#1 Clinical Trials Search in Europe

Abdominal infection – Trials in Disease

Go back

Ongoing Clinical Trials for Abdominal Infection

There are currently 4 clinical trials investigating new treatments for abdominal infections. These studies are testing various antibiotic combinations for patients of different ages, from newborns to adults, who are dealing with serious bacterial infections that may affect the abdomen, urinary tract, lungs, or bloodstream. The trials are taking place across multiple European countries including Spain, Hungary, Greece, Belgium, Netherlands, Slovakia, Italy, Bulgaria, France, Czechia, Latvia, and Croatia.

Clinical trial locations

Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections

This trial is designed for children aged 9 months to under 18 years who have serious bacterial infections that require hospital care and intravenous antibiotics. The study focuses on treating infections such as complicated intra-abdominal infections (serious infections inside the belly), complicated urinary tract infections, hospital-acquired pneumonia, ventilator-associated pneumonia, and bloodstream infections. These infections are caused by gram-negative bacteria, which are particularly challenging to treat.

Inclusion criteria: Children must be between 9 months and less than 18 years old. Girls who have started menstruating need a negative pregnancy test. Participants must have a suspected or confirmed infection such as those mentioned above, all caused by gram-negative bacteria, and they must require hospitalization with intravenous antibiotic treatment.

Exclusion criteria: Children with other serious unrelated infections, known allergies to the study medications, current participation in another trial, medical conditions that make participation unsafe, pregnancy or breastfeeding, history of drug or alcohol abuse, or any condition affecting their ability to understand or follow study instructions cannot join.

Study focus: The trial compares aztreonam-avibactam combined with metronidazole against the best available standard therapy. Participants are randomly assigned to one of these treatment groups. Throughout the study, their health is closely monitored with regular assessments of liver and kidney functions, side effects tracking, and blood samples to measure medication levels. Clinical and microbiological outcomes are evaluated at the end of treatment, with follow-up monitoring to ensure full recovery.

Investigational drugs: Aztreonam-Avibactam is a combination antibiotic where aztreonam kills bacteria and avibactam prevents bacteria from breaking down the antibiotic. Metronidazole is an additional antibiotic that stops bacterial and parasitic growth. Together, these medications are administered intravenously to treat complicated infections, particularly in the abdomen.

Study on High-Dose Short-Course Antibiotics for Critically Ill Patients with Pneumonia, Intra-Abdominal, or Bloodstream Infections: Ceftriaxone, Linezolid, and Cefotaxime

This trial investigates whether critically ill patients with pneumonia, intra-abdominal infections, or bloodstream infections can be effectively treated with a shorter course of high-dose antibiotics compared to conventional longer treatments. The study is aimed at adults in intensive care units who are expected to remain hospitalized for at least two more days.

Inclusion criteria: Patients must be 18 years or older with suspected or confirmed community-acquired pneumonia, hospital-acquired pneumonia, ventilator-acquired pneumonia, intra-abdominal infection, or bloodstream infection. They must be receiving one of the specified antibiotics (ceftriaxone, cefotaxime, cefuroxime, piperacillin-tazobactam, or meropenem) and be admitted to the ICU. They should also have experienced organ problems in the last 24 hours, such as low blood pressure, need for vasopressors, breathing support, or reduced kidney function.

Exclusion criteria: Patients with bacterial infections or fungal infections not related to the study focus, those who are not critically ill with the specified conditions, patients outside the age range, those not in the designated clinical trial groups, and patients from vulnerable populations are excluded.

Study focus: The trial randomly assigns patients to receive either a short course of high-dose antimicrobial treatment or conventional treatment. The primary goal is to determine if the shorter treatment achieves similar survival rates over 90 days while reducing antibiotic exposure. Throughout the study, patients are closely monitored for side effects, new infections, and overall health and recovery.

Investigational drugs: Various antimicrobials including ceftriaxone, meropenem, cefotaxime, cefuroxime, and piperacillin-tazobactam are used. These medicines fight bacterial infections by targeting essential bacterial processes, helping critically ill patients recover while potentially reducing antibiotic resistance development.

Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections

This study focuses on treating serious bacterial infections in the youngest patients—newborns and infants under 9 months old. These infections include complicated urinary tract infections, complicated intra-abdominal infections, hospital-acquired pneumonia, ventilator-associated pneumonia, sepsis, and bloodstream infections caused by gram-negative bacteria.

Inclusion criteria: Infants must be hospitalized and aged from birth to less than 9 months, including those born prematurely. For Part A of the study, they must be receiving intravenous antibiotics for a suspected or confirmed bacterial infection. For Part B, they must have a suspected or confirmed gram-negative bacterial infection requiring intravenous antibiotics.

Exclusion criteria: Infants with known allergies to the study medications, recent participation in another clinical trial within 30 days, history of severe allergic reactions to similar antibiotics, current or recent drug or alcohol abuse issues in the family, other medical conditions making participation unsafe, inability to comply with study procedures, history of liver or kidney disease, abnormal liver or kidney function tests, and those whose mothers are pregnant or breastfeeding cannot participate. Infants with a history of seizures or epilepsy are also excluded.

Study focus: The trial is conducted in two parts to study how the combination of aztreonam, avibactam, and metronidazole works in very young patients. Researchers monitor medication levels in the blood, assess liver and kidney functions, track any side effects, and evaluate how well the infections respond to treatment. The study provides crucial information about dosing and safety in this vulnerable age group.

Investigational drugs: Aztreonam is an antibiotic that stops bacterial growth. Avibactam enhances aztreonam’s effectiveness by preventing bacteria from resisting treatment. Metronidazole treats infections caused by bacteria and certain parasites. All three medications are given intravenously and work together to combat serious infections in infants.

Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections

This trial addresses one of the most challenging problems in treating infections: bacteria that are resistant to many antibiotics. Specifically, it focuses on carbapenem-resistant Enterobacterales, which cause complicated urinary tract infections, acute kidney infections, hospital-acquired pneumonia, ventilator-associated pneumonia, and complicated intra-abdominal infections.

Inclusion criteria: Patients must be at least 18 years old (or the legal age of consent in their area) and weigh 140 kg or less. They must be able to stay hospitalized during treatment. Those with known carbapenem-resistant bacteria infections must have lab confirmation within 72 to 96 hours before starting study medication and either received no more than 24 hours of appropriate antibiotic treatment or showed signs that previous treatment failed after at least 48 hours. Similar criteria apply to those with suspected resistant infections.

Exclusion criteria: Patients allergic to the study medications or similar antibiotics, those with severe kidney problems requiring dialysis, significant liver disease, pregnant or breastfeeding women, current participants in other trials, individuals with drug or alcohol abuse history, those with weakened immune systems, patients with infections not targeted by the study, and those who have received certain antibiotics recently cannot join.

Study focus: The trial compares two antibiotic combinations—cefepime/nacubactam and aztreonam/nacubactam—against the best currently available therapy. Both combinations are given intravenously for up to 14 days. The study monitors treatment success across all infection types, tracks patient recovery, and assesses the safety of these new medication combinations.

Investigational drugs: Cefepime/Nacubactam combines an antibiotic (cefepime) with a substance (nacubactam) that helps it work better against resistant bacteria. Aztreonam/Nacubactam works similarly, pairing aztreonam with nacubactam. Both combinations target the bacterial cell wall and block resistance mechanisms, offering new options for treating infections that don’t respond to standard antibiotics.

Summary

These four clinical trials represent important efforts to improve treatment options for serious bacterial infections, particularly those affecting the abdomen, urinary tract, lungs, and bloodstream. A notable feature of this research is the focus on different age groups, from newborns to adults, ensuring that treatment advances benefit patients across all life stages.

Three of the four trials investigate combinations involving aztreonam paired with enhancers like avibactam or nacubactam. This focus on antibiotic combinations reflects the growing challenge of antibiotic-resistant bacteria. By combining traditional antibiotics with substances that prevent bacterial resistance mechanisms, researchers aim to restore the effectiveness of existing treatments.

Geographically, these trials are concentrated in European countries, with Spain and Greece hosting three trials each, followed by Slovakia and Hungary with two trials each. This distribution suggests strong research infrastructure and collaboration in these regions for infectious disease studies.

The trial investigating high-dose, short-course antibiotic treatment stands out by questioning whether shorter treatment durations can achieve similar outcomes while reducing antibiotic exposure. If successful, this approach could help combat antibiotic resistance while potentially reducing treatment-related side effects and healthcare costs.

All studies address infections that are particularly serious in hospitalized patients, especially those in intensive care units. By focusing on complicated infections and resistant bacteria, these trials tackle some of the most pressing challenges in modern healthcare, where infections acquired in hospitals can be difficult to treat and lead to serious complications.

Ongoing Clinical Trials on Abdominal infection

  • Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Greece Hungary Spain

More information about
Abdominal infection:

Connected medications: