NCT06418048

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
222mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Feb 2024Jul 2044

First Submitted

Initial submission to the registry

January 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
19.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2044

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2044

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

20 years

First QC Date

January 31, 2024

Last Update Submit

April 15, 2026

Conditions

Bloodstream InfectionsCentral Nervous System InfectionsBone and Joint InfectionsEndovascular InfectionsInfective EndocarditisCIED-related InfectionsVertebral Osteomyelitis

Outcome Measures

Primary Outcomes (3)

  • 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).

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

  • 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

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

  • Treatment of specific infectious diseases

    Describe the antimicrobial treatment of specific infectious diseases

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

Secondary Outcomes (10)

  • 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)

  • Need for surgical intervention or other procedures

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

  • 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)

  • +5 more secondary outcomes

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

  • \- Participants who are unable to understand the study protocol or are unable to give informed consent, and have no legal representative.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Scientific Institute

Milan, Italy

RECRUITING

Related Publications (1)

  • Ripa M, Galli L, Cinque P, Nozza S, Spagnuolo V, Tassan Din C, Guffanti M, Lolatto R, Piromalli G, Carletti S, Locatelli M, Sanvito F, Ponzoni M, Cantarelli E, Tresoldi C, Castagna A; INDI-REBIO Study Group. The INfectious DIsease REgistry BIObank (INDI-REBIO): protocol for the design and implementation of a single-centre, prospective registry and biobank in a tertiary care centre in Italy for advancing infectious disease research. BMJ Open. 2025 Aug 12;15(8):e091113. doi: 10.1136/bmjopen-2024-091113.

    PMID: 40803735DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Blood * Cerebrospinal fluid (CSF) * Respiratory specimens * Synovial fluid * Urine * Stool * Seminal fluid * Tissue samples * Microbial isolates

MeSH Terms

Conditions

SepsisCentral Nervous System InfectionsEndocarditis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System DiseasesNervous System DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Marco Ripa, MD

    IRCCS San Raffaele Scientific Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabetta Carini

CONTACT

+390226437934carini.elisabetta@hsr.it

Sabrina Bagaglio

CONTACT

+390226432276bagaglio.sabrina@hsr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

January 31, 2024

First Posted

May 16, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

January 31, 2044

Study Completion (Estimated)

July 31, 2044

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations

IT(1)