Dose individualization of Antibiotics in ICU patients: to TDM or not to TDM and the effects on outcome (DOLPHIN-trial)

Completed

Conditions: critically ill patients
Infection
10019815

Registration Number: NL-OMON55835

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 486

Inclusion Criteria

All patients admitted to the adult general ICU wards and given standard of care
intravenous therapy of the target antibiotic are screened for participating in
trial.

Patients will be admitted to the cohorts based upon the following three cohorts:
1. Main cohort (COVID-19 Negative, No continuous infusion)
2. COVID-19 cohort (including continuous infusion)
3. Continuous infusion cohort (COVID-19 Negative)

Antibiotic initiation based on clinical suspicion of infection and/or cultured
pathogens susceptible to the target drugs, initial dosage prescription, and
duration of therapy are at the discretion of the attending physician. , In
order to be eligible to participate in this study, a subject must also meet all
of the following criteria:
* *18 years of age
* Receiving intravenous antibiotic therapy of the target drugs (including
continuous infusion)
* Treatment should be aimed for at least 2 days.
* Written informed consent has been obtained from the patient or their legally
authorized representative.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
* Pregnancy
* Patient already enrolled in this trial
* Antibiotic cessation before sampling
* Medium care and burn wound patients admitted to the ICU
* Patients receiving target antibiotics only as prophylaxis within the context
of Selective Digestive tract Decontamination (SDD)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter is the length of ICU stay (LOS).<br /><br><br /><br>The cohort COVID-19 patients are analysed as a separate subpopulation.<br /><br>Furthermore, to rule out any additional effects of continuous infusion on the<br /><br>endpoints, we will also consider this population as a separate cohort. This<br /><br>applies to all endpoints, and for primary endpoint the difference in achieving<br /><br>the pharmacodynamics targets (delta target attainment) is determined instead of<br /><br>the LOS in the both the COVID-19 and continuous infusion cohorts. The LOS is<br /><br>determined in both cohorts, but is reported as a secondary outcome measure.<br /><br><br /><br>The target for continuous infusion is increased from 100% T> MICECOFF to 100%<br /><br>T> 4xMICECOFF, with the dose reduction threshold for intermittent and<br /><br>continuous infusion being equal (10xMICECOFF).</p><br>

Secondary Outcome Measures