External Validation of the Beta-lactam Target Non-attainment (BATMAN) Risk Score in Adult ICU Patients: a Diagnostic Multivariate Predictive Risk Model

NCT05542771 | Unknown

• 1 other identifier: NL181245.078.22
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 6

Brief Summary

Intensive care (IC) patients regularly get infections. Sometimes it is even the reason of admission to the intensive care unit. To treat these infections, we give medicines called antibiotics, such as β-lactams antibiotics. Every IC patient receives the same dose of β-lactams antibiotics, while we know this can lead to undertreatment in some IC patients. The BATMAN risk score was created to predict which IC patient is undertreated. This study aims to validate the BATMAN risk score so it can be used in clinical practice.

Conditions

Infection, Bacterial; Beta-lactam Antibiotics; Critical Care; Risk Model; Therapeutic Drug Monitoring

Keywords

External validation; Critical care; Risk model; Beta-lactam antibiotics; Therapeutic drug monitoring; infections, bacterial

Outcome Measures

Primary Outcomes (2)

• Discrimination

  The discrimination of the diagnostic risk score will be displayed in the concordance index (c-index), which is identical to the area under the receiver operating curve (AUROC), where the true positive rate (y-axis) will be plotted against the false positive rate (x-axis).

  Target attainment prediction based on the BATMAN risk score is calculated with patient data within 36 hours after of start therapy. Target attainment based on serum levels are based are measured within 36 hours after start of therapy.

• Calibration

  The calibration of the risk score will be assessed with a calibration plot, where the average predicted risk of target non-attainment is compared with the overall event rate of target non-attainment.

  Target attainment prediction based on the BATMAN risk score is calculated with patient data within 36 hours after of start therapy. Target attainment based on serum levels are based are measured within 36 hours after start of therapy.

Other Outcomes (5)

• Negative predictive value

  Target attainment prediction based on the BATMAN risk score is calculated with patient data within 36 hours after of start therapy. Target attainment based on serum levels are based are measured within 36 hours after start of therapy.

• Positive predictive value

  Target attainment prediction based on the BATMAN risk score is calculated with patient data within 36 hours after of start therapy. Target attainment based on serum levels are based are measured within 36 hours after start of therapy.

• Sensitivity

  Target attainment prediction based on the BATMAN risk score is calculated with patient data within 36 hours after of start therapy. Target attainment based on serum levels are based are measured within 36 hours after start of therapy.

Eligibility Criteria

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

Study Population

All adult patients admitted to the adult general ICU wards and treated with the target antibiotics who meet the inclusion criteria will be included.

You may qualify if:

• Written informed consent has been obtained from the patient or their legally authorised representative
• Age ≥18 years
• Treated with one of the following beta-lactam antibiotics at the ICU with intermitted dosage
• Amoxicillin (with or without clavulanic acid)
• Cefotaxime
• Ceftazidime
• Cefuroxime
• Flucloxacillin
• Meropenem
• Piperacillin with tazobactam
• Eligible blood material within 36 hours after start of beta-lactam antibiotic to determine target attainment (100%ƒT \> MICECOFF).
• Suitable intravenous/intra-arterial access to facilitate sample collection

You may not qualify if:

• Pregnancy
• Beta-lactam antibiotic cessation before blood sample collection
• Receiving beta-lactam antibiotic only as prophylaxis within the context of Selective Digestive tract Decontamination (SDD)
• Patients with renal replacement therapy
• Patients with burn injury

Sponsors & Collaborators

• Chantal Kats: lead

Study Sites (6)

Isala Hospital

Zwolle, Gelderland, 8025 AB, Netherlands

NOT YET RECRUITING

VieCuri Medical Center

Venlo, Limburg, 5912 BL, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, 3045 PM, Netherlands

NOT YET RECRUITING

Haaglanden Medisch Centrum

The Hague, South Holland, 2512VA, Netherlands

NOT YET RECRUITING

Diakonessenhuis

Utrecht, 3582 KE, Netherlands

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

4 ml blood

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Alan Adulla, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Kats, MSc

CONTACT

+31634424848; c.kats@haaglandenmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc Chantal Kats, coordinating researcher (Sponsor is Erasmus Medical Center)

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 15, 2022
• Study Start: April 24, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (6)