NCT06141395

Brief Summary

Rapid detection of microorganisms is a promising approach towards early administration of appropriate antibiotics for sepsis. This study aims to investigate the potential of a new NGS platform for the rapid diagnosis of circulating bacteria in blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

November 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2024

Completed
Last Updated

March 29, 2024

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

November 15, 2023

Last Update Submit

March 28, 2024

Conditions

PneumoniaAcute PyelonephritisBacteremiaBiliary Tract Infection

Keywords

Bacterial InfectionAntimicrobial susceptibility testingNext generation sequencingBlood cultureTime to pathogen identification

Outcome Measures

Primary Outcomes (1)

  • The rate of matching between the results of Next Generation Sequencing and the Standard-of-Care culture for patients with sepsis.

    This will be done by assessing the sensitivity, the specificity, the positive predictive value and the negative predictive value of Next Generation Sequencing and Standard-of-Care. For the analysis of this diagnostic performance, the results of the SoC cultures will be considered the "gold standard" for comparisons.

    7 days

Secondary Outcomes (2)

  • Difference in time to identification of the bacterial pathogen between Next Generation Sequencing and the Standard-of-Care culture

    7 days

  • Difference in time to Antibiotic Susceptibility Testing between Next Generation Sequencing and the Standard-of-Care culture

    7 days

Study Arms (1)

Patients with an infection

Patients with high suspicion of infection with at least one sign of the quick Sequential Organ Failure Assessment (qSOFA) score

Diagnostic Test: NGS-based assay for bacterial identification

Interventions

NGS-based assay for bacterial identificationDIAGNOSTIC_TEST

A total volume of 26ml of whole blood will be sampled from each enrolled patient for three consecutive days. This will be used for Standard-of-Care (SoC) culture and Next Generation Sequencing (NGS), for identification of circulating microorganisms.

Patients with an infection

Eligibility Criteria

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

Patients who meet all inclusion criteria and who do not meet any exclusion criterion will be enrolled in the study.

You may qualify if:

  • Age equal to or above 18 years.
  • Both genders.
  • Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent.
  • Patients with high suspicion of infection with at least one sign of the quick SOFA score (i.e. one of mental confusion, more than 22 breaths per minute or systolic blood pressure less than 100mmHg).

You may not qualify if:

  • Age below 18 years.
  • Denial for written informed consent.
  • Patients already receiving antibiotics.
  • Pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

4th Department of Internal Medicine,"Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School

Chaïdári, Attica, 12462, Greece

Location

1st Department of Internal Medicine, General Hospital of Eleusis THRIASIO

Athens, Greece

Location

3rd University Department of Internal Medicine, General Hospital of Chest Diseases of Athens SOTIRIA

Athens, Greece

Location

3rd Department of Internal Medicine, General Hospital of Nikaia AGIOS PANTELEIMON

Nikaia, Greece

Location

MeSH Terms

Conditions

PneumoniaBacteremiaCholangitisBacterial Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesBacterial Infections and MycosesSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Evangelos Giamarellos-Bourboulis, MD,PhD

    Hellenic Institute for the Study of Sepsis

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

November 16, 2023

Primary Completion

March 14, 2024

Study Completion

March 14, 2024

Last Updated

March 29, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

GR(4)