Sepsis Clinical Trial
Official title:
Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
The purposes of this study are to determine:
1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their
condition more often or recover faster than children who do not receive drotrecogin
alfa (activated).
2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with
severe sepsis.
3. The side effects that might be associated with drotrecogin alfa (activated)
administration to children with severe sepsis.
The primary objective was to demonstrate that drotrecogin alfa (activated) compared with
placebo reduced severe-sepsis-induced organ dysfunction as assessed by time to complete
resolution of a composite of cardiovascular, respiratory, and renal organ failure in
pediatric patients with severe sepsis.
Secondary objectives included: (1) to assess whether treatment with drotrecogin alfa
(activated) reduced 28-day all-cause mortality in pediatric patients with severe sepsis
compared with placebo patients, (2) to evaluate the effects of drotrecogin alfa (activated)
on individual organ dysfunction (cardiovascular, respiratory, renal, hepatic, hematologic,
neurologic, and cutaneous), (3) to demonstrate that drotrecogin alfa (activated) improved
patient outcome as assessed by the Pediatric Overall Performance Category (POPC) scale, (4)
to demonstrate that drotrecogin alfa (activated) reduced major amputations (at or above the
wrist, at or above the ankle, face, and genitals) in pediatric patients with Neisseria
meningitidis (proven or suspected) and/or purpura fulminans, (5) to demonstrate that
drotrecogin alfa (activated) had antithrombotic and anti-inflammatory properties. The safety
objective was to evaluate whether drotrecogin alfa (activated) had an acceptable safety
profile when administered to pediatric patients with severe sepsis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05095324 -
The Biomarker Prediction Model of Septic Risk in Infected Patients
|
||
| Completed |
NCT02714595 -
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
|
Phase 3 | |
| Completed |
NCT03644030 -
Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
|
||
| Completed |
NCT02867267 -
The Efficacy and Safety of Ta1 for Sepsis
|
Phase 3 | |
| Completed |
NCT04804306 -
Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
|
||
| Recruiting |
NCT05578196 -
Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections.
|
N/A | |
| Terminated |
NCT04117568 -
The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
|
||
| Completed |
NCT03550794 -
Thiamine as a Renal Protective Agent in Septic Shock
|
Phase 2 | |
| Completed |
NCT04332861 -
Evaluation of Infection in Obstructing Urolithiasis
|
||
| Completed |
NCT04227652 -
Control of Fever in Septic Patients
|
N/A | |
| Enrolling by invitation |
NCT05052203 -
Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
|
||
| Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
| Recruiting |
NCT04005001 -
Machine Learning Sepsis Alert Notification Using Clinical Data
|
Phase 2 | |
| Completed |
NCT03258684 -
Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock
|
N/A | |
| Recruiting |
NCT05217836 -
Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
|
||
| Completed |
NCT05018546 -
Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery
|
N/A | |
| Completed |
NCT03295825 -
Heparin Binding Protein in Early Sepsis Diagnosis
|
N/A | |
| Not yet recruiting |
NCT06045130 -
PUFAs in Preterm Infants
|
||
| Not yet recruiting |
NCT05361135 -
18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia
|
N/A | |
| Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 |