NCT02848534

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
479

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2016

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

July 26, 2016

Last Update Submit

August 9, 2018

Conditions

Keywords

feverhyperthermiainflammatory syndrome

Outcome Measures

Primary Outcomes (4)

  • NLR / CRP

    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

    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

    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

    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

Interventions

value of the neutrophil to lymphocyte ratio in the diagnosis of bacterial infections

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, 80054, France

Location

MeSH Terms

Conditions

Bacterial InfectionsFeverHyperthermia

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Officials

  • Jean Schmidt, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

July 28, 2016

Study Start

February 6, 2016

Primary Completion

September 12, 2016

Study Completion

September 12, 2016

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations