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| ID | Type | Description | Link |
|---|---|---|---|
| 10140022310046 | Other Grant/Funding Number | ZonMW | |
| 2024-512950-13-00 | EU Trial (CTIS) Number | ||
| U1111-1308-9223 | Registry Identifier | WHO universal trial number (UTN) |
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| Name | Class |
|---|---|
| Maasstad Hospital | OTHER |
| Albert Schweitzer Hospital | OTHER |
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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.
Objective
To determine if using higher dosages of beta-lactam antibiotics in the initial phase of sepsis improves clinical outcome of critically ill patients.
Main trial endpoints
The main trial endpoint is all cause 28-day mortality.
Secondary trial endpoints
Secondary trial endpoints include: Hospital length of stay, ICU length of stay, microbiological eradication, time to shock reversal, clinical cure, Δ Lactate, Δ PCT, Δ SOFA, 90- day mortality, 365-day mortality, pharmacodynamic target, post study calculation of the costs in both study, groups, EQ5D questionnaire 3 and 12 months after Admission, iMTA productivity questionnaire 3 and 12 months after admission, iMTA medical consumption questionnaire 3 and 12 months after admission and the number of adverse events.
Trial design
This is an open label, randomized controlled trial.
Trial population
The trial population will consist of adult patients admitted to the intensive care department with sepsis who will be treated according to protocol with beta-lactam antibiotics.
Interventions
During the trial participants in the intervention group will receive a double dose of antibiotics for the first 48 hours in comparison to the standard dose in the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double dosing of beta-lactam antibiotic | Drug | This arm will receive double dosing of beta-lactam antibiotics for the first 48 hours after inclusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | From enrollment to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day mortality | From enrollment to 90 days | |
| 365-day mortality | From enrollment to the 365 days | |
| ICU lengt of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Birgit C.P. Koch, PharmD | Contact | 0031107033202 | b.koch@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maasstad Ziekenhuis | Recruiting | Rotterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40119275 | Derived | Horstink MMB, Geel DR, den Uil CA, 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. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| 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 use of <0.1 gamma of vasopressors for 4 consecutive hours. | From enrollment to the end of the study period at 12 months |
| Microbiological eradication | Eradication of the causative organism from the primary source up to 30 days after therapy when confirmed by at least one repeated culture. In cases where there were no repeat cultures and the patient had resolution of the infection, microbial eradication will be presumed. | From enrollment to hospital discharge |
| Clinical cure | Completion of β-lactam antibiotic by day 14 without recommencement of antibiotics within 48hrs of cessation for same infective episode (investigator assessment of clinical response) | From enrollment to 14 days |
| Plasma concentrations of the beta-lactam antibiotics | Through concentrations take once a day for 3 consectutive days after enrollment. Target attianment is defined as 100%fT>4xMIC | From enrollment to day 3 |
| Delta SOFA | SOFA at day 3 - SOFA at admission | From enrollment to day 3 |
| Delta Lactate | Lactate at day 3 - lactate upon inclusion | From enrollment to day 3 |
| Quality of life | EQ-5D-5L, a quetionnaire scoring 1 to 5 points on 5 domains. A higher score means a worse outcome. | 3 and 12 months after inclusion |
| Medical consumption | iMTA Medical Consumption questionnaire | 3 and 12 months after inclusion |
| Productivity | iMTA Productivity questionnaire | 3 and 12 months after inclusion |
| Adverse events and toxicity | From enrollment until the end of the study period at 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D020969 | Disease Attributes |