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NCT03991793: GABEC
Granzyme A in Patients With E. Coli Bacteremic Urinary Tract Infections
trial in Bloodstream Infection in 50 participants. Status unknown.
30 May 2020
Quick facts
| Lead sponsor | Instituto de Investigación Sanitaria Aragón |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 20 June 2019 |
| Primary completion | 30 May 2020 |
| Estimated completion | 31 December 2020 |
Conditions studied
- Bloodstream Infection — all drugs for Bloodstream Infection →
- Sepsis — all drugs for Sepsis →
- Pathogenesis — all drugs for Pathogenesis →
- Escherichia Coli Bacteremia — all drugs for Escherichia Coli Bacteremia →
Sponsor
Instituto de Investigación Sanitaria Aragón — full company profile →
Who can join
18 and older, any sex, with Bloodstream Infection or Sepsis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03991793 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto de Investigación Sanitaria Aragón
- Last refreshed: 19 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03991793.
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