Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
NCT ID:
NCT06766461
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years of age
* Receiving intravenous antibiotic therapy of the target drugs (including continuous infusion of beta-lactam antibiotics)
* Primary infection
* Admitted to the ICU
* Meeting the Sepsis-3 criteria for septic shock: sepsis in addition to shock requiring the start of vasopressors to maintain a mean arterial pressure 65 mmHg or greater, and a serum lac tate level greater than 2.0 mmol/L following "adequate fluid resuscitation".
Exclusion Criteria:
* Patient or legal representative not available to give informed consent within 72 hours after admittance
* Pregnancy
* Admittance for burn wounds
* Patients receiving target antibiotics only as prophylaxis within the context of Selective Diges tive tract Decontamination (SDD)
* Enrolment in another interventional trial
* Patient received the study antibiotic for more than 24 hours before inclusion
* Patient receiving extracorporeal membrane oxygenation (ECMO)
* Patient is already treated with a double dose of antibiotics based on suspected infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06766461
Study Brief:
Protocol Section:
NCT06766461