Prediction of inadequate empirical antiinfective therapy in critically ill patients with sepsis: a machine learning model with external validation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037998

Enrollment

637

Registered

2025-09-25

Start date

2025-09-25

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41

Interventions

Group 1: Inadequate empirical antibiotic therapy within the first 24 hours in sepsis: In cases with a positive microbial pathogen identification and availability of an antibiogram, the appropriateness

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Sepsis (according to the Sepsis-3 definition) Admission to intensive care unit

Exclusion criteria

Exclusion criteria: Cases lacking essential data to determine the primary outcome, specifically data on the antibiotic regimen, or identified causative microbial pathogen.

Design outcomes

Primary

Measure	Time frame
The primary objective of this exploratory study is to determine the frequency of inadequate empirical antibiotic therapies in intensive care patients with sepsis. An inadequate antibiotic regimen is defined as a therapy that is either ineffective against the identified pathogens according to susceptibility testing or, in the absence of resistance testing, is expected to be ineffective due to known intrinsic biological resistance.	—

Measure

Time frame

The primary objective of this exploratory study is to determine the frequency of inadequate empirical antibiotic therapies in intensive care patients with sepsis. An inadequate antibiotic regimen is defined as a therapy that is either ineffective against the identified pathogens according to susceptibility testing or, in the absence of resistance testing, is expected to be ineffective due to known intrinsic biological resistance.

—

Secondary

Measure	Time frame
A secondary objective is the identification of independent predictors of inadequate empirical antibiotic therapy.	—

Countries

Germany

Contacts

Public ContactCarolin Jung

Medizinische Hochschule Hannover

jung.carolin@mh-hannover.de+4917615328127

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026