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The Value of the Neutrophil to Lymphocyte Ratio in the Diagnosis of Bacterial Infections (RNL-MI)

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ClinicalTrials.gov Identifier: NCT02848534
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

The "gold standard" for diagnosing a bacterial infection is isolation of the pathogenic germ, which is not easy in routine clinical practice.

Conventional markers do not have sufficient diagnostic value for making a rapid diagnosis on admission. A 2004 literature calculated the diagnostic values of C-reactive protein (CRP) and procalcitonin (PCT) levels for the diagnosis of bacterial infections, relative to other causes of inflammation. For CRP, the sensitivity was 75% (95% CI: 62%-84%) and the specificity was 67% (95% CI: 56%-77%). For PCT, the sensitivity was 88% (95% CI: 62%-84%) and the specificity was 81% (95% CI: 67%-90%).

The first cellular immune response to infection consists of the mobilization of polynuclear neutrophils from the bone marrow to the infection site under the effect of pre-inflammatory cytokines, as well as the apoptosis of lymphocytes and their sequestration at the infection site. This results in lymphopenia and the elevated polynuclear neutrophil count (PNN) observed in bacterial infections.

Hence, it is legitimate to hypothesize that the neutrophil to lymphocyte ratio (NLR) can be used in the diagnosis of bacterial infection. This ratio's value in the diagnosis of sepsis in the emergency department was studied and the researchers found higher diagnostic values than for CRP and PCT.

The NLR's potential value in the diagnosis of a bacterial infection in a context of fever or hyperthermia (regardless of the presence or absence of bacteraemia) has not been studied before. This ratio could also be compared with standard biomarkers (CRP and PCT levels, the white blood cell count and the PNN).


Condition or disease Intervention/treatment
Bacterial Infections Biological: neutrophil to lymphocyte ratio

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Study Type : Observational
Actual Enrollment : 479 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Value of the Neutrophil to Lymphocyte Ratio in the Diagnosis of Bacterial Infections
Actual Study Start Date : February 6, 2016
Actual Primary Completion Date : September 12, 2016
Actual Study Completion Date : September 12, 2016

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Intervention Details:
  • Biological: neutrophil to lymphocyte ratio
    value of the neutrophil to lymphocyte ratio in the diagnosis of bacterial infections


Primary Outcome Measures :
  1. NLR / CRP [ Time Frame: 1 day ]
    To compare the NLR with other commonly used inflammatory markers for the diagnosis of bacterial infection in patients admitted for fever and/or inflammatory syndrome to an internal medicine department.

  2. NLR / PCT [ Time Frame: 1 day ]
    To compare the NLR with other commonly used inflammatory markers for the diagnosis of bacterial infection in patients admitted for fever and/or inflammatory syndrome to an internal medicine department.

  3. NLR / white blood cell count [ Time Frame: 1 day ]
    To compare the NLR with other commonly used inflammatory markers for the diagnosis of bacterial infection in patients admitted for fever and/or inflammatory syndrome to an internal medicine department.

  4. NLR / PNN [ Time Frame: 1 day ]
    To compare the NLR with other commonly used inflammatory markers for the diagnosis of bacterial infection in patients admitted for fever and/or inflammatory syndrome to an internal medicine department.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All consecutive patients admitted for fever/inflammatory syndrome to the internal medicine department at Amiens University Hospital between January 1 st 2011 and December 31 st 2014 (hyperthermia > 38°5 and/or inflammatory syndrome, defined as an increase in CRP

>10 mg/L).

Criteria

Inclusion Criteria:

  • All consecutive patients admitted for fever/inflammatory syndrome to the internal medicine department at Amiens University Hospital between January 1 st 2011 and December 31 st 2014 (hyperthermia > 38°5 and/or inflammatory syndrome, defined as an increase in CRP >10 mg/L).

Exclusion Criteria:

  • Known conditions or treatments that may influence the blood count (haematological and neoplastic diseases, seropositivity for HIV, chemotherapy, and corticotherapy).
  • Pregnancy.
  • A course of antibiotics administered in the 48 hours before the
  • blood count (risk of sample negativity).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848534


Locations
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France
CHU Amiens Picardie
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Jean Schmidt, MD CHU Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02848534     History of Changes
Other Study ID Numbers: RNI2015-40 Schmidt-2
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
fever
hyperthermia
inflammatory syndrome
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections