Beta-Lactam Antibiotics InitiaL ExpoSure OptimisEd in CriticallY Ill Patients with SEpsis

NCT06766461 | Recruiting Phase 4 DMC

• 4 other identifiers: 2024-512950-13101400223100462024-512950-13-00U1111-1308-9223
• Study Type: interventional
• Target: 980
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate if an initial short double dose of beta-lactam antibiotics will reduce mortality in critically ill patients with sepsis.

Conditions

Sepsis - to Reduce Mortality in the Intensive Care Unit; Sepsis; Septic Shock

Keywords

sepsis; intensive care; critically ill; antibiotic; septic shock

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  From enrollment to 28 days

Secondary Outcomes (14)

• 90-day mortality

  From enrollment to 90 days

• 365-day mortality

  From enrollment to the 365 days

• ICU lengt of stay

  From enrollment to the end of the study period at 12 months

• Hospital lengt of stay

  From enrollment to the end of the study period at 12 months

• Time to shock reversal

  From enrollment to the end of the study period at 12 months

Study Arms (2)

Control

NO INTERVENTION

This arm will receive standard of care according to local protocol.

Intervention

EXPERIMENTAL

This arm will be treated with double dosages of beta-lactam antibiotics the first 48 hours after inclusion.

Drug: Double dosing of beta-lactam antibiotic

Interventions

Double dosing of beta-lactam antibiotic DRUG

This arm will receive double dosing of beta-lactam antibiotics for the first 48 hours after inclusion.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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".

You may not qualify if:

• 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 receiving extracorporeal membrane oxygenation (ECMO)
• Patient is already treated with a double dose of antibiotics based on suspected infection

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Maasstad Hospital: collaborator
• Albert Schweitzer Hospital: collaborator

Study Sites (1)

Maasstad Ziekenhuis

Rotterdam, Netherlands

RECRUITING

Related Publications (1)

• Horstink MMB, Geel DR, Uil CAD, Deetman PE, Endeman H, Abdulla A, Bosch TM, Rietdijk WJR, Thielen FW, Haringman JJ, van Vliet P, Rijpstra TA, Bethlehem C, Beishuizen A, Muller AE, Koch BCP; BULLSEYE investigators. Standard versus double dosing of beta-lactam antibiotics in critically ill patients with sepsis: The BULLSEYE study protocol for a multicenter randomized controlled trial. BMC Infect Dis. 2025 Mar 21;25(1):392. doi: 10.1186/s12879-025-10747-3.

  PMID: 40119275 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Central Study Contacts

Birgit C.P. Koch, PharmD

CONTACT

0031107033202; b.koch@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: January 9, 2025
• Study Start: January 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

NL (1)