INfectious DIsease REgistry BIObank

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Patients with specific infectious diseases followed at the IRCCS San Raffaele Hospital (either as inpatients or outpatients).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Clinical characteristics of specific infectious diseases

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).

Time frame
6 months (with the exception of people living with HIV)
2

Microbiological characteristics of specific infectious diseases

Describe the microbiological characteristics of specific infectious diseases. Specifically: * Identification of the causative organisms * Antimicrobial susceptibility testing results * Mechanism of resistance

Time frame
6 months (with the exception of people living with HIV)
3

Treatment of specific infectious diseases

Describe the antimicrobial treatment of specific infectious diseases

Time frame
6 months (with the exception of people living with HIV)

Secondary outcomes

1

Predictive factors of microbiological cure

Describe the predictive factors of microbiological cure, defined as negativization of cultures from the infected site

Time frame
6 months (with the exception of people living with HIV)
2

Predictive factors of clinical cure

Describe the predictive factors of clinical cure, defined as resolution of symptoms and signs attributable to the specific infectious disease

Time frame
6 months (with the exception of people living with HIV)
3

Need for surgical intervention or other procedures

Describe the number of patients needing surgical intervention or other procedures

Time frame
6 months (with the exception of people living with HIV)
4

Need for ICU

Describe the number of patients needing ICU transfer

Time frame
6 months (with the exception of people living with HIV)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele

Lead sponsor

Ospedale San Raffaele

Sponsor institution