Pneumonia Clinical Trial
— BIOARTEOfficial title:
Development Of A Non-Interventional Diagnostic Ngs-Based Assay Of Blood Samples Of Sepsis Patients For Rapid Bacterial Identification Based On Next Generation Sequencing.
NCT number | NCT06141395 |
Other study ID # | BIOARTE |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 16, 2023 |
Est. completion date | March 14, 2024 |
Verified date | December 2023 |
Source | Hellenic Institute for the Study of Sepsis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 14, 2024 |
Est. primary completion date | March 14, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - Age below 18 years. - Denial for written informed consent. - Patients already receiving antibiotics. - Pregnancy or lactation. |
Country | Name | City | State |
---|---|---|---|
Greece | 1st Department of Internal Medicine, General Hospital of Eleusis THRIASIO | Athens | |
Greece | 3rd University Department of Internal Medicine, General Hospital of Chest Diseases of Athens SOTIRIA | Athens | |
Greece | 4th Department of Internal Medicine,"Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School | Chaïdári | Attiki |
Greece | 3rd Department of Internal Medicine, General Hospital of Nikaia AGIOS PANTELEIMON | Nikaia |
Lead Sponsor | Collaborator |
---|---|
Hellenic Institute for the Study of Sepsis | The BioArte |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Difference in time to identification of the bacterial pathogen between Next Generation Sequencing and the Standard-of-Care culture | The time from start of incubation until final identification will be recorded and compared between the two methods. | 7 days | |
Secondary | Difference in time to Antibiotic Susceptibility Testing between Next Generation Sequencing and the Standard-of-Care culture | The time from start of incubation until the Antibiotic Susceptibility Testing will be recorded and compared between the two methods. | 7 days |
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