CEFTAZIDIME for Sepsis | Gram-negative sepsis

Inclusion criteria

• {"criterion_text":"- Patient at least 18 years old\n- Patient hospitalized in critical care for an expected duration of at least 72 hours, with an infection for which initiation of ceftazidime therapy is being considered\n- Patient with arterial catheter for blood sampling\n- Patient affiliated to or entitled under a social security scheme"}

Exclusion criteria

• {"criterion_text":"- Pregnant, parturient and nursing women\n- Person deprived of liberty, hospitalized without consent\n- Adult subject to a legal protection measure (guardianship-curatorship)\n- History of severe hypersensitivity to ceftazidime, other cephalosporins or any other type of beta-lactam\n- Patients who have received ceftazidime within the last 72 hours\n- Patients undergoing renal replacement therapy or whose CKD-EPI at the start of treatment is less than 15 ml/min"}

Primary endpoints

• {"endpoint_text":"- Percentage of subjects with a ceftazidime concentration equal to or above the target concentration threshold (35 mg/L) at both 3h and 24h after the first administration and below the toxicity threshold of 100 mg/L","definition_or_measurement_approach":"Ceftazidime plasma concentration measured at 3 hours and 24 hours after first administration; target defined as ≥35 mg/L at both timepoints and <100 mg/L (toxicity threshold)."}

Secondary endpoints

• {"endpoint_text":"- Patient severity assessed using the SOFA (Sepsis related Organ Failure Assessment) score at D0 and D7. The SOFA score is a tool used in intensive care to assess the severity of organ failure in critical patients. The score assesses the function of six systems: respiratory, cardiovascular, hepatic, hemostatic, renal and neurological. Each system is scored from 0 to 4, meaning that the total SOFA score can vary from 0 to 24. There is no specific threshold for determining disease severity, as the S","definition_or_measurement_approach":"SOFA score calculated at baseline (D0) and Day 7, summing scores (0–4) across six organ systems to assess change in organ dysfunction/severity."}
• {"endpoint_text":"- Death up to D28","definition_or_measurement_approach":"All-cause mortality assessed through Day 28 after inclusion/treatment initiation."}
• {"endpoint_text":"- Occurrence of neurological adverse events defined as: seizure, myoclonus, encephalopathy or delirium, altered consciousness (Glasgow score)","definition_or_measurement_approach":"Recording and classification of neurological adverse events including seizures, myoclonus, encephalopathy, delirium, and changes in Glasgow Coma Scale."}
• {"endpoint_text":"- Occurrence of an overdose defined as a concentration greater than 100 mg/L","definition_or_measurement_approach":"Ceftazidime plasma concentration measurements; overdose defined as >100 mg/L."}
• {"endpoint_text":"- Renal function assessed using the following estimators: creatinemia cystatin CKD-EPI, creatinuria/creatininemia ratio (U×V/P) and eGFR creat-cystatin","definition_or_measurement_approach":"Assessment of renal function using serum creatinine and cystatin C-based CKD-EPI, urine creatinine/serum creatinine ratio (U×V/P), and combined creatinine–cystatin eGFR estimators."}
• {"endpoint_text":"- Time to reach PK/PD targets (in hours post treatment introduction)","definition_or_measurement_approach":"Time (hours) from treatment initiation until predefined PK/PD targets are achieved, measured via plasma concentrations and PK/PD calculations."}

France

Earliest CTIS Part Ii Submission Date

12-06-2025

Latest Decision Or Authorization Date

12-02-2026

Processing Time Days

245

Number Of Sites

8

Number Of Participants

128

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Saint Etienne

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France