Ongoing Clinical Trials for Haematological Infections
Currently, there are 3 ongoing clinical trials investigating new treatments for haematological infections, which are infections affecting the blood and bloodstream. These studies are being conducted across several European countries and are testing different antibiotic approaches, including single-dose treatments, high-dose short-course therapies, and combination medications for young patients.
Clinical trial locations
- Belgium
- Bulgaria
- France
- Greece
- Hungary
- Italy
- Netherlands
- Slovakia
- Spain
Study Comparing Dalbavancin to Standard Antibiotics for Patients with Staphylococcus aureus Bloodstream Infections
This trial is investigating a simpler treatment approach for bloodstream infections caused by Staphylococcus aureus bacteria that are related to catheter use. The study compares a single intravenous dose of Dalbavancin to the standard 14-day antibiotic treatment.
Who can participate: Adults aged 18 or older who have a confirmed Staphylococcus aureus infection in their blood within the past 96 hours and a catheter-related bloodstream infection are eligible. The catheter must be removed before joining the study, and participants must provide informed consent.
Who cannot participate: People with complicated infections, allergies to the study medication, kidney or liver problems, those who are pregnant or breastfeeding, participants in other trials, those with a history of substance abuse, immune system disorders, or recent antibiotic treatment are excluded from this study.
Study focus: The main goal is to determine whether a single dose of Dalbavancin is as effective as the standard 14-day antibiotic treatment in curing the infection without it returning within 30 days. The study will also monitor how quickly the infection clears from the blood, hospital stay duration, and any side effects experienced by participants.
Investigational drugs: Dalbavancin is a glycopeptide antibiotic given as a single 1500 mg intravenous dose. It works by preventing bacteria from building their cell walls, which is essential for their survival. The standard antibiotic therapy arm follows national guidelines with antibiotics administered over 14 days.
Study on High-Dose Short-Course Antibiotics for Critically Ill Patients with Pneumonia, Intra-Abdominal, or Bloodstream Infections: Ceftriaxone, Linezolid, and Cefotaxime
This trial is examining whether critically ill patients in intensive care units with serious infections can be treated effectively with shorter, high-dose antibiotic courses instead of conventional longer treatments.
Who can participate: Adults aged 18 or older who are admitted to an intensive care unit with confirmed or suspected pneumonia, intra-abdominal infection, or bloodstream infection are eligible. Patients must be receiving treatment with specific antibiotics including ceftriaxone, cefotaxime, cefuroxime, piperacillin-tazobactam, or meropenem. They must be expected to stay in the ICU for at least two more days and have experienced recent organ problems such as low blood pressure, need for blood pressure support medications, breathing support requirements, or decreased kidney function.
Who cannot participate: The study excludes patients with bacterial or fungal infections who are not critically ill with the specified infection types, those outside the study age range, and patients with certain conditions that would require longer or different antibiotic treatments, such as heart valve infections, specific types of blood infections, or bone infections.
Study focus: The primary aim is to compare 90-day survival rates between patients receiving short-course, high-dose antibiotic treatment and those receiving conventional treatment. The study will also monitor for new infections, overall health recovery, and potential side effects to determine if shorter treatment can be equally effective while reducing antibiotic exposure.
Investigational drugs: The study uses several commonly prescribed antibiotics administered intravenously, including ceftriaxone, meropenem, cefotaxime, cefuroxime, and piperacillin-tazobactam. These medications work by disrupting bacterial cell processes, preventing their growth and eliminating the infection.
Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
This trial is studying a combination antibiotic treatment for serious infections in newborns and infants under 9 months old. The infections being studied include urinary tract infections, abdominal infections, pneumonia acquired in hospitals, bloodstream infections, and sepsis caused by gram-negative bacteria.
Who can participate: Hospitalized infants from birth to less than 9 months old, including those born prematurely, are eligible. In Part A of the study, infants receiving intravenous antibiotics for suspected or confirmed bacterial infections can participate. In Part B, infants must have a suspected or confirmed gram-negative bacterial infection requiring intravenous antibiotics.
Who cannot participate: Infants with known allergies to the study medications, those who participated in another trial within 30 days, history of severe allergic reactions to antibiotics, drug or alcohol abuse history in the family, certain medical conditions deemed unsafe by doctors, inability to comply with study procedures, liver or kidney disease, abnormal liver or kidney function tests, or history of seizures or epilepsy are excluded. Pregnant or breastfeeding mothers cannot participate.
Study focus: The trial aims to understand how the combination of Aztreonam and Avibactam, with or without Metronidazole, works in young infants’ bodies. Researchers will monitor medication levels in the blood, assess safety and tolerability, observe any side effects, and evaluate how well the treatment helps infants recover from serious bacterial infections.
Investigational drugs: Aztreonam is an antibiotic that stops bacterial growth by disrupting cell wall formation. Avibactam is a beta-lactamase inhibitor that helps other antibiotics work better against resistant bacteria by blocking enzymes that bacteria produce to break down antibiotics. Metronidazole is an antiprotozoal and antibacterial agent that disrupts bacterial DNA, preventing bacteria from multiplying. All three medications are administered intravenously.
Summary
The three ongoing clinical trials for haematological infections represent diverse approaches to treating bloodstream and related infections across different patient populations. Notably, the trials are concentrated in European countries, with the study on treatments for infants being conducted in the most locations across six countries including Slovakia, Italy, Hungary, Bulgaria, Greece, and Spain.
The trials reflect current concerns in infection management, including the development of simpler treatment regimens that may reduce hospital stays and improve patient convenience, as seen in the Dalbavancin study. There is also emphasis on optimizing antibiotic use in critically ill patients through shorter, high-dose treatments to minimize antibiotic exposure while maintaining effectiveness. Additionally, the research addresses the important need for effective treatments for vulnerable populations, specifically very young infants with serious infections caused by resistant bacteria.
These studies investigate various antibiotic classes and combinations, from single-dose long-acting antibiotics like Dalbavancin to combination therapies using beta-lactamase inhibitors to combat antibiotic resistance in gram-negative bacteria. The trials aim to provide evidence that could reshape treatment approaches for bloodstream infections across different patient groups.