An interventional study of TORAYMYXIN PMX-20R (PMX cartridge) and Standard medical care for septic shock in Septic Shock and Endotoxemia, sponsored by Spectral Diagnostics (US) Inc.. Completed at 40 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-26.
Sponsored by Spectral Diagnostics (US) Inc. · Not applicable, Interventional, and Treatment
To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 450 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Spectral Diagnostics (US) Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard medical care for septic shock
Other: Standard medical care for septic shock
Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock
Device: TORAYMYXIN PMX-20R (PMX cartridge) · Other: Standard medical care for septic shock
TORAYMYXIN PMX-20R (PMX cartridge), Extracorporeal hemoperfusion device. 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).
Standard medical care for septic shock
Mortality
Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone
Time frame: 28 days
450 subjects randomized out of 921 clinically eligible subjects in 55 ICUs. First patient screened in Jun 2010, last patient screened in Jun 2016.
| Milestone | Sham | Treatment |
|---|---|---|
| Started | 226 | 224 |
| Completed | 226 | 223 |
| Not completed | 0 | 1 |
Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone
| Participants | Sham | Treatment |
|---|---|---|
| Mortality | 78 | 84 |
Collected over Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham | 78/226 (34.5%) | 126/220 (57.3%) | 60/220 (27.3%) |
| Treatment | 84/224 (37.5%) | 140/212 (66%) | 56/212 (26.4%) |
| Event | Sham | Treatment |
|---|---|---|
| SepsisInfections and infestations | 20/220 | 23/212 |
| Septic shockInfections and infestations | 16/220 | 13/212 |
| Multi-organ failureGeneral disorders | 12/220 | 14/212 |
| Cardiac arrestCardiac disorders | 12/220 | 6/212 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 10/220 | 8/212 |
| Cardio-respiratory arrestCardiac disorders | 8/220 | 2/212 |
| ThrombocytopeniaBlood and lymphatic system disorders | 4/220 | 6/212 |
| DeathGeneral disorders | 1/220 | 6/212 |
| Renal failure acuteRenal and urinary disorders | 6/220 | 3/212 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/220 | 5/212 |
| Event | Sham | Treatment |
|---|---|---|
| SepsisInfections and infestations | 20/220 | 23/212 |
| Septic shockInfections and infestations | 16/220 | 13/212 |
| Multi-organ failureGeneral disorders | 12/220 | 14/212 |
| Cardiac arrestCardiac disorders | 12/220 | 6/212 |
All randomized subjects had baseline assessments completed
| Age, Continuous(years) | Sham | Treatment | Total |
|---|---|---|---|
| Mean | 58.8 ± 14.7 | 60.9 ± 15.1 | 59.8 ± 14.9 |
| Sex: Female, Male(Participants) | Sham | Treatment | Total |
|---|---|---|---|
| Female | 93 | 84 | 177 |
| Male | 133 | 140 | 273 |
| Race/Ethnicity, Customized(participants) | Sham | Treatment | Total |
|---|---|---|---|
| Caucasian | 187 | 183 | 370 |
| Black | 13 | 22 | 35 |
| Hispanic | 12 | 10 | 22 |
| Asian | 9 | 3 | 12 |
| Other | 5 | 6 | 11 |
| Region of Enrollment(participants) | Sham | Treatment | Total |
|---|---|---|---|
| Canada | 57 | 53 | 110 |
| United States | 169 | 171 | 340 |
Ran from Jun 2010 to primary completion in Jul 2016, 73 months.
Results were first posted in Feb 2019, 2 years 7 months after primary completion.
Of 172 interventional studies with no phase under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 73 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Spectral Diagnostics (US) Inc.