Study on Piperacillin-Tazobactam and Temocillin for Treating Severe Infections in ICU Patients with ESBL-Producing Gram-Negative Bacteria
This trial is investigating alternative treatment approaches for severe infections caused by bacteria that have developed resistance to many commonly used antibiotics. Specifically, the study focuses on infections caused by ESBL-producing Enterobacteriaceae, a type of bacteria that produces an enzyme making them resistant to many standard antibiotics. These infections are particularly concerning in patients admitted to intensive care units, where the severity of illness and weakened immune systems can lead to rapid disease progression.
Who can participate: The trial is open to adults aged 18 years or older who are hospitalized in the ICU with a severe infection. The infection must be caused by ESBL-producing bacteria that are treatable with the study medications (meropenem, piperacillin/tazobactam, or temocillin). Participants may have sepsis or septic shock, which are serious conditions where the body's response to infection can damage its own tissues and cause dangerously low blood pressure. Patients must provide informed consent, either directly or through a legal representative. In emergency situations where consent cannot be obtained immediately, the study may proceed with consent sought as soon as possible. Participants must also be affiliated with social security.
Who cannot participate: The trial excludes patients who are not in the ICU, those who do not have a severe infection caused by ESBL-producing bacteria, patients outside the specified age range, and those not meeting the clinical trial group requirements. Certain vulnerable populations are also excluded from participation.
Treatment approach: Participants will be randomly assigned to receive one of three antibiotic treatments administered directly into the bloodstream through an infusion. The treatments being compared are meropenem (the standard carbapenem antibiotic), piperacillin/tazobactam, and temocillin. The latter two are being tested as alternatives that could potentially reduce the use of carbapenems, which is important for managing antibiotic resistance. The treatment period lasts up to 21 days, with dosage and frequency adjusted according to the patient's condition and assigned treatment.
Study goals: The main objective is to determine whether piperacillin/tazobactam and temocillin are as effective as meropenem in treating these severe infections. Researchers will primarily focus on comparing survival rates to ensure that the alternative treatments do not lead to higher mortality. Additional observations include the length of stay in the ICU and hospital, any side effects from the medications, overall recovery process, and potential for infection relapse or complications. Participants will be followed for 30 days after treatment to assess immediate outcomes, with an additional evaluation at 90 days to understand long-term results.
Investigational drugs: The trial is testing piperacillin-tazobactam and temocillin, both administered intravenously. Piperacillin-tazobactam is a combination antibiotic consisting of a penicillin derivative and a beta-lactamase inhibitor that works by stopping bacterial growth through inhibiting cell wall synthesis. Temocillin is a beta-lactam antibiotic, also a penicillin derivative, that destroys bacteria by the same mechanism. Both medications are being evaluated as carbapenem-sparing options, meaning they could help preserve the effectiveness of carbapenems by providing equally effective alternatives for this type of infection.
France