New model aims to perfect antibiotic dosing for sepsis in the ICU
NCT ID NCT03748095
First seen Jun 24, 2026 · Last updated Jun 30, 2026 · Updated 3 times
Summary
This study looked at 91 sepsis patients in intensive care to create a computer model that predicts the right dose of the antibiotic piperacillin/tazobactam. Researchers took blood samples at different times to measure drug levels. The goal was to develop a tool that helps doctors give the most effective and safe dose for each patient, reducing the risk of underdosing or side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- piperacillin/tazobactam (an antibiotic combination)
- What this could lead to
- If successful, this could lead to more personalized antibiotic dosing for sepsis patients in intensive care, potentially improving outcomes and reducing side effects.
- What could go wrong
- This is a small, completed modeling study, not a treatment trial. The model needs further validation before it can be used in practice, and results may not apply to all sepsis patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
91 people
The number who actually took part.
- Started
-
Mar 2019
- Finished
-
Sep 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patient hospitalized in intensive care for sepsis, involving (i) a suspected or proven infection; (ii) a systemic inflammatory response; (iii) dysfunction of at least one organ, according to the international consensus "sepsis-3"
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Major patient (age ≥18 years) male or female. * Patient hospitalized in intensive care for sepsis, involving (i) a suspected or proven infection; (ii) a systemic inflammatory response; (iii) dysfunction of at least one organ, according to the international consensus "sepsis-3". * Patient with an arterial catheter that can be used for blood sampling by the time the first dose of piperacillin / tazobactam is administered. * Patient for whom treatment with piperacillin / tazobactam, alone or in combination with another antibiotic, is prescribed according to the following modalities (drug SPC): scheduled antibiotic treatment for at least 48 hours in IV infusion of 4 g of piperacillin and 0.5 g tazobactam over 3 hours, every 6 hours or every 8 hours. * Patient affiliated to a social security scheme. * Patient informed and given his non-opposition. If the patient is unable to do so (emergency situations) the non-opposition will be obtained from the patient's representative. Exclusion Criteria: * Treatment with piperacillin and / or tazobactam within 7 days prior to evaluation. * Patient with a history of allergy to penicillins or β-lactams. * Kidney function of Kdigo score = 3 (3 times baseline plasma creatinine or plasma creatinine ≥ 354μmol / L or extra-renal clearance, or diuresis \<0.3ml / kg / h for ≥ 24h or anuria for ≥ 12h) to not include patients at very high risk of extra-renal clearance within 48 hours. * Hypersensitivity to the active substances, to any other antibacterial agent of the penicillin class or to any of the excipients. * History of severe allergic reaction to any other β-lactam. * Patient being treated with extrarenal treatment. * Patient being treated with extracorporeal circulation (ECMO). * Hepatic insufficiency patient with Child C. cirrhosis. * Patient who refused to participate or refused participation by the representative. * Person deprived of liberty by an administrative or judicial decision. * Person under tutorship or curatorship. * Pregnant or nursing woman.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU de Rouen
Rouen, France, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two cheap blood ratios put to the test as sepsis death predictors
- Can a computer model speed up sepsis blood tests?