Using higher doses of beta-lactam antibiotics for critically ill patients with sepsis
Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis
This study is testing if giving critically ill patients with sepsis a higher dose of beta-lactam antibiotics can help them recover better and live longer compared to the standard dose.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 980 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT06766461 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if administering a double dose of beta-lactam antibiotics in the initial phase of treatment can improve outcomes for critically ill patients suffering from sepsis. It is an open-label, randomized controlled trial that will compare the effects of this higher dosage against the standard dose in a population of adult ICU patients meeting specific sepsis criteria. The primary endpoint is all-cause mortality within 28 days, while secondary endpoints include hospital and ICU length of stay, microbiological eradication, and various clinical measures over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted to the ICU with sepsis and require vasopressors to maintain blood pressure.
Not a fit: Patients who are pregnant, have burn wounds, or are already receiving double doses of antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality rates in critically ill patients with sepsis.
How similar studies have performed: Other studies have explored antibiotic dosing strategies in sepsis, but this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rotterdam
- Maasstad Ziekenhuis — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Birgit C.P. Koch, PharmD
- Email: b.koch@erasmusmc.nl
- Phone: 0031107033202
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.