Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418048
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-01-31
Brief Title:
INfectious DIsease REgistry BIObank
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Prospective Registry and Biobank of Patients With Infectious Diseases
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INDI-REBIO
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 ie infectious syndromes manifesting with bacteremia
Endovascular infections ie infective endocarditis cardiovascular implantable electronic device infections vascular graft infections etc
Central nervous system infections ie meningitis encephalitis cerebral abscess ventricular shunts infections etc
Bone and joint infections ie osteomyelitis spondylodiscitis prosthetic joint infections etc
Sexually transmitted infections ie 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
The general study objectives along with more specific objectives related to a specific infectious disease will be evaluated in specific observational studies nested within the Registry ie using data and biosamples collected in the Registry with the potential addition of data obtained from investigations performed on available biological samples
To achieve these objectives participants are asked to donate biological samples blood cerebrospinal fluid urine other relevant biological samples related to the specific infectious disease collected according to good clinical practice and available guidelines for studies to identify modifiers of a specific infectious disease and to establish and validate biological markers tracking the progressive course of the considered disease along with drug efficacy and toxicity
The following clinical and laboratory data will be recorded at baseline and at follow-up visits
Age measured in years
Sex at birth male female
Comorbidities measured with Charlson score minimum 0 - maximum 37 higher scores linked to worse outcome
Source of infection central nervous system respiratory tract endovascular infection intra-abdominal urinary tract skin and soft tissue bone and joint other
Sequential Organ Failure Assessment SOFA score minimum 0 - maximum 24 higher scores linked to worse outcome
Pitt Score minum 0 - maximum 14 higher scores linked to worse outcome
Length of hospital stay days
Number of patients requiring Intensive care unit ICU admission surgical interventions or other procedures
Nerological impairment Rankin scale minimum 0 - maximum 6 higher scores linked to worse outcome
Functional impairment Karnofsky scale minum 0 - maximum 100 higher scores linked to better outcome
Results of routine laboratory tests
Drug plasma concentrations
Results of microbiological investigations identification of the causative organisms antimicrobial susceptibility testing results mechanism of resistance
Results of imaging investigations
Treatment strategies type dose administration of antimicrobials
Development of drug toxicities
Mortality all-cause and infection-attributable
Both data and biosamples will be collected starting from the baseline BL of the infectious disease after obtaining informed consent Follow-up data and biosamples will be collected at the end of treatment EOT and at 6 months after the EOT for the specific condition or in case of no therapeutic intervention at 6 months after diagnosis In patients with HIV infection follow-up data and biosamples will be collected yearly after baseline Additional data and biosamples will be collected at other time-points according to the usual temporal evolution of specific diseases and in case of relevant clinical events or therapeutic modification All specimens will be collected according to good clinical practice and available national and international guidelines
Data analysis will be performed by the investigators on approved proposals Statistical methods will be defined as part of the proposals
The variables of the study will be described using means or medians and 95 confidence intervals or interquartile ranges for continuous variables and proportions with their 95 confidence intervals for categorical variables
Comparisons between groups will be made using the chi-square test or Fishers exact test categorical variables or using the non-parametric Mann-Whitney test continuous variables
Significant variations in continuous variables over time may be assessed using t-tests for paired data o Wilcoxon ranks sign test only two timepoints o analysis of variance for repeated measures or linear mixed models all timepoints available during follow-up
The presence of linear relationships between continuous variables can be tested by means of Pearson correlation coefficients parametric or Spearman correlation coefficients non-parametric
Logistic regression models will be applied to determine the predictors of outcomes the risks odds ratios and the corresponding 95 confidence intervals will be reported
Cox regression models will be applied to determine predictors of outcomes risks odds ratios and corresponding 95 confidence intervals will be reported
Specific infectious diseases of major interest include among others
Bloodstream infections ie infectious syndromes manifesting with bacteremia
Endovascular infections ie infective endocarditis cardiovascular implantable electronic device infections vascular graft infections etc
Central nervous system infections ie meningitis encephalitis cerebral abscess ventricular shunts infections etc
Bone and joint infections ie osteomyelitis spondylodiscitis prosthetic joint infections etc
Sexually transmitted infections ie 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
The general study objectives along with more specific objectives related to a specific infectious disease will be evaluated in specific observational studies nested within the Registry ie using data and biosamples collected in the Registry with the potential addition of data obtained from investigations performed on available biological samples
To achieve these objectives participants are asked to donate biological samples blood cerebrospinal fluid urine other relevant biological samples related to the specific infectious disease collected according to good clinical practice and available guidelines for studies to identify modifiers of a specific infectious disease and to establish and validate biological markers tracking the progressive course of the considered disease along with drug efficacy and toxicity
The following clinical and laboratory data will be recorded at baseline and at follow-up visits
Age measured in years
Sex at birth male female
Comorbidities measured with Charlson score minimum 0 - maximum 37 higher scores linked to worse outcome
Source of infection central nervous system respiratory tract endovascular infection intra-abdominal urinary tract skin and soft tissue bone and joint other
Sequential Organ Failure Assessment SOFA score minimum 0 - maximum 24 higher scores linked to worse outcome
Pitt Score minum 0 - maximum 14 higher scores linked to worse outcome
Length of hospital stay days
Number of patients requiring Intensive care unit ICU admission surgical interventions or other procedures
Nerological impairment Rankin scale minimum 0 - maximum 6 higher scores linked to worse outcome
Functional impairment Karnofsky scale minum 0 - maximum 100 higher scores linked to better outcome
Results of routine laboratory tests
Drug plasma concentrations
Results of microbiological investigations identification of the causative organisms antimicrobial susceptibility testing results mechanism of resistance
Results of imaging investigations
Treatment strategies type dose administration of antimicrobials
Development of drug toxicities
Mortality all-cause and infection-attributable
Both data and biosamples will be collected starting from the baseline BL of the infectious disease after obtaining informed consent Follow-up data and biosamples will be collected at the end of treatment EOT and at 6 months after the EOT for the specific condition or in case of no therapeutic intervention at 6 months after diagnosis In patients with HIV infection follow-up data and biosamples will be collected yearly after baseline Additional data and biosamples will be collected at other time-points according to the usual temporal evolution of specific diseases and in case of relevant clinical events or therapeutic modification All specimens will be collected according to good clinical practice and available national and international guidelines
Data analysis will be performed by the investigators on approved proposals Statistical methods will be defined as part of the proposals
The variables of the study will be described using means or medians and 95 confidence intervals or interquartile ranges for continuous variables and proportions with their 95 confidence intervals for categorical variables
Comparisons between groups will be made using the chi-square test or Fishers exact test categorical variables or using the non-parametric Mann-Whitney test continuous variables
Significant variations in continuous variables over time may be assessed using t-tests for paired data o Wilcoxon ranks sign test only two timepoints o analysis of variance for repeated measures or linear mixed models all timepoints available during follow-up
The presence of linear relationships between continuous variables can be tested by means of Pearson correlation coefficients parametric or Spearman correlation coefficients non-parametric
Logistic regression models will be applied to determine the predictors of outcomes the risks odds ratios and the corresponding 95 confidence intervals will be reported
Cox regression models will be applied to determine predictors of outcomes risks odds ratios and corresponding 95 confidence intervals will be reported
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None