Clinical trials: Systemic Infection
Septic Shock, Critical Illness
Evaluation of Hydrocortisone, Vitamin C and Thiamine for the Treatment of Septic Shock
Despite recent medical advances, sepsis and septic shock remain a major cause of death. Sepsis is a syndrome with a wide array of physiologic, pathologic, and biochemical abnormalities.
- Trial name
- HYVITS (NCT03380507)
- Testing
- Triple therapy group
- Where
- Qatar
- Volunteers
- 106 people
- Sponsor
- Hamad Medical Corporation
Sepsis, Systemic Inflammatory Response Syndrome (SIRS)
Effect of Lactiplantibacillus Plantarum DAD-13 on Inflammatory Markers in ICU Sepsis Patients
This study investigated whether giving the probiotic Lactiplantibacillus plantarum DAD-13 to sepsis patients in the intensive care unit (ICU) could help reduce inflammation and improve bowel function.
- Conditions
- Sepsis, Systemic Inflammatory Response Syndrome (SIRS), Critical Illness
- Trial name
- LactoSepsis (NCT07072871)
- Testing
- Lactiplantibacillus plantarum DAD-13
- Where
- Indonesia
- Volunteers
- 32 people
- Sponsor
- PT Royal Medikalink Pharmalab
Systemic Fungal Infections
Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
This multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents from 2005 through 2012 with…
- Trial name
- MYCOS (NCT01686607)
- Testing
- Parenteral micafungin application, Other parenteral antifungal drugs
- Where
- 6 sites in United States
- Volunteers
- 40,110 people
- Sponsor
- Astellas Pharma Europe B.V.
Infection
Procurement of Human Specimens for the Evaluation of Early Markers of Sepsis
Procure blood specimens from individuals presenting to the emergency department (ED) with signs and /or symptoms of systemic infection or sepsis.
- Trial name
- EMOS (NCT01746407)
- Where
- 2 sites in United States
- Volunteers
- 872 people
- Sponsor
- Abbott Diagnostics Division
Pneumonia, Bacterial
Study Evaluating Streptococcus Pneumoniae Serotype Carriage Rate for Nasopharyngeal Carriage in Filipino Children
Evaluation of the carriage rate of Streptococcus pneumoniae in the nasopharynx of healthy children and the carriage rate and distribution of Streptococcus pneumoniae serotypes
- Trial name
- NCT00724828
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Acute Renal Failure
Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure
Although conventional hemodialysis removes waste products and corrects fluid imbalance, it does not replace critical absorptive, metabolic, endocrine, and immunologic functions performed by healthy renal tubule cells.
- Trial name
- NCT00511407
- Testing
- Renal tubule assist device
- Where
- 13 sites in United States
- Volunteers
- 58 people
- Sponsor
- RenaMed Biologics
Systemic Lupus Erythematosus
This Project Aims to Understand the Needs of Rheumatologists and Other Specialties in the Care of Patients With SLE
The project will be conducted in four distinct stages. Firstly, evidence synthesis will be carried out to gather and analyze available data on the topic.
- Trial name
- LESBRA (NCT06698900)
- Where
- Brazil
- Volunteers
- 1,000 people
- Sponsor
- AstraZeneca
Low Gelsolin, Trauma
Ascending Single Dose Study of Rhu-pGelsolin in Patients With Decreased Gelsolin Levels
This study is designed to assess the pharmacokinetics and safety of an infusion of a single dose of recombinant plasma gelsolin (rhu-pGelsolin) when given to patients admitted to the Intensive Care Unit with documented low levels…
- Conditions
- Low Gelsolin, Trauma, Infection, Burns
- Trial name
- NCT00671307
- Testing
- rhu-pGelsolin
- Where
- Hong Kong
- Volunteers
- 40 people
- Sponsor
- Critical Biologics Corporation
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.
Staphylococcus Aureus Bacteremia
Clinical Trial Comparing Safety and Pharmacokinetics of Standard Antibiotic Therapy, Plus Aurexis® or Placebo, for Treatment of Staphylococcus Aureus Bacteremia (SAB)
Hospitalized patients at least 18 years of age, with Staphylococcus aureus bacteremia (SAB) will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57.
- Trial name
- NCT00198302
- Testing
- Aurexis®
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Invasive Fungal Infections
Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
The aim of the study is to prospectively evaluate the safety and efficacy of micafungin when prescribed for prophylaxis or treatment of fungal infections in different real-world clinical conditions and centers, in pediatric…
- Trial name
- NCT03174457
- Testing
- Micafungin
- Where
- 16 sites in Hong Kong, Singapore and 3 more
- Volunteers
- 120 people
- Sponsor
- Astellas Pharma Singapore Pte. Ltd.
Candidemia
An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in…
- Trial name
- NCT03604705
- Testing
- APX001
- Where
- 29 sites in United States, Belgium and 3 more
- Volunteers
- 21 people
- Sponsor
- Basilea Pharmaceutica
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.
Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
- Conditions
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
- Trial name
- NCT05121753
- Testing
- Survey investigating Infant formula feeding in newborns
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Neuroganics LLC
Sepsis, Severe
Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy
Evaluation of a novel therapy approach for severe sepsis patients. Subjects randomized into the treatment arm receive treatment with an immune cell perfusion system on top of standard care.
- Trial name
- ReActiF-ICE (NCT05442710)
- Testing
- ARTICE
- Where
- 20 sites in Germany
- Volunteers
- 142 people
- Sponsor
- Artcline GmbH
Sepsis, Acute Kidney Injury
A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.
This study will enroll adults aged 18 to 80 years diagnosed with sepsis due to a suspected or confirmed bacterial infection, within 7 days of being admitted to the hospital, and who have also developed acute kidney injury within…
- Trial name
- SERENIA (NCT07215702)
- Testing
- AZD4144
- Where
- 74 sites in United States, Argentina and 12 more
- Volunteers
- 124 people
- Sponsor
- AstraZeneca
SIRS, Sepsis
Utility of Presepsin in Distinguishing Between Sepsis and SIRS
This is an observational study to evaluate the diagnostic accuracy of presepsin levels to discriminate between sepsis and SIRS upon presentation with critical illness compatible with either sepsis or systemic inflammatory…
- Trial name
- NCT02052895
- Where
- 2 sites in United States
- Volunteers
- 226 people
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
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
Septic Shock
Efferon LPS Hemoperfusion for Treatment of Patients With Septic Shock
Sepsis is a global healthcare burden sepsis, it reaches 20-30 million cases annually (WHO data). Numerous studies have shown that extracorporeal hemoperfusion therapies that eliminate endotoxin and\or excess of cytokines improve…
- Trial name
- NCT04884854
- Testing
- Efferon LPS
- Where
- Russia
- Volunteers
- 9 people
- Sponsor
- Efferon JSC
Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.
- Trial name
- SAVE (NCT06517810)
- Testing
- QUELIMMUNE (SCD-PED)
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- SeaStar Medical