Prospective Registry and Biobank of Patients With Infectious Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- Treatment of specific infectious diseases
Study Overview
Brief Summary
Prospective observational study designed to describe the clinical, laboratory, imaging, microbiological characteristics and treatment of specific infectious diseases, with the addition of a dedicated biobank.
Detailed Description
The registry would provide a comprehensive database including a vast population of patients with infectious diseases, favoring the analysis of clinical, laboratory and therapeutic data of specific infectious conditions.
Specific infectious diseases of major interest include, among others:
- Bloodstream infections (i.e.: infectious syndromes manifesting with bacteremia)
- Endovascular infections (i.e.: infective endocarditis, cardiovascular implantable electronic device infections, vascular graft infections, etc.)
- Central nervous system infections (i.e.: meningitis, encephalitis, cerebral abscess, ventricular shunts infections, etc.)
- Bone and joint infections (i.e.: osteomyelitis, spondylodiscitis, prosthetic joint infections, etc.)
- Sexually transmitted infections (i.e.: gonococcal and non-gonococcal urethritis, proctitis, epididymo-orchitis, syphilis, etc.)
- HIV infection
- Emerging and re-emerging infectious diseases.
General objectives of the study for each specific infectious disease include:
- description and evolution over time of clinical and laboratory characteristics of patients with specific infectious diseases;
- description and evolution over time of microbial isolates, including antimicrobial susceptibility testing;
- description and evolution over time of treatment employed in patients with specific infectious diseases;
- evaluation of predictive factors for treatment success and mortality in patients with specific infectious diseases;
- description, evaluation and prognostic impact of microbial, immunological and inflammatory biomarkers.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with clinically suspected or microbiologically documented infectious diseases (bacterial, viral, fungal or parasitic);
- •At least 18 years of age or older;
- •Able to provide informed consent;
- •Participants who are unable to understand the study protocol or are unable to give informed consent, but have a legal representative
Exclusion Criteria
- •- Participants who are unable to understand the study protocol or are unable to give informed consent, and have no legal representative.
Outcomes
Primary Outcomes
Treatment of specific infectious diseases
Time Frame: 6 months (with the exception of people living with HIV)
Describe the antimicrobial treatment of specific infectious diseases
Clinical characteristics of specific infectious diseases
Time Frame: 6 months (with the exception of people living with HIV)
Describe the clinical presentation of specific infectious diseases, by means of Sequential Organ Failure Assessment (SOFA) score (minimum 0 - maximum 24; higher scores linked to worse outcome).
Microbiological characteristics of specific infectious diseases
Time Frame: 6 months (with the exception of people living with HIV)
Describe the microbiological characteristics of specific infectious diseases. Specifically: * Identification of the causative organisms * Antimicrobial susceptibility testing results * Mechanism of resistance
Secondary Outcomes
- Need for ICU(6 months (with the exception of people living with HIV))
- Overall mortality(6 months (with the exception of people living with HIV))
- Infection-attributable mortality(6 months (with the exception of people living with HIV))
- Predictive factors of microbiological cure(6 months (with the exception of people living with HIV))
- Predictive factors of clinical cure(6 months (with the exception of people living with HIV))
- Neurological impairment(6 months (with the exception of people living with HIV))
- Development of comorbidities(6 months (with the exception of people living with HIV))
- Need for surgical intervention or other procedures(6 months (with the exception of people living with HIV))
- Functional impairment(6 months (with the exception of people living with HIV))
- Development of drug toxicity(6 months (with the exception of people living with HIV))
Investigators
Castagna Antonella
Full Professor
Ospedale San Raffaele