Spectral Medical Inc T.EDT

RE:I'd say "send in the clowns" ...but they've been "ordered" .

[SouthernTierTom]

Here is the most current UPdate screen from US Trials.gov here in the US;

**** IMPORTANT**** although it is said that the phase 3B confirmatory TIGRIS is supposed to be an  exstention of the phase 3 Euphrates..DO NOTE that the title changed so that "septic shock" has now become "Endotoxemic Septic Shock"

Our most important VP and key pioneer in our multi-decade fight to solve "Endotoxemic Septic Shock" REMAINS the FDA contact as at March 22 / 2022 ... this sum 3 months AFTER her "retirement"??

Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study (TIGRIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

 

ClinicalTrials.gov Identifier: NCT03901807

Recruitment Status  : Recruiting

First Posted  : April 3, 2019

Last Update Posted  : March 22, 2022

See Contacts and Locations

Sponsor:

Spectral Diagnostics (US) Inc.

Information provided by (Responsible Party):

Spectral Diagnostics (US) Inc.

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Study Description

 

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Brief Summary:

Prospective, multicenter, randomized, open-label study of standard of care plus the PMX cartridge versus standard of care alone in patients with endotoxemic septic shock

Condition or disease	Intervention/treatment	Phase
Septic ShockEndotoxemia	Device: Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge	Not Applicable

Expanded Access : An investigational treatment associated with this study is temporarily not available outside the clinical trial.   More info ...

Detailed Description:

This is a prospective, multicenter, randomized, open-label trial of standard medical care plus the PMX cartridge versus standard medical care alone, in subjects with endotoxemia and septic shock. Subjects in critical care areas will be assessed for septic shock using known or suspected infection, multiple organ failure, fluid resuscitation and hypotension requiring vasopressor support as primary criteria. Subjects will meet all entry criteria for study if endotoxin activity is within the range of ≥ 0.60 to <0.90.

Eligible and consented subjects will be randomized to receive either the PMX cartridge (administered twice for 1½ to 2 hours per treatment session approximately 24 hours apart) plus standard medical care or standard medical care alone. For all randomized subjects, a follow-up visit (if they are still in the hospital) or a telephone call will be completed at Day 28 (or later) to determine their mortality status. In surviving subjects, a follow-up visit or telephone call to determine their mortality status will also take place at approximately three months (i.e. Day 90) and 12 months after the subject was randomized.

Study Design

 

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Study Type  :	Interventional  (Clinical Trial)
Estimated Enrollment  :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	The subjects will be randomized in a 2:1 ratio to the two groups (PMX cartridge plus standard of care: standard of care alone). A blocked randomization scheme will be used to provide approximately balanced ratio allocations to the two groups for each investigative site during the study.
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients With Endotoxemic Septic Shock
Actual Study Start Date  :	October 17, 2019
Estimated Primary Completion Date  :	June 30, 2023
Estimated Study Completion Date  :	June 30, 2024

 

Resource links provided by the National Library of Medicine

 

 

MedlinePlus related topics: Shock

U.S. FDA Resources

Arms and Interventions

 

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Arm	Intervention/treatment
Experimental: PMX Treatment Standard medical care for septic shock plus treatment with the PMX cartridge (twice approximately 24 hours apart)	Device: Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge TORAYMYXIN PMX-20R (PMX) is an extracorporeal hemoperfusion cartridge intended for the selective removal of endotoxin from circulating blood through direct hemoperfusion (DHP). Each treatment will target 2 hours with a minimum of 1 ½ hours, at a flow rate of approximately 100 mL/minute, (range of 80 to 120 mL/minute).
No Intervention: Control Standard medical care alone

Outcome Measures

 

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Primary Outcome Measures  :

1. Day 28 mortality comparison [ Time Frame: 28 days ]
   The primary objective is to compare the safety and efficacy of the PMX cartridge (Toraymyxin) based on mortality at 28 days in patients with septic shock and endotoxemia who are treated with standard medical care plus the use of the PMX cartridge, versus patients who receive standard medical care alone.

Secondary Outcome Measures  :

1. MAP comparison [ Time Frame: 3 days ]
   compare changes in mean arterial blood pressure (MAP) from Day 0 to Day 3 in each group
2. Vasopressor dose comparison [ Time Frame: 3 days ]
   compare the changes in vasopressor doses from Day 0 to Day 3 in each group
3. Survival time comparison [ Time Frame: 28 days ]
   compare the survival time from baseline to death within 28 days in each group
4. Day 28 mortality comparison for patients on norepinephrine >0.1 mcg/kg/min [ Time Frame: 28 days ]
   compare mortality at 28 days post baseline for patients with baseline norepinephrine dose >0.1 mcg/kg/min in each group
5. Day 14 mortality comparison [ Time Frame: 14 days ]
   compare mortality at 14 days post baseline in each group
6. Vasopressor use comparison [ Time Frame: 3 days ]
   compare total duration of vasopressor use from Day 0 to Day 3 in each group

Eligibility Criteria

 

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Information from the National Library of Medicine

 

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:	18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Age ≥18 years of age

2. Hypotension requiring vasopressor support: Requirement for at least one of the vasopressors listed below, at the dose shown below, for at least 2 continuous hours and no more than 30 hours

   1. Norepinephrine > 0.05mcg/kg/min
   2. Dopamine > 10 mcg/kg/min
   3. Phenylephrine > 0.4 mcg/kg/min
   4. Epinephrine > 0.05 mcg/kg/min
   5. Vasopressin > 0.03 units/min
   6. Vasopressin (any dose) in combination with another vasopressor listed above
3. The subject must have received intravenous fluid resuscitation of a minimum of 30mL/kg administered within 24 hours of eligibility
4. Documented or suspected infection defined as definitive or empiric intravenous antibiotic administration
5. The subject must have a screening multi-organ dysfunction score (MODS) >9 OR a sequential organ failure assessment (SOFA) >11, in the event a complete MODS cannot be obtained due to missing measurements
6. Endotoxin Activity Assay between ≥ 0.60 to <0.90 EA units

7. Evidence of at least 1 of the following criteria for new onset organ dysfunction that is considered to be due to the acute illness:

   1. Requirement for positive pressure ventilation via an endotracheal tube or tracheostomy tube
   2. Thrombocytopenia defined as acute onset of platelet count <150,000µ/L or a reduction of 50% from prior known levels
   3. Acute oliguria defined as urine output <0.5mL/kg/hr for at least 6 hours despite adequate fluid resuscitation

Exclusion Criteria:

1. Inability to obtain an informed consent from the subject, family member or an authorized surrogate
2. Lack of commitment for full medical support
3. Inability to achieve or maintain a minimum mean arterial pressure (MAP) of ≥ 65mmHg despite vasopressor therapy and fluid resuscitation
4. Subject has end-stage renal disease and requires chronic dialysis

5. There is clinical support for non-septic shock such as:

   1. Acute pulmonary embolus
   2. Transfusion reaction
   3. Severe congestive heart failure (e.g. NYHA Class IV, ejection fraction < 35%)
6. Subject has had chest compressions as part of CPR during this hospitalization without immediate return to communicative state
7. Subject has had an acute myocardial infarction (AMI) within the past 4 weeks
8. Subject has uncontrolled hemorrhage (acute blood loss requiring > 3 UPC in the past 24 hours)
9. Major trauma within 36 hours of screening
10. Subject has severe granulocytopenia (leukocyte count less than 500 cells/mm3) or severe thrombocytopenia (platelet count less than 30,000 cells/mm3)
11. HIV infection in association with a last known or suspected CD4 count of <50/mm3
12. Subject's baseline state is non-communicative
13. Subject has sustained extensive third-degree burns within the past 7 days
14. Body weight < 35 kg (77 pounds)
15. Known hypersensitivity to Polymyxin B
16. Subject has known sensitivity or allergy to heparin or has a history of heparin associated thrombocytopenia (H.I.T.)
17. Subject is currently enrolled in an investigational drug or device trial
18. Subject has been previously enrolled in the current trial
19. Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate for enrollment, such as end-stage chronic illness (eg. lack of source control and bowel necrosis) with no reasonable expectation of survival to hospital discharge

Contacts and Locations

 

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Information from the National Library of Medicine

 

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901807

Contacts

Contact: Debra Foster	416-626-3233 ext 2001	[e-mail]

Locations

 Show 17 study location