Clinical trials: Systemic Inflammatory Response
Candidemia, Invasive Candidiases
An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida Auris
This is a multicenter, open-label, single arm study to evaluate the efficacy and safety of APX001 for the treatment of candidemia and/or invasive candidiasis caused by C.
- Conditions
- Candidemia, Invasive Candidiases, Candida Infection
- Trial name
- APEX (NCT04148287)
- Testing
- APX001
- Where
- 2 sites in South Africa
- Volunteers
- 9 people
- Sponsor
- Basilea Pharmaceutica
Bacteremia, Sepsis
Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala
The purpose of this study is to assess the clinical impact of a rapid multiplex PCR blood culture identification panel on time to optimal antimicrobial therapy when compared to conventional microbiological culture methods in…
- Trial name
- NCT05314816
- Testing
- Blood culture identification panel
- Where
- Guatemala
- Volunteers
- 479 people
- Sponsor
- University of Colorado, Denver
Sepsis
Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis
This study evaluates the efficacy and safety of the administration of betalactam antibiotics in prolonged infusion compared to intermittent infusion in children with sepsis.
- Trial name
- NCT03019965
- Testing
- Intermittent Piperacillin/tazobactam, Continuous Piperacillin/tazobactam, Intermittent Imipenem
- Where
- 2 sites in Mexico
- Volunteers
- 426 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Sepsis, AKI
Effect of Antibiotic Choice On ReNal Outcomes (ACORN)
Sepsis is one of the most common causes of acute illness and death in the United States. Early, empiric broad-spectrum antibiotics are a mainstay of sepsis treatment.
- Conditions
- Sepsis, AKI, Neurotoxicity
- Trial name
- ACORN (NCT05094154)
- Testing
- anti-pseudomonal cephalosporin, anti-pseudomonal penicillin
- Where
- United States
- Volunteers
- 2,634 people
- Sponsor
- Vanderbilt University Medical Center
Severe Sepsis
Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)
In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration [24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will…
- Trial name
- NCT00386425
- Testing
- Drotrecogin alfa (activated)
- Where
- 47 sites in United States, Belgium and 7 more
- Volunteers
- 486 people
- Sponsor
- Eli Lilly and Company
HIV, Acute HIV Infection
Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection
This is a multicenter, single arm, 96-week open-label study of the safety and virologic efficacy of fixed dose combination Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC FDC) initiated during acute HIV infection (AHI).
- Trial name
- PHI-05 (NCT02384395)
- Testing
- Dolutegravir 50 mg, Lamivudine 300 mg, Abacavir 600 mg
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of North Carolina, Chapel Hill
Delirium, Impaired Cognition
The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study
The long-term objective of the MIND-USA (Modifying the Impact of ICU-Induced Neurological Dysfunction-USA) Study is to define the role of antipsychotics in the management of delirium in vulnerable critically ill patients.
- Conditions
- Delirium, Impaired Cognition, Long Term Psychologic Disorders
- Trial name
- MIND-USA (NCT01211522)
- Testing
- Haloperidol, Ziprasidone
- Where
- 16 sites in United States
- Volunteers
- 566 people
- Sponsor
- Vanderbilt University Medical Center
Malaria, Seizures
Aggressive Antipyretics for Fever Reduction in CNS Malaria
The study will examine whether prophylactic and scheduled treatment with acetaminophen and ibuprofen can decrease the maximum temperature experienced during the acute illness in children with CNS malaria.
- Conditions
- Malaria, Seizures, Coma, Parasitemia
- Trial name
- NCT03399318
- Testing
- Acetaminophen, Ibuprofen
- Where
- 3 sites in Malawi, Zambia
- Volunteers
- 256 people
- Sponsor
- University of Rochester
Cytokine Release Syndrome, ICANS
Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy
This study will evaluate the use of siltuximab to decrease the severity of cytokine release syndrome (CRS) and immune effector cell-associated neurological syndrome (ICANS) in patients who will receive chimeric antigen receptor…
- Conditions
- Cytokine Release Syndrome, ICANS, Lymphoma, Non-Hodgkin, Multiple Myeloma
- Trial name
- NCT04975555
- Testing
- Siltuximab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Alabama at Birmingham
Sepsis, Severe Sepsis
Preemptive Resuscitation for Eradication of Septic Shock
The purpose of this study is to assess the ability of an empiric resuscitation strategy compared to standard care to decrease the incidence of organ failure in normotensive sepsis patients.
- Trial name
- NCT01449721
- Testing
- Intravenous fluid
- Where
- 5 sites in United States
- Volunteers
- 142 people
- Sponsor
- Christiana Care Health Services
Bacteremia
Hub Cleansing to Prevent Hub Infection
Central venous catheter infections are common preventable adverse events among hospital patients. Microbes may enter catheter hubs, also known as needleless connectors, and result in downstream contamination.
- Trial name
- HUC-PHIN (NCT01563406)
- Testing
- 15 second scrub, 5 second scrub, 3.15% chlorhexidine/70% isopropyl alcohol
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Rush University Medical Center
Fungemia, Neutropenia
An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System
The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system.
- Conditions
- Fungemia, Neutropenia, Candidiasis
- Trial name
- NCT00806351
- Testing
- Active Anidulafungin, Active Caspofungin
- Where
- 10 sites in Bosnia and Herzegovina, France and 4 more
- Volunteers
- 21 people
- Sponsor
- Pfizer
Sepsis, Hypotension
Fluid Responsiveness Evaluation in Sepsis-associated Hypotension
This study assesses the mean difference in fluid balance at ICU discharge and associated patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients with refractory hypotension in an ICU setting.
- Trial name
- FRESH (NCT02837731)
- Testing
- Treatment Starling SV monitor
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 150 people
- Sponsor
- Cheetah Medical Inc.
Sepsis
Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure.
- Trial name
- CRYSTMAS (NCT00464204)
- Testing
- 6 % Hydroxyethylstarch 130/0.4 = "Voluven®", 0.9 % NaCl
- Where
- 24 sites in France, Germany
- Volunteers
- 196 people
- Sponsor
- Fresenius Kabi
Hypotension
Efficacy Study of a Facemask Device to Treat Hypotension
The purpose of this study is to determine if the impedance threshold device (ITD) attached to a facemask can increase blood pressure in patients who present to the emergency department with hypotension secondary to hypovolemia.
- Trial name
- NCT00256724
- Testing
- Impedance Threshold Device
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Advanced Circulatory Systems
Septic Shock, Acute Kidney Injury
Renin and Renal Biomarker Response to Angiotensin II
Septic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study.
- Trial name
- NCT04558359
- Testing
- Standard of Care, Angiotensin II
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Alexander Flannery
SIRS, Sepsis
NT-proBNP in ICU Postoperative/Posttraumatic Patients With Shock
The purpose of this study is to determine the course of NT-proBNP plasma concentrations in the context of confounding parameters in postoperative/posttraumatic critically ill patients with severe SIRS/sepsis and shock.
- Conditions
- SIRS, Sepsis, Shock, Critically Ill
- Trial name
- NICUPS (NCT00736723)
- Where
- Germany
- Volunteers
- 51 people
- Sponsor
- University of Ulm
Systemic Lupus Erythematosus
A Phase II Study of M2951 in SLE
M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus…
- Trial name
- NCT02975336
- Testing
- M2951
- Where
- 157 sites in United States, Argentina and 17 more
- Volunteers
- 469 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Bacteremia, Staphylococcus Aureus
Study Evaluating Safety, Tolerability, and Efficacy of Intravenous AP-SA02 in Subjects With S. Aureus Bacteremia
Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Escalation Study of the Safety, Tolerability, and Efficacy of Intravenous AP SA02 as an Adjunct to Best Available Antibiotic Therapy Compared to…
- Conditions
- Bacteremia, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia, Bacteremia Staph
- Trial name
- diSArm (NCT05184764)
- Testing
- AP-SA02
- Where
- 28 sites in United States, Australia
- Volunteers
- 56 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi