Web-based program for anti-infective treatment using evidence-based algorithms adapted to local resistance rates

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN54598675

Enrollment

8000

Registered

2007-10-04

Start date

2006-01-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Critical illness Signs and Symptoms Critical illness

Interventions

Intended duration: 36 months - 1. 12 months: conversion of the user-accepted SOPs into a web-based version for each participating centre including evidence-based medicine and local resistance rates 2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients admitted to five ICUs at Universitaetsmedizin Charite at Campus Mitte and Campus Virchow-Klinikum

Exclusion criteria

Exclusion criteria: 1. Patients under age of 18 2. Length of ICU stay less than 36 hours 3. Non-existing guideline for particular disease

Design outcomes

Primary

Measure	Time frame
1. Implementation rate of SOPs before and after support of web-based computer program 2. Mortality rate with and without adherence to SOPs Proof of the two primary endpoints in the sense of multiple testing with alpha/2 = 2.5% (Bonferroni's adjustment), i.e., with an error of the first kind of 2.5% each. A drop-out of 10% will be incorporated. Ongoing outcome measurements in three months intervals including data collection and subsequent three months periods of data interpretation, comparison, and assessment.	—

Measure

Time frame

1. Implementation rate of SOPs before and after support of web-based computer program 2. Mortality rate with and without adherence to SOPs Proof of the two primary endpoints in the sense of multiple testing with alpha/2 = 2.5% (Bonferroni's adjustment), i.e., with an error of the first kind of 2.5% each. A drop-out of 10% will be incorporated. Ongoing outcome measurements in three months intervals including data collection and subsequent three months periods of data interpretation, comparison, and assessment.

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Secondary

Measure	Time frame
1. Infections with multi-resistant bacteria 2. Beginning and duration of anti-infective therapy 3. Length of infection induced organ failure (ventilator days, Sequential Organ Failure Assessment [SOFA] scores) 4. Duration of ICU treatment including rate of admissions to other ICUs 5. Length of ICU stay Ongoing outcome measurements in three months intervals including data collection and subsequent three months periods of data interpretation, comparison, and assessment. An exploratory data analysis is planned for the assessment of the secondary outcome measures and risk factor analysis.	—

Measure

Time frame

1. Infections with multi-resistant bacteria 2. Beginning and duration of anti-infective therapy 3. Length of infection induced organ failure (ventilator days, Sequential Organ Failure Assessment [SOFA] scores) 4. Duration of ICU treatment including rate of admissions to other ICUs 5. Length of ICU stay Ongoing outcome measurements in three months intervals including data collection and subsequent three months periods of data interpretation, comparison, and assessment. An exploratory data analysis is planned for the assessment of the secondary outcome measures and risk factor analysis.

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026