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Antibiotic therapy guidance based on procalcitonin in patients with comorbidities

A technology of antibiotics and comorbidities, applied in the field of test kits for implementing the method of the present invention, can solve problems such as changes in the critical level of PCT

Pending Publication Date: 2020-09-11
BRAHMS GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Clinicians face additional challenges in determining the timing of dosing antibiotics or modifying their use (e.g. escalation) or other biological conditions of the patient, specifically when the subject exhibits one or more innate immune Conditions of impaired response, especially when the subject exhibits one or more conditions of impaired innate immune response, which may result in the established cut-off levels of PCT in patients without such additional concurrent disorders change

Method used

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  • Antibiotic therapy guidance based on procalcitonin in patients with comorbidities
  • Antibiotic therapy guidance based on procalcitonin in patients with comorbidities
  • Antibiotic therapy guidance based on procalcitonin in patients with comorbidities

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0314] Example 1: Patient characteristics

[0315] A total of 213 patients were enrolled in the study, of which 113 patients (53.1%) developed severe sepsis within the first 48 hours after presentation, and 7 patients (6.9%) suffered from septic shock. The average age of the total population is 67.8 years, and there is no significant difference between the sexes (50.2% for men). The patients showed high comorbidities, including hypertension (42.2%), anemia (35.4%), coronary heart disease (22.3%), chronic obstructive pulmonary disease (18.4%) and diabetes (17.0%). 190 (89.2%) patients can establish the source of infection, of which lung (N=85; 39.9%), urinary tract (N=53; 24.9%) and soft tissue or skin (N=21; 9.9%) infection are the most prevalent. The 28-day total mortality of the total population was 8.9%, and 203 (95.3%) patients had SOFA score ≤ 6 points. Compared with survivors, all biomarkers and clinical scores of non-surviving patients are significantly higher. Non-surv...

example 2

[0317] Example 2: Using biomarkers as an aid to assess antibiotic needs

[0318] A total of 187 patients (87.8%) were treated with antibiotics in the study population. Of these patients, 164 (77.0%) received only intravenous antibiotics, 6 (2.8%) received only a combination of intravenous and oral antibiotics, and 17 (8.0%) received only oral antibiotics. Supplementary Table 2 provides a comprehensive overview of intravenous antibiotics. The median time of initial intravenous antibiotic therapy was 93 [28-160] minutes, of which 71 (43.8%) patients received initial antibiotic therapy within 60 minutes.

[0319] Logistic regression analysis indicated that of the two regression models, MR-proADM was most closely related to the need for intravenous antibiotics (Table 3). Similar results were found for PCT, and the ratio of the two markers was greater than that of CRP or lactic acid. Adding PCT or MR-proADM to the multivariate model significantly improved the predictive value of anti...

example 3

[0322] Example 3: The added value of the combination of PCT and MR-proADM to predict the need for intravenous antibiotics

[0323] Compared with the logistic regression analysis of a single biomarker alone and a multivariate model including the patient’s age and gender, PCT (Table 6) was added to the MR-proADM multivariate model (age + gender). -The proADM (age + gender) of the PCT-PCT multivariate model (Table 7) has been added to the proADM multivariate model. MR-proADM adds more values ​​to the PCT to predict the need for intravenous antibiotics (such as LR 2 The higher the value and the lower the p-value, the more significant its significance) than PCT has a greater impact on MR-proADM. However, both combinations are significant.

[0324] When patients who were previously treated with antibiotics (thus artificially lowering the PCT concentration when reaching ED) were excluded from the analysis, as shown in Table 8 for a single marker alone and Table 9 for a multivariate model ...

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Abstract

The invention relates to a method for antibiotic therapy guidance, stratification and / or control in a patient with one or more comorbidities comprising an impaired innate immune response and suspectedof having an infection. The method also relates to a method for antibiotic therapy guidance, stratification and / or control in a patient with one or more comorbidities comprising an impaired innate immune response, wherein the comorbidity is preferably selected from the group comprising metabolic disorder (obesity), diabetes, hypertension, renal disease, thrombosis, malignancy or cancer, and suspected of having an infection. In particular, the method comprises providing a sample from said patient and determining a level of PCT or fragment(s) thereof in said sample, wherein the level of PCT orfragment(s) thereof in said sample is indicative of whether an initiation or a change of an antibiotic treatment is required. Furthermore, the invention also relates to a kit for carrying out the method of the present invention.

Description

technical field [0001] The present invention relates to a method for antibiotic therapy guidance, stratification and / or control in patients with one or more comorbidities including impaired innate immune response and suspected infection. The method also relates to a method for antibiotic therapy guidance, stratification and / or management in patients with one or more comorbidities including impaired innate immune response, wherein said comorbidities are preferably is selected from the group comprising: metabolic disorder (obesity), diabetes, hypertension, kidney disease, thrombosis, malignancy or cancer, and suspected infection. In particular, the method comprises providing a sample from the patient and determining the level of PCT or a fragment thereof in the sample, wherein the level of PCT or a fragment thereof in the sample is indicative of the need to initiate or alter antibiotic therapy. Furthermore, the invention also relates to kits for carrying out the methods of the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/50G01N33/74
CPCG01N33/502G01N33/74G01N2333/585G01N2800/26G01N2800/52A61K45/06
Inventor D·威尔逊S·基尔希
Owner BRAHMS GMBH