injury | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cerebral vasoconstriction | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cholinergic syndrome | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Coma | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myasthenia gravis crisis | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Stroke in evolution | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pharyngeal haematoma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pleural thickening | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Penile ulceration | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Extremity necrosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haemodynamic instability | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Neurogenic shock | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
Cubist intends to pursue publication of the results of the study in cooperation with a lead Investigator, subject to the terms and conditions of the clinical study agreement between Cubist and Investigators. Cubist approval in writing is required for publication of any data subsets.
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Indeterminate |
|
| Indeterminate |
|