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Войти в исследования Fundamental & clinical pharmacology · 2026
Evaluation of the Achievement of a Pharmacodynamic Target of Piperacillin-Tazobactam for the Population With Obesity: An Open Randomized Controlled Feasibility Study (TAZO-OBESITY Trial).
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Larocque Sabrina, Fournier Juliette, Brasseur-Masse Justine, Bernard Britanny, Annane Guiva, Haraoui Louis-Patrick, Ouyahia Anis, Marsot Amélie, Crevier Benoît
Аннотация
BACKGROUND: Observational studies report that prolonged infusions of piperacillin-tazobactam may enable the achievement of an optimal clinically targeted free drug concentration above the minimum inhibitory concentration (fT > MIC).
OBJECTIVES: This study aimed to assess the feasibility of a randomized controlled trial (RCT) comparing standard to prolonged infusions of piperacillin-tazobactam in the obese population.
METHODS: In this open-label RCT, patients with a body mass index (BMI) of 30 kg/m2 or higher who initiated piperacillin-tazobactam were recruited and randomly assigned to receive either standard or prolonged infusions of the antibiotic. Feasibility and safety outcomes were assessed. A blood sample was collected 24 h after the intervention to measure total piperacillin concentrations, with an exploratory aim of determining the proportion of patients who achieved 100% fT > MIC.
RESULTS: A total of 45 patients were recruited at a rate of 7.2 patients per month with a consent rate of 42.1%, achieving these feasibility objectives. Adherence to blood sampling was 77.8%, below the 80% objective. On an exploratory basis, the proportion of patients who achieved 100% fT > MIC 24 h postintervention was 64.3% in the prolonged-infusion group and 55.6% in the standard-infusion group (p = 0.725). There was no significant difference in the safety outcomes (p = 0.756).
CONCLUSION: This first RCT evaluating prolonged infusions of piperacillin-tazobactam in the obese population demonstrated the feasibility of the protocol. Although not statistically significant, the results suggest a favorable trend for fT > MIC attainment and no safety signal for prolonged infusions and support the conduct of a larger scale RCT.
TRIAL REGISTRATION: Clinical trial registration: NCT #06690905.
OBJECTIVES: This study aimed to assess the feasibility of a randomized controlled trial (RCT) comparing standard to prolonged infusions of piperacillin-tazobactam in the obese population.
METHODS: In this open-label RCT, patients with a body mass index (BMI) of 30 kg/m2 or higher who initiated piperacillin-tazobactam were recruited and randomly assigned to receive either standard or prolonged infusions of the antibiotic. Feasibility and safety outcomes were assessed. A blood sample was collected 24 h after the intervention to measure total piperacillin concentrations, with an exploratory aim of determining the proportion of patients who achieved 100% fT > MIC.
RESULTS: A total of 45 patients were recruited at a rate of 7.2 patients per month with a consent rate of 42.1%, achieving these feasibility objectives. Adherence to blood sampling was 77.8%, below the 80% objective. On an exploratory basis, the proportion of patients who achieved 100% fT > MIC 24 h postintervention was 64.3% in the prolonged-infusion group and 55.6% in the standard-infusion group (p = 0.725). There was no significant difference in the safety outcomes (p = 0.756).
CONCLUSION: This first RCT evaluating prolonged infusions of piperacillin-tazobactam in the obese population demonstrated the feasibility of the protocol. Although not statistically significant, the results suggest a favorable trend for fT > MIC attainment and no safety signal for prolonged infusions and support the conduct of a larger scale RCT.
TRIAL REGISTRATION: Clinical trial registration: NCT #06690905.