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Pct and pro-adm as markers for monitoring antibiotic treatment

A technology of biomarkers and antibiotics, applied in biomaterial analysis, measuring devices, biological testing, etc., can solve problems such as accurate measurement of disease severity that has not yet been shown, and achieve the effect of improving medical care and avoiding costs

Pending Publication Date: 2020-05-01
BRAHMS GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, an accurate measure of disease severity has not been shown

Method used

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  • Pct and pro-adm as markers for monitoring antibiotic treatment
  • Pct and pro-adm as markers for monitoring antibiotic treatment
  • Pct and pro-adm as markers for monitoring antibiotic treatment

Examples

Experimental program
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Effect test

example 1

[0445] Example 1: Patient Characteristics

[0446] Table 1 summarizes patient characteristics at study enrollment.

[0447]A total of 1089 patients with severe sepsis (13.0%) or septic shock (87.0%) were analyzed, of which 445 (41.3%) and 633 (58.7%) patients also met sepsis-3 and septic shock-3, respectively standard. The mean age of the registered patients was 65.7 (13.7) years old, and the mean SOFA score was 10.0 (3.3) points. The 28-day all-cause mortality rate (N=1076) was 26.9% (sepsis-3: 20.0%; septic shock-3: 32.1%), and the in-hospital mortality rate was 33.4% (sepsis-3: 24.4%; Toxic shock-3: 40.4%). 836 patients (77.7%) were found to have infections originating from a single lesion, among them, pulmonary (N=324; 30.1%), intra-abdominal (N=252; 23.4%), genitourinary (N=57; 5.3%) and bone / soft tissue (N=50; 4.6%) origin were most prevalent. The corresponding mortality rates were 26.5%, 24.6%, 22.8% and 28.0%, respectively. Multiple sources of infection were foun...

example 2

[0448] Example 2: Relationship of Baseline Biomarkers and Clinical Scores to Mortality

[0449] Univariate and multivariate Cox regression analyzes found that MR-proADM was most strongly associated with 28-day mortality in the overall patient population and in the sepsis-3 and septic shock-3 subgroups (Table 2). The corresponding AUROC analysis found significant differences in all biomarkers and clinical scores compared with MR-proADM, except APACHE II (subgroup of patients with sepsis-3).

[0450] Similar results were found for 7-day, 90-day, ICU, and in-hospital mortality prediction (Table 3), with the addition of MR-proADM to all potential biomarker and clinical score combinations (N=63) significantly improving the prognostic power (Table 4).

example 3

[0451] Example 3: Identification of high-risk patients

[0452] The total patient population was further stratified according to existing SOFA severity levels, as well as biomarker and clinical score performance in predicting 28-day mortality assessed in each subgroup. MR-proADM showed the highest accuracy for all parameters in the low (SOFA ≤ 7) and moderate (8 ≤ SOFA ≤ 13) severity SOFA subgroups (Table 5; Table 6).

[0453] Two corresponding MR-proADM cutoffs were then calculated to identify low (≤2.7 nmol / l) and high (>10.9 nmol / l) severity subgroups at baseline. Compared with SOFA, it can be found in low (MR-proADM / SOFA: N=265 / 232; 9.8% / 13.8% mortality) and high (MR-proADM / SOFA: N=161 / 155; 55.9% / 41.3%) A more precise reclassification was performed under the severity cutoff (Table 7).

[0454] The subgroup of 94 patients (9.3%) with high MR-proADM concentrations and corresponding low or intermediate SOFA values ​​had mortality rates of 57.4% and 68.9% at 28 and 90 days, ...

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Abstract

The invention relates to a method for antibiotic therapy guidance, stratification and / or control in a patient suffering from an infectious disease and receiving treatment with one or more antibiotic agents. In particular, the method comprises isolating a first sample from said patient, isolating a second sample from said patient after isolating the first sample and initiating antibiotic treatment,determining levels of procalcitonin (PCT) or fragment(s) thereof in the first and the second sample, and determining a level of proadrenomedullin (proADM) or fragment(s) thereof in at least the second sample, wherein the levels of PCT or fragment(s) thereof in said first and second samples, and the level of pro ADM or fragment(s) thereof in the second sample, are indicative of whether a change inthe treatment with one or more antibiotic agents is required. In a preferred embodiment of the invention, the method comprises additionally determining a level of pro ADM or fragment(s) thereof in the first and second samples. In a preferred embodiment of the invention changes in the pro ADM and PCT levels between the first and second samples indicate a need for changing or maintaining the antibiotic treatment. Furthermore, the invention also relates to a kit for carrying out the method of the present invention.

Description

[0001] The present invention relates to a method for antibiotic therapy guidance, stratification and / or control in patients suffering from an infectious disease and receiving one or more antibiotic therapy. In particular, the method comprises isolating a first sample from said patient, isolating a second sample from said patient after isolating the first sample and initiating antibiotic therapy, determining procalcitonin in the first sample and in the second sample (PCT) or a fragment thereof, and determining the level of proadrenomedullin (proADM) or a fragment thereof in at least a second sample, wherein PCT or a fragment thereof in said first and second samples The level, and the level of the proADM or its fragment in the second sample, indicate whether need to change the treatment of one or more antibiotics. In the preferred embodiment of the present invention, the method also comprises measuring first sample and second Levels of proADM or fragments thereof in the samples. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/569
CPCG01N33/56911G01N2800/52G01N33/74G01N2800/26
Inventor D·威尔逊
Owner BRAHMS GMBH
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