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

August 9, 2018 updated by: Centre Hospitalier Universitaire, Amiens

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).

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

479

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens, France, 80054
        • CHU Amiens Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
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.
1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 6, 2016

Primary Completion (ACTUAL)

September 12, 2016

Study Completion (ACTUAL)

September 12, 2016

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (ESTIMATE)

July 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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