NCT03943277

Brief Summary

In the general population, increased WBCC and neutrophil count are widely used as markers for infection during inflammatory states 1. However, 32% of geriatric patients with an infection do not develop an increase in WBCC 2. The hypothesis is that with inflammation, geriatric patients have a misadapted response of the immune system (IS) 3. Our recent retrospective study 4 has shown that total and differential WBCC were not correlated with infection in a geriatric hospitalized population. Therefore, WBCC does not seem to be a reliable marker for infection in geriatric hospitalized patients. The neutrophil/lymphocyte ratio, and CRP, seem to be better markers. the aim of the study to investigate this hypothesis prospectively and assess the role of aging and chronic diseases (such as cardiovascular diseases (CVD) and risk factors (CVRF) 5, cytomegalovirus (CMV) infection 6, periodontitis 7, onychomycosis 8 ) in this process and assess the role of a geriatric assessment. To assess the usefulness of WBCC in the diagnosis of infection in geriatric patients and to address the contribution of ongoing chronic co-morbidities and age to WBCC-kinetics during an acute inflammatory syndrome, young and geriatric hospitalized patients with an inflammatory syndrome with and without infection will be compared

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Longer than P75 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

First Submitted

Initial submission to the registry

April 25, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

5.1 years

First QC Date

April 25, 2019

Last Update Submit

December 4, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Usefulness of white blood cell count (WBCC) during infection in geriatric patient

    observation of WBCC is correlated with infection by older patient

    1.5 years

  • Delta of wbcc

    the significance of a Delta of WBCC (Delta= □((White blood cell count during acute infection or acute inflammatory events)/(White blood cell count in chronic circumstances)) ) in geriatric patients with acute infections or inflammatory events

    1.5 years

Study Arms (2)

patient with infection

Acute inflammation is defined as a CRP ≥ 10 mg/l. We will include 2 groups of participants: A group with an inflammatory syndrome and infection; infection being defined as: 1. Viral infection confirmed by nasopharynx swab for: influenza, RSV, parainfluenza, rhinovirusses, coronavirusses. 2. Bacterial infection confirmed with positive blood culture, positive articular punction, positive expectorations, pneumonia on chest radiograph, or infection documented by abdominal imagery (CT or echo), a positive urine culture with a confirmed pyelonephritis with a renal echography or a DMSA scintigraphy or specific clinical symptoms for pyelonephritis and positive hemoculture. A positive urine culture alone is not considered as urine infection because of the high prevalence of asymptomatic bacteriuria in geriatric patients.

Other: No intervention, observational study

patient without infection

Acute inflammation is defined as a CRP ≥ 10 mg/l. We will include 2 groups of participants: =\> B) A group with inflammatory syndrome and inflammatory diseases without infection: defined as: 1. Confirmed pulmonary embolism (PE) by CT or ventilation-perfusion scintigraphy 2. Microcrystalline arthritis diagnosed by articular punction 3. Crush syndrome or rhabdomyolyses defined by history of a fall and raised creatine kinase in blood sample.

Other: No intervention, observational study

Interventions

No intervention observational study

patient with infectionpatient without infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Young and older patient with an inflammatory syndrome (CRP \> 10 mg/dl) with or without infection

You may qualify if:

  • Acute inflammation is defined as a CRP ≥ 10 mg/l. We will include 2 groups of participants:
  • A) A group with an inflammatory syndrome and infection; infection being defined as:
  • Viral infection confirmed by nasopharynx swab for: influenza, RSV, parainfluenza, rhinovirusses, coronavirusses.
  • Bacterial infection confirmed with positive blood culture, positive articular punction, positive expectorations, pneumonia on chest radiograph, or infection documented by abdominal imagery (CT or echo), a positive urine culture with a confirmed pyelonephritis with a renal echography or a DMSA scintigraphy or specific clinical symptoms for pyelonephritis and positive hemoculture. A positive urine culture alone is not considered as urine infection because of the high prevalence of asymptomatic bacteriuria in geriatric patients.
  • B) A group with inflammatory syndrome and inflammatory diseases without infection: defined as:
  • Confirmed pulmonary embolism (PE) by CT or ventilation-perfusion scintigraphy
  • Microcrystalline arthritis diagnosed by articular punction
  • Crush syndrome or rhabdomyolyses defined by history of a fall and raised creatine kinase in blood sample.

You may not qualify if:

  • Immunosuppressive therapy (NSAIDs, corticosteroids, chemotherapy, immunotherapy), active cancer, antibiotics before admission, hematological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

Related Publications (2)

  • Compte N, Dumont L, Bron D, De Breucker S, Praet JP, Bautmans I, Pepersack T. White blood cell counts in a geriatric hospitalized population: A poor diagnostic marker of infection. Exp Gerontol. 2018 Dec;114:87-92. doi: 10.1016/j.exger.2018.11.002. Epub 2018 Nov 6.

  • Compte N, Bailly B, De Breucker S, Goriely S, Pepersack T. Study of the association of total and differential white blood cell counts with geriatric conditions, cardio-vascular diseases, seric IL-6 levels and telomere length. Exp Gerontol. 2015 Jan;61:105-12. doi: 10.1016/j.exger.2014.11.016. Epub 2014 Nov 22.

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Compté Nathalie, Dr, PhD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinic head of geriatric unit

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 9, 2019

Study Start

May 20, 2019

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

data will be maybe described in an article

Locations