Trial · NCT02469857
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE) | 28 days | NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure (i.e., a "responder"): (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. This analysis compared responders in the reltecimod group versus responders in the placebo group. Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure. |
| Secondary | Number of Patients With One or More Adverse Events (AEs) | 28 days | Number of Patients With One or More Adverse Events (AEs). Serious Adverse Events (SAEs) are included in this outcome measure since SAEs are a subset of AEs. |
| Secondary | Number of Patients With One or More Serious Adverse Events (SAEs) | 28 days | Number of Patients with One or More Serious Adverse Events (SAEs) During the Study |
| Secondary | Number of Patients With One or More Secondary Infections | 28 days | Number of Patients with One or More Secondary Infections During the Study |
| Secondary | Number of Patients Achieving Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1 | 14 days | Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure. |
| Secondary | Intensive Care Unit (ICU)-Free Days | 28 days | ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28. |
| Secondary | Ventilator-free Days | 28 days | Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28. |
| Secondary | Vasopressor-free Days | 28 days | Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28. |
| Secondary | Hospital Days | 90 days or until end of follow up | Hospital days refers to the number of days a patient spent time in the hospital. |
| Secondary | Number of Patients With a More Favorable or Less Favorable Hospital Discharge Location | 90 days | Number of patients with more favorable discharge location (home or rehabilitation facility) or less favorable discharge location (skilled nursing facility, another acute care facility, death, other) |
| Other | Number of Deaths From Day 0 Through Day 90 | 90 days | The number of deaths occurring from Study Day 0 through Study Day 90 |
| Other | Number of Deaths After Day 14 Through Day 90 | 76 days (after Day 14 through Day 90) | Number of deaths after Study Day 14 through Study Day 90 |
| Other | Number of Deaths From Day 0 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5 | 90 days | Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 0 and subsequently died through Study Day 90. |
| Other | Number of Deaths After Day 14 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5 | 76 days (after Day 14 through Day 90) | Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 14 and subsequently died through Study Day 90. |
| Other | Number of Deaths From Day 0 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock) | 90 days | Number and percentage of patients with baseline cardiovascular failure (shock) who died through Study Day 90. |
| Other | Number of Deaths After Day 14 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock) | 76 days (after Day 14 through Day 90) | Number and percentage of patients with baseline cardiovascular failure (shock) who were alive on Study Day 14 and subsequently died through Study Day 90. |
| Other | Number of Patients With a Screening Modified Sequential Organ Failure Assessment (mSOFA) Score of at Least 5 Who Achieved NICCE | 28 days | NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure. |
| Other | Number of Patients With a Screening mSOFA Score of at Least 5 Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1 | 14 days | Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure. |
| Other | Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved NICCE | 28 days | NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. |
| Other | Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1 | 14 days | Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02469857/registered