- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02848534
The Value of the Neutrophil to Lymphocyte Ratio in the Diagnosis of Bacterial Infections (RNL-MI)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens Picardie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI2015-40 Schmidt-2
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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