Clinical trials: Systemic Infection
Hepatitis B Infection, Chronic Infection
Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission remains a concern and has been reported in approximately 8-15% of infants born to hepatitis B e antigen (HBeAg) positive mothers with high…
- Conditions
- Hepatitis B Infection, Chronic Infection, Viremia
- Trial name
- NCT01488526
- Testing
- TDF treatment
- Where
- 5 sites in China
- Volunteers
- 200 people
- Sponsor
- New Discovery LLC
Sepsis, Septicemia
A Rapid Diagnostic of Risk in Hospitalized Patients Using Machine Learning
In this study, the investigators will deploy a software-based clinical decision support tool (eCARTv5) into the electronic health record (EHR) workflow of multiple hospital wards.
- Conditions
- Sepsis, Septicemia, Respiratory Failure, Hemodynamic Instability
- Trial name
- NCT05893420
- Testing
- eCARTv5 clinical deterioration monitoring, Standard of care control
- Where
- 3 sites in United States
- Volunteers
- 30,000 people
- Sponsor
- AgileMD, Inc.
Sepsis, SIRS
Performance Evaluation of the Nanomix eLab® CRP, PCT, and LAC Assays With the Nanomix eLab System
The performance of the eLab C-Reactive Protein, Procalcitonin, and Lactate Assays will be demonstrated during a method comparison study in which venous whole blood and plasma samples are used.
- Trial name
- NCT03876535
- Testing
- Nanomix eLab® System molecular diagnostic test (non-interventional)
- Where
- United States
- Volunteers
- 184 people
- Sponsor
- Nanomix
Hospitalized Children With Suspected or Confirmed Nosocomial Pneumonia
Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia
This is a multicenter, multinational, open label single dose pharmacokinetic (PK) study enrolling at least 32 subjects. The study aims to characterize the pharmacokinetics (PK) of a single intravenous dose of CAZ AVI in pediatric…
- Trial name
- NCT04040621
- Testing
- Ceftazidime-avibactam
- Where
- 4 sites in China, Taiwan
- Volunteers
- 4 people
- Sponsor
- Pfizer
Gram-Negative Bacterial Infections
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative…
- Trial name
- NCT06086626
- Testing
- Cefiderocol, Standard of Care
- Where
- 4 sites in United States, South Africa and 1 more
- Volunteers
- 30 people
- Sponsor
- Shionogi
Severe Sepsis
AZD9773 Dose Escalation Study
This is a double-blind, placebo-controlled, multi-center, dose-escalation study to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single and multiple ascending intravenous infusions of CytoFab (AZD9773)…
- Trial name
- NCT00615017
- Testing
- AZD9773 (CytoFab)
- Where
- 26 sites in United States
- Volunteers
- 70 people
- Sponsor
- AstraZeneca
Severe Sepsis, Septic Shock
Procalcitonin Monitoring Sepsis Study
The purpose of this study is to investigate the relationship between a procalcitonin decrease over 72 hours and outcome in patients who have severe sepsis or septic shock.
- Trial name
- MOSES (NCT01523717)
- Where
- 13 sites in United States
- Volunteers
- 858 people
- Sponsor
- Brahms AG
Infectious Disease, Fever
Validation of a Proteomic Signature and Assessment of Viremia in Children With Fever Without Source
The study is an observational blinded Validation study in pediatric patients below 3 years old with a diagnosis of Fever Without Source (FWS).
- Conditions
- Infectious Disease, Fever, Viremia
- Trial name
- NCT03224026
- Where
- Switzerland
- Volunteers
- 206 people, healthy volunteers welcome
- Sponsor
- MeMed Diagnostics Ltd.
Sepsis, Septic Shock
Multicenter Symphony IL-6 Monitoring Sepsis ICU Study
The primary objective of this study is to establish an IL-6 concentration cutoff and optimal time point(s) for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the…
- Trial name
- SYMON (NCT06181604)
- Where
- 7 sites in United States
- Volunteers
- 143 people
- Sponsor
- Bluejay Diagnostics, Inc.
Sepsis, Adult Disease
Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Baylor S&W
The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in…
- Conditions
- Sepsis, Adult Disease, Emergency Department, Severe Sepsis
- Trial name
- NCT04291417
- Testing
- CBC-DIFF Monocyte Volume Width Distribution (MDW)
- Where
- United States
- Volunteers
- 1,700 people
- Sponsor
- Beckman Coulter, Inc.
Catheter-related Bloodstream Infection
Expanded Access Program for Patients at Risk for Catheter-related Infections Who Are Not Eligible for DefenCath® Clinical Trials
The EAP for DefenCath is designed to provide access to a broader population of adult and pediatric patients using catheters for various serious medical conditions.
- Trial name
- NCT06707480
- Testing
- Taurolidine and Heparin
- Sponsor
- CorMedix Therapeutics
Severe Sepsis
Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
The main purpose of this study is to measure the amount of study drug (BMS-986189) in the blood and urine and to see if BMS-986189 is safe and well-tolerated in healthy people after a single dose.
- Trial name
- NCT02739373
- Testing
- BMS-986189
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Sepsis
Changes in Exhaled 13CO2/12CO2 Breath Delta Value as an Early Indicator of Infection in ICU Patients
Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide. The ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value (BDV).
- Trial name
- NCT02327130
- Testing
- Isomark Canary™
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Isomark, LLC
Catecholamine-resistant Hypotension (CRH), Distributive Shock
A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension
This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.
- Conditions
- Catecholamine-resistant Hypotension (CRH), Distributive Shock, High Output Shock, Sepsis
- Trial name
- ATHOS-3 (NCT02338843)
- Testing
- LJPC-501
- Where
- 115 sites in United States, Australia and 8 more
- Volunteers
- 344 people
- Sponsor
- La Jolla Pharmaceutical Company
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
Covid19, Pneumonia
Anakinra in the Management of COVID-19 Infection
Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health.
- Conditions
- Covid19, Pneumonia, Cytokine Release Syndrome, Corona Virus Infection
- Trial name
- NCT04643678
- Testing
- Anakinra, Standard of Care
- Where
- Qatar
- Volunteers
- 80 people
- Sponsor
- Hamad Medical Corporation
Covid19, ARDS
Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS
ExoFlo, Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Allograft Product, Infusion Treatment is currently being studied in Protocol DB-EF-PhaseIII-0001 in patients COVID-19 associated moderate to severe acute…
- Conditions
- Covid19, ARDS, Hypoxia, Cytokine Storm
- Trial name
- NCT04657458
- Testing
- ExoFlo
- Sponsor
- Direct Biologics, LLC
Bacteremia, Soft Tissue Infections
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection…
- Conditions
- Bacteremia, Soft Tissue Infections, Skin Diseases, Infectious
- Trial name
- NCT03643952
- Testing
- Daptomycin for Injection
- Where
- 16 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Merck Sharp & Dohme LLC
Candidiasis
Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia
The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or…
- Trial name
- NCT00106288
- Testing
- Micafungin, Liposomal Amphotericin B
- Where
- 37 sites in United States, Canada
- Volunteers
- 637 people
- Sponsor
- Astellas Pharma Inc
Lung Diseases, Obstructive, Sarcoidosis
Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")
The purpose of this study is to evaluate the safety, effectiveness, and side effects of the CryoSpray AblationTM System (CryoSpray AblationTM, "CSA" or "cryospray therapy") to treat benign airway disease in the lung using liquid…
- Conditions
- Lung Diseases, Obstructive, Sarcoidosis, Wegener's Granulomatosis, Rhinoscleroma
- Trial name
- ICEtheBAD (NCT00747461)
- Testing
- CryoSpray Ablation
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- CSA Medical, Inc.