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Granzyme A in Patients With E. Coli Bacteremic Urinary Tract Infections

NCT03991793 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2019-06-19

No results posted yet for this study

Summary

Background: Survival in Granzyme A gene (gzmA) knocked-out mice was significantly longer than in wild-type mice in a murine peritonitis model (cecal ligation puncture).

Hypothesis: GZM A has a pathogenic role in sepsis in humans and gzmA polymorphisms can help to predict the risk of sepsis among patients with systemic infections (E. coli bacteremic urinary tract infections).

Objectives:

1. To assess the correlation between GZM A serum levels and systemic inflammatory response in a human model of infection/sepsis (E. coli bacteremic UTI)
2. To characterize gzmA polymorphisms among patients with E. coli bacteremic UTI
3. To determine GZM A serum kinetics among patients with E. coli bacteremic UTI
4. To characterize E. coli strains causing bacteremic UTI: antimicrobial phenotype and virulence factors ("virulome").

Methods:

* Design and setting: Prospective nested case-control study
* Study population: consecutive adult patients with bacteremic urinary tract infections (UTIs) caused by E. coli
* Exclusion criteria: Patients with conditions that significantly compromise immune status or patients exposed to urologic procedures
* Estimated sample size: 50 patients with a sepsis/ non sepsis 1:1 ratio. Septic and non septic patients will be matched on gender, age (+/- 10 years), comorbidity (Charlson score +/-1), time symptom onset to blood culture (+/- 24h)
* Measurements: GZM A serum levels will be determined on day 0, day 2-3, day 30. GZM A kinetics, gzmA polymorphisms (whole exome sequencing).Whole genome sequencing of E. coli isolates retrieved from blood cultures will be performed.
* Analysis: Association between GZM A levels and gzmA polymorphisms and sepsis will be analyzed adjusting for patient, infection and microorganism-related factors (multivariate analysis).

Conditions

  • Bloodstream Infection
  • Sepsis
  • Pathogenesis
  • Escherichia Coli Bacteremia

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria Aragón

    lead OTHER

Principal Investigators

  • José Ramón P Paño-Pardo · Instituto de Investigación Sanitaria Aragon

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2020-05-30
Completion
2020-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03991793 on ClinicalTrials.gov