NCT07167524: EPIC

Evaluation of the Dialytic Clearance of the Combination of Peracillin and Tazobactam

Not yet recruiting Last updated 11 September 2025

What this trial tests

trial testing Dosage concentration of piperacillin and tazobactam in Sepsis in 24 participants. Not yet recruiting.

Timeline

1 October 2025

Primary endpoint
1 October 2027

1 April 2028

Quick facts

Lead sponsor	University Hospital, Rouen
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	24
Start date	1 October 2025
Primary completion	1 October 2027
Estimated completion	1 April 2028
Sites	1 location across France

Drugs / interventions tested

• Dosage concentration of piperacillin and tazobactam — full drug profile →

Conditions studied

• Sepsis — all drugs for Sepsis →
• Severe Bacterial Infections — all drugs for Severe Bacterial Infections →

Sponsor

University Hospital, Rouen

Who can join

18 and older, any sex, with Sepsis or Severe Bacterial Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Severe bacterial infections, often responsible for sepsis and septic shock, are a major challenge in critical care: approximately 50% of patients are affected, with a mortality rate of up to 40%. Their initial management consists of antibiotic therapy with an adapted spectrum of activity and dose. One of the most widely used antibiotic therapies in intensive care is the piperacillin-tazobactam (pip-taz) combination, a beta-lactam combined with a beta-lactamase inhibitor, which is indicated probabilistically in many infections (pneumopathies, intra-abdominal infections, urinary tract infections, etc.). Mortality rates of up to 40%. Their initial management consists of antibiotic therapy with an appropriate spectrum of activity and dose. One of the most widely used antibiotic therapies in intensive care is the piperacillin-tazobactam (pip-taz) combination, a beta-lactam combined with a beta-lactamase inhibitor, which is indicated probabilistically in many infections (pneumonia, intra-abdominal infections, urinary tract infections, etc.).

Intensive care patients with septic shock exhibit specific pharmacokinetics with an increased volume of distribution, notably due to significant capillary leakage, often disrupted hepatic metabolism, possible hypoalbuminemia, the presence of renal hyperclearance in the initial phase or conversely, the onset of renal failure with altered glomerular filtration rate, sometimes leading to extrarenal clearance, changes that have consequences for the efficacy and toxicity of the administered antibiotic therapy. Sepsis itself also causes renal dysfunction, with the main pathophysiological hypotheses being an alteration of microcirculation, cellular metabolic reprogramming, and deregulation of the inflammatory response. It is therefore essential to focus on the dosages administered and the pharmacokinetics of these patients. Indeed, underdosing is associated with the emergence of resistance and a poorer prognosis in intensive care patients: increased risk of treatment failure, length of stay and mortality. Conversely, significant overdoses can be associated with a poorer renal prognosis, seizures, encephalopathy which can lead to delayed awakening, prolonged duration of mechanical ventilation and intensive care stay.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.