Sepsis Clinical Trial
Severe sepsis is defined as a systemic inflammatory response syndrome that results from infection and is associated with acute organ dysfunction. It usually results from bacterial infections, but it may occur in response to other pathogens, such as fungi, viruses, and parasites.
Drotrecogin alfa (activated), a recombinant form of human activated protein C, is the first
therapeutic intervention shown to reduce all-cause mortality in severe sepsis. In the Phase
3 study (F1K-MC-EVAD; PROWESS), 1690 patients were randomly assigned to receive a 96-hour
intravenous infusion of drotrecogin alfa (activated) 24 micrograms/kg/h or placebo (850
patients and 840 patients, respectively). Overall, administration of drotrecogin alfa
(activated) yielded a clinically significant reduction in 28-day all-cause mortality: 24.7%
of drotrecogin alfa (activated) patients died versus 30.8% of placebo patients (19.4%
relative risk reduction; p=0.005; Bernard et al. 2001). The only safety concern noted in the
Phase 3 trial was an increased risk of serious bleeding among drotrecogin alfa (activated)
patients (3.5% versus 2.0% of placebo patients). The difference between the two treatment
groups in the number of patients who experienced a serious bleeding event was due to the
greater number of drotrecogin alfa (activated) patients who experienced a serious bleeding
event that was related to a procedure (for example, bleeding that resulted from the
placement of a catheter or nephrostomy tube). The number of patients who experienced
spontaneous serious bleeding events was similar between the two treatment groups.
The Regulatory authorities have approved the use of drotrecogin alfa (activated) in severe
sepsis patients with a high level of disease severity and risk of death. Thus, the
regulatory authorities have requested a study evaluating drotrecogin alfa (activated) in a
specific subpopulation of patients with severe sepsis and at lower risk of death.
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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 |