Using higher doses of beta-lactam antibiotics for critically ill patients with sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Maasstad Ziekenhuis
  Rotterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Birgit C.P. Koch, PharmD
• Email: b.koch@erasmusmc.nl
• Phone: 0031107033202

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.