Clinical trials: Sepsis Bacterial
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
Gram-Negative Bacterial Infections, Sepsis
The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial
Aim of the study is to verify whether Polymyxin-B hemoperfusion protects from renal dysfunction in patients with severe sepsis from gram negative infection.
- Trial name
- NCT00490477
- Testing
- Polymyxin -B fiber hemoperfusion system
- Where
- Italy
- Volunteers
- 16 people
- Sponsor
- University of Turin, Italy
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
Candidemia, Mycoses
Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).
- Conditions
- Candidemia, Mycoses, Fungal Infection, Invasive Candidiases
- Trial name
- ReSTORE (NCT03667690)
- Testing
- Rezafungin for Injection, Caspofungin, Fluconazole
- Where
- 132 sites in United States, Argentina and 16 more
- Volunteers
- 199 people
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Mycoses, Candidiasis, Invasive
Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.
- Conditions
- Mycoses, Candidiasis, Invasive, Candidemia
- Trial name
- NCT02244606
- Testing
- SCY-078, Fluconazole, Micafungin
- Where
- 30 sites in United States, El Salvador and 3 more
- Volunteers
- 27 people
- Sponsor
- Scynexis, Inc.
Endocarditis, Bacterial, Infective Endocarditis
Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia
The overall goals of this study are to compare the safety and efficacy of daptomycin monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels of 15 to 20 μg/mL for the treatment of…
- Trial name
- HDSAB (NCT00695903)
- Testing
- daptomycin, vancomycin
- Where
- 2 sites in United States
- Volunteers
- 38 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Staphylococcus Aureus Bacteremia
Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects.
This study is a Phase I/II, double-blind, placebo-controlled trial investigating the True Human monoclonal antibody 514G3 in subjects hospitalized with Staphylococcus aureus bacteremia.
- Trial name
- NCT02357966
- Testing
- 514G3 (2 mg/kg) plus standard IV antibiotic treatment, 514G3 (10 mg/kg) plus standard IV antibiotic treatment, 514G3 (40 mg/kg) plus standard IV antibiotic treatment
- Where
- 2 sites in United States
- Volunteers
- 52 people
- Sponsor
- XBiotech, Inc.
Candidiasis
Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.
- Trial name
- MAGIC-2 (NCT00815516)
- Testing
- micafungin, amphotericin B deoxycholate
- Where
- 17 sites in United States, Brazil and 10 more
- Volunteers
- 30 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Clostridium Difficile Infection (CDI)
A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI.
- Trial name
- NCT02692651
- Testing
- Fidaxomicin, Vancomycin
- Where
- 2 sites in United States
- Volunteers
- 144 people
- Sponsor
- University of Michigan
Substance Use Disorders, Infection, Soft Tissue
Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use
Standard of care for patients with opioid use disorder and complicated infections is discharge to subacute nursing facilities on IV antibiotics until completion of treatment course.
- Conditions
- Substance Use Disorders, Infection, Soft Tissue, Bacteremia, Osteomyelitis Acute
- Trial name
- AIM-STOP (NCT05521880)
- Testing
- Oritavancin
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Maryland, Baltimore
Bloodstream Infection, Sepsis Bacterial
Effect of Direct-from-blood Bacterial Testing on Antibiotic Administration and Clinical Outcomes
Bacterial blood stream infections are common and life-threatening. Bloodstream infections have historically been identified using blood cultures, which often take 24-72 hours to result and are imperfectly sensitive.
- Conditions
- Bloodstream Infection, Sepsis Bacterial, MRSA Bacteremia, Vancomycin
- Trial name
- NCT06069206
- Testing
- T2Bacteria® Panel (direct-from-blood testing), Usual Care
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Vanderbilt University Medical Center
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
Infective Endocarditis
Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)
multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the treatment of SAIE
- Trial name
- NCT00638157
- Testing
- daptomycin, daptomycin and gentamicin
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Endocarditis, Bacteremia
Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis
This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the completion of therapy in patients with complicated bacteremia or infective endocarditis.
- Trial name
- NCT03148756
- Testing
- Dalbavancin, Standard of Care
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- AbbVie
Bacteremia
A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions
Background: Contaminated blood cultures result in unnecessary antibiotic use, increased length of stay, and additional laboratory tests, all of which increase healthcare costs.
- Trial name
- NCT01216761
- Testing
- Iodine tincture, Chlorhexidine gluconate, Povidone iodine
- Volunteers
- 3,879 people
- Sponsor
- University of Michigan
Candidiasis, Invasive, Candidemia
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.
- Conditions
- Candidiasis, Invasive, Candidemia, Mycoses
- Trial name
- NCT00413218
- Testing
- Isavuconazole, Caspofungin, Voriconazole
- Where
- 113 sites in United States, Argentina and 23 more
- Volunteers
- 450 people
- Sponsor
- Astellas Pharma Inc
Tuberculosis, HIV I Infection
Early Empiric Anti-Mycobacterium Tuberculosis Therapy for Sepsis in Sub-Saharan Africa
In sub-Saharan Africa, tuberculosis (TB) is the etiology of 25-50% of bloodstream infections (BSIs) and the leading cause of sepsis among people living with HIV.
- Conditions
- Tuberculosis, HIV I Infection, Sepsis
- Trial name
- ATLAS (NCT04618198)
- Testing
- Immediate anti-TB therapy, Sepsis-specific dose anti-TB therapy
- Where
- 2 sites in Tanzania, Uganda
- Volunteers
- 437 people
- Sponsor
- University of Virginia
Severe Sepsis
S.A.F.E.BT System Extracorporeal Treatment With DIAPACT CRRT
The purpose of this study is to determine if Selective Adsorption System for Removal of Bacterial Toxins (S.A.F.E.BT) therapy is effective in the treatment of severe sepsis.
- Trial name
- SAFEbt (NCT01312675)
- Testing
- S.A.F.E.BT
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- B. Braun Medical Inc.
Bacterial Infection, Benign Neoplasm
Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant
This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it works compared to control cleansing in preventing central line associated bloodstream infection and acquisition of multi-drug resistant…
- Conditions
- Bacterial Infection, Benign Neoplasm, Malignant Neoplasm, Methicillin-Resistant Staphylococcus Aureus Infection
- Trial name
- NCT01817075
- Testing
- Chlorhexidine Gluconate Skin Cleanser, Laboratory Biomarker Analysis, Mild Soap Skin Cleanser
- Where
- 59 sites in United States, Canada and 1 more
- Volunteers
- 177 people
- Sponsor
- Children's Oncology Group
Staphylococcal Infection
A Study of MK-3009 in Japanese Patients With Skin or Blood Stream Infections Caused by Methicillin-resistant Staphylococcus Aureus (MK-3009-002)
The study investigates the efficacy and safety of MK-3009 in participants with skin infections, septicemia and right-sided infective endocarditis (RIE) caused by methicillin-resistant Staphylococcus aureus (MRSA).
- Trial name
- NCT00770341
- Testing
- Daptomycin 4 mg/kg, Comparator: vancomycin, Daptomycin 6 mg/kg
- Volunteers
- 122 people
- Sponsor
- Merck Sharp & Dohme LLC