Ongoing Clinical Trials for Sepsis
This article provides information about 21 ongoing clinical trials studying various treatments for sepsis, a serious condition that occurs when the body’s response to infection causes injury to its own tissues and organs. These trials are investigating different medications, dosing strategies, and treatment approaches across multiple countries including France, Spain, Germany, Greece, Italy, and others.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- France
- Study of hydrocortisone and fludrocortisone combination versus placebo in adults with sepsis in intensive care unit to determine corticosteroid response
- Study of REGN7544 for Treating Adults with Low Blood Pressure Caused by Sepsis
- Study on the Effects of Amikacin Sulfate and Protective Isolation in Critically Ill Neutropenic Patients with Sepsis
- Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury
- Evaluation of Optimized Ceftazidime Dosing Regimen Versus Standard Treatment for Critical Care Patients with Sepsis
- Study Comparing Different Antibiotic Treatments for ICU Patients with Hospital-Acquired Sepsis: Focus on Cefepime and Drug Combination
- Study on Dobutamine and Glucose for Patients with Septic Cardiomyopathy and Low Blood Flow
- Germany
- Study on the Effects of Immunoglobulin A, G, and M in Patients with Peritonitis and Sepsis After Infection Control
- Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury
- Study on Epirubicin and Sodium Chloride for Patients with Sepsis or Septic Shock in Intensive Care Units
- Greece
- Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections
- Study on Avibactam and Drug Combination for Treating Severe Infections in Patients
- Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
- Study on Early Clarithromycin Treatment to Prevent Sepsis in Patients with Community-Acquired Pneumonia
- Study on Emapalumab for Patients with Sepsis Linked to Interferon-Gamma
- Hungary
- Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections
- Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury
- Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
- Italy
- Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury
- Study of vitamin D3 (cholecalciferol) as additional treatment for elderly patients with pneumonia or sepsis due to infection
- Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
- Netherlands
- Norway
- Slovakia
- Spain
- Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections
- Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury
- Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
- Study on Noradrenaline and Terlipressin for Treating Septic Shock in Patients
- Study on Personalized Linezolid Dosing for Patients with Sepsis
Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections
This trial is investigating a combination of antibiotics for children aged 9 months to less than 18 years who have serious bacterial infections. The study focuses on infections caused by gram-negative bacteria, which are a type of bacteria that can cause severe illness.
Main inclusion criteria: Participants must be between 9 months and 18 years old. They must have a suspected or confirmed serious infection, such as complicated intra-abdominal infection, complicated urinary tract infection, hospital-acquired pneumonia, ventilator-associated pneumonia, or bloodstream infection. These infections must be caused by gram-negative bacteria and require treatment with intravenous antibiotics. Female participants who have started menstruating must have a negative pregnancy test.
Main exclusion criteria: Children cannot participate if they have other serious infections unrelated to the study, known allergies to the study medications, are currently in another clinical trial, have medical conditions that would make participation unsafe, are pregnant or breastfeeding, have a history of substance abuse, or cannot understand study instructions.
Trial focus: The study aims to evaluate whether the combination of aztreonam-avibactam and metronidazole is effective in treating these serious infections in children. Throughout the treatment, doctors will monitor liver and kidney function, measure drug levels in the blood, and assess how well the infections respond to treatment.
Investigational drugs: Aztreonam-avibactam is a combination antibiotic where aztreonam kills bacteria and avibactam helps prevent bacteria from breaking down the antibiotic. Metronidazole is another antibiotic that works alongside the combination to treat complicated abdominal infections.
Study of hydrocortisone and fludrocortisone combination versus placebo in adults with sepsis in intensive care unit to determine corticosteroid response
This study examines whether a combination of two steroid medications can help patients with severe infections in the intensive care unit. The research aims to identify which patients would benefit most from this treatment.
Main inclusion criteria: Participants must be at least 18 years old and admitted to intensive care with suspected or proven infection. They must have one of the following: community-acquired pneumonia related sepsis, need for blood pressure medications, septic shock requiring vasopressors and having high lactate levels, or acute respiratory distress syndrome. Patients must have been tested for specific biological markers and have health insurance coverage.
Main exclusion criteria: People cannot participate if they are under 18 or over 89 years old, pregnant or breastfeeding, have known allergies to the study medications, already receive systemic corticosteroids, have severe immunosuppression, had recent major surgery, have active bleeding or high bleeding risk, or have severe liver disease.
Trial focus: The study will track patient survival and recovery from organ problems over 90 days. Researchers will monitor whether patients still need breathing machines, blood pressure medications, or kidney support. Patients receive either hydrocortisone through a vein and fludrocortisone tablets, or placebo versions of these medications.
Investigational drugs: Hydrocortisone is a steroid that reduces inflammation and helps manage the body’s inflammatory response in severe infections. Fludrocortisone helps regulate salt and water balance and supports proper blood pressure maintenance in critically ill patients.
Study of REGN7544 for Treating Adults with Low Blood Pressure Caused by Sepsis
This trial investigates a new medication called REGN7544 for patients experiencing dangerously low blood pressure caused by severe infection. The study evaluates whether this treatment can reduce the need for blood pressure support medications.
Main inclusion criteria: Patients must have a proven or suspected infection requiring antibiotic treatment. They must have low blood pressure caused by severe infection that did not improve with intravenous fluids. Patients should be receiving 1 or 2 vasopressor medications and maintain a mean arterial pressure of at least 65 mm Hg for at least 2 consecutive hours before enrollment.
Main exclusion criteria: People cannot participate if they do not have low blood pressure caused by infection, are outside the specified age range, or belong to vulnerable populations requiring special protection.
Trial focus: The study aims to assess how well REGN7544 can reduce the need for vasopressor medications that help raise blood pressure. Participants receive either REGN7544 or placebo through intravenous infusion. Researchers monitor blood pressure levels, vasopressor requirements, and overall health indicators throughout the study.
Investigational drugs: REGN7544 is a monoclonal antibody designed to block a protein called NPR1. By blocking this protein, the medication may help stabilize blood pressure and reduce the need for other blood pressure-raising medications.
Study on Avibactam and Drug Combination for Treating Severe Infections in Patients
This trial explores a new treatment strategy for severe infections using advanced diagnostic methods combined with antibiotic treatment. The study compares this new approach with standard care.
Main inclusion criteria: Participants must be 18 years or older and have one of the following infections: community-acquired pneumonia, hospital-acquired pneumonia, ventilator-associated pneumonia, acute pyelonephritis, or primary bacteremia. They must have a positive blood culture and meet specific criteria for organ function using the SOFA score. Written informed consent is required, though legal representatives can provide consent if needed.
Main exclusion criteria: Patients with severe infections cannot participate in this trial.
Trial focus: The study aims to reduce the number of days patients receive broad-spectrum antibiotics. It uses procalcitonin guidance and molecular-guided diagnosis to help doctors make better treatment decisions. The trial monitors time to antibiotic changes, time to achieve sterile blood cultures, hospital stay length, and mortality rates.
Investigational drugs: The trial uses procalcitonin-guided therapy, which measures blood levels of procalcitonin to guide antibiotic use decisions. It also employs molecular-guided diagnosis, which uses advanced technology to identify specific bacteria causing infections, allowing doctors to choose the most effective targeted antibiotics.
Study on Optimizing Initial Dosing of Flucloxacillin and Drug Combination for Critically Ill Patients with Sepsis in the ICU
This study examines the best way to give beta-lactam antibiotics to critically ill patients in intensive care. The research compares a new dosing strategy with standard treatment approaches.
Main inclusion criteria: Participants must be 18 years or older and admitted to intensive care with a primary infection. They must meet criteria for septic shock, which includes needing vasopressor medications to maintain blood pressure at 65 mm Hg or higher and having serum lactate levels above 2.0 mmol/L after receiving adequate fluids. Patients must be receiving intravenous beta-lactam antibiotic therapy.
Main exclusion criteria: People cannot participate if they do not have sepsis, are not in intensive care, are younger than 18 or older than 65 years, or belong to vulnerable populations.
Trial focus: The study evaluates whether a new dosing strategy can improve outcomes for patients by maintaining optimal antibiotic levels in the bloodstream. Researchers monitor blood antibiotic levels at 24, 48, and 72 hours, track infection parameters like C-reactive protein and white blood cell count, and assess organ function over time.
Investigational drugs: The trial uses various beta-lactam antibiotics including flucloxacillin, cefuroxime, ceftriaxone, amoxicillin with clavulanic acid, cefotaxime, piperacillin with tazobactam, amoxicillin, ceftazidime, and meropenem. These antibiotics work by interfering with bacterial cell walls, ultimately killing the bacteria.
Study on Teicoplanin Dosing for Patients with Sepsis: Comparing TDM-Optimized Dosing to Standard Care
This trial investigates two different methods of dosing teicoplanin antibiotic in patients with severe infections. The study compares dosing guided by therapeutic drug monitoring with standard dosing practices.
Main inclusion criteria: Patients must be admitted to intensive care, hematology, medical gastroenterology, or orthopedics departments and be at least 18 years old. They must be receiving teicoplanin as part of standard care, and either the patient or representative must be willing to sign the informed consent form.
Main exclusion criteria: People cannot participate if they have known allergies to the study medication, are pregnant or breastfeeding, have severe liver or kidney disease, are currently in another clinical trial, had major surgery within the last 30 days, have a history of substance abuse, have mental health conditions affecting study participation, or cannot provide informed consent.
Trial focus: The study aims to determine which dosing method more effectively achieves desired drug levels in the body by day 5 of treatment. Researchers monitor how quickly target drug concentrations are reached, the number of days spent in hospital, treatment failure rates, and any kidney issues during treatment.
Investigational drugs: Teicoplanin is an antibiotic used to treat serious bacterial infections. The trial compares standard fixed-dose administration with dosing adjusted based on regular blood tests that measure drug levels.
Study on the Effects of Amikacin Sulfate and Protective Isolation in Critically Ill Neutropenic Patients with Sepsis
This trial examines whether adding amikacin antibiotic to standard treatment can improve outcomes for critically ill patients with weakened immune systems. The study also evaluates whether protective isolation practices affect recovery.
Main inclusion criteria: Participants must be 18 years or older and admitted to participating intensive care units with sepsis or septic shock. They must have an underlying tumor, have undergone stem cell transplantation, or have blood-related cancer. Patients must have neutropenia, defined as having less than 500 neutrophils per cubic millimeter of blood or less than 1000 white blood cells per cubic millimeter related to cancer or its treatment.
Main exclusion criteria: People cannot participate if they are under 18 years old, not admitted to intensive care, unable to give consent, pregnant or breastfeeding, have known allergies to aminoglycosides, are already in another clinical trial, or have conditions making participation unsafe.
Trial focus: The study evaluates whether adding aminoglycoside antibiotics to initial treatment can reduce mortality rates in patients with weakened immune systems. It also assesses whether avoiding routine protective isolation is as safe and effective as using it. Researchers monitor survival rates, kidney function, and hearing throughout the trial.
Investigational drugs: Aminoglycosides are antibiotics that stop bacteria from making proteins essential for growth. The trial tests whether this combination therapy improves outcomes. The study also examines protective isolation strategies to prevent infections in patients with weakened immune systems.
Study on the Effects of Immunoglobulin A, G, and M in Patients with Peritonitis and Sepsis After Infection Control
This trial investigates whether Pentaglobin, a solution containing immunoglobulins, can help improve organ function in patients with abdominal infections and severe systemic infection after procedures to control the infection source.
Main inclusion criteria: Patients must have secondary or quaternary peritonitis with infection control procedures performed within 6 hours of decision. They must have sepsis or septic shock with a SOFA score of 8 or higher and IL-6 concentration of 1000 pg/ml or more. Antibiotic treatment must start within 12 hours of intensive care admission, and informed consent must be provided.
Main exclusion criteria: Patients with secondary or quaternary peritonitis or sepsis cannot participate in this trial.
Trial focus: The study monitors changes in multiple organ function, including lungs, heart, kidneys, liver, and blood, over seven days after infection source control. Researchers evaluate mortality rates at 28 and 90 days and track changes in organ failure severity by day 5 of treatment.
Investigational drugs: Pentaglobin is an immunoglobulin preparation containing antibodies that help the immune system fight infections. It is administered intravenously to support organ function in patients with severe abdominal infections.
Study on the Safety and Effectiveness of TIN816 for Patients with Sepsis-Related Acute Kidney Injury
This trial explores a new treatment called TIN816 for patients whose kidneys suddenly stop working properly due to severe infection. The study examines different doses to determine the most effective treatment approach.
Main inclusion criteria: Participants must be between 18 and 85 years old and admitted to intensive care or high dependency units. They must have a diagnosis of sepsis with acute kidney injury at Stage 1 or higher, shown by an increase in creatinine of at least 0.3 mg/dL within 48 hours. The sepsis diagnosis must be based on suspected or confirmed infection with a sudden increase in SOFA score by 2 or more points.
Main exclusion criteria: People cannot participate if they do not have acute kidney injury associated with severe infection, are outside the specified age range, do not meet specific clinical trial group criteria, or are not male or female.
Trial focus: The study assesses how different doses of TIN816 affect kidney function by measuring creatinine clearance from Day 1 to Day 8. Researchers also monitor for major adverse kidney events, changes in kidney function, and any side effects up to Day 90.
Investigational drugs: TIN816 is an investigational medication being studied for its potential to improve kidney function in patients with acute kidney injury caused by severe infection. The trial evaluates its ability to enhance creatinine clearance, which measures how well kidneys filter waste from blood.
Comparison of Gentamicin with Narrow-Spectrum Antibiotics versus Broad-Spectrum Antibiotics in Adult Patients with Early Sepsis
This study compares two antibiotic treatment approaches for patients with suspected severe infection that started outside the hospital. It evaluates whether combining narrow-spectrum antibiotics with gentamicin is as effective as using broad-spectrum antibiotics alone.
Main inclusion criteria: Participants must be 18 years or older, currently admitted to hospital with suspected community-acquired sepsis requiring antibiotic treatment, and have a NEWS2 score of 5 or higher. They must be able to understand and sign informed consent forms. Both male and female patients can participate.
Main exclusion criteria: People cannot participate if they are under 18 or over 65 years old, have known allergies to study antibiotics, are pregnant or breastfeeding, have severe kidney or hearing problems, have hospital-acquired infections, are already receiving antibiotic treatment, have severe liver disease, are in other clinical trials, cannot provide informed consent, or have life-threatening conditions requiring immediate intensive care.
Trial focus: The study monitors kidney function, overall health status, hospital stay length, and need for intensive care, breathing support, or blood pressure medications during the first 30 days. Researchers track hospital readmissions and health status after discharge.
Investigational drugs: The trial compares combinations of narrow-spectrum antibiotics including penicillin, ampicillin, or cloxacillin with gentamicin versus broad-spectrum antibiotics including cefotaxime or piperacillin-tazobactam. All medications are given intravenously.
Evaluation of Optimized Ceftazidime Dosing Regimen Versus Standard Treatment for Critical Care Patients with Sepsis
This trial evaluates whether an optimized way of giving ceftazidime antibiotic can more quickly achieve and maintain effective medication levels in critically ill patients compared to standard dosing methods.
Main inclusion criteria: Participants must be at least 18 years old, hospitalized in critical care for at least 72 hours with infection requiring ceftazidime treatment, and have an arterial catheter for blood sampling. They must be affiliated with or entitled to social security benefits.
Main exclusion criteria: People cannot participate if they are pregnant or breastfeeding, have known allergies to ceftazidime or similar antibiotics, have severe kidney failure requiring dialysis, have severe liver disease, are already in another clinical trial, have conditions preventing safe participation, or cannot provide informed consent without a legal representative.
Trial focus: The study monitors whether optimized ceftazidime dosing maintains blood concentrations above 35 mg/L at both 3 hours and 24 hours after the first dose while staying below the toxicity threshold of 100 mg/L. Researchers also track kidney function and neurological status for adverse events.
Investigational drugs: Ceftazidime is a broad-spectrum antibiotic used to treat various bacterial infections. The study compares an optimized dosing regimen against standard dosing to find the best administration method for critically ill patients.
Summary
The 21 ongoing clinical trials for sepsis demonstrate significant international research efforts, with notable concentration in Western European countries. France leads with 7 trials, followed by Spain with 5 trials, and Greece with 5 trials. Several trials are conducted across multiple countries, particularly the study on TIN816 for sepsis-related acute kidney injury, which spans 8 countries.
The trials focus on diverse therapeutic approaches, including antibiotic optimization, corticosteroid therapy, immunoglobulin treatment, and novel medications targeting specific sepsis mechanisms. Several studies emphasize personalized medicine approaches, such as therapeutic drug monitoring for antibiotics and biomarker-guided treatment strategies. A significant number of trials investigate antibiotic dosing strategies, reflecting ongoing efforts to optimize antimicrobial therapy in critically ill patients.
Pediatric populations are specifically addressed in two trials examining aztreonam-avibactam combinations, while elderly patients are targeted in vitamin D supplementation research. The trials encompass various sepsis presentations, including septic shock, septic cardiomyopathy, and sepsis-associated organ dysfunction, demonstrating the complexity and heterogeneity of this condition.
