Primary objectives:- To prospectively study and describe the aetiology, clinical management and clinical impact of atypical viral infections in immunocompromised patients in Europe- To assess the utility of metagenomics as a tool to support clinical…
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Description of the clinical characteristics and aetiologies of infectious
syndromes among the patients included in the POS;
- Analysis of variations in local practices in diagnosis and treatment of
Disease X among study sites;
Secondary outcome
- Characterization of intra-host viral evolution among immunocompromised
patients with persistent viral infections;
- Development of an infrastructure for prospective and systematic collection of
data and clinical samples in a format that can be easily aggregated, tabulated
and analysed across different participating centres;
Background summary
The COVID-19 pandemic has shown that sustained international multi-centre
observational studies and clinical trial platforms are required to reduce the
impact of emerging infectious diseases. ECRAID (European Clinical Research
Alliance for Infectious Diseases)-Base is a European consortium with the aim to
build a network for clinical research studies in the field of infectious
diseases that is ready to pivot to studies of new infectious diseases (emerging
infectious diseases, EID) if they arise. Work package 5 of ECRAID-Base is led
by the Department of Viroscience of EMC and will assess the use of a generic
protocol for inclusion of patients into an observational study for any clinical
syndrome of suspected unexplained infectious aetiology. Through this, we aim to
decrease the time to roll-out of an observational study in an emergency
situation for any rare or novel infectious disease. This so-called warm-based
study initially focuses on immunocompromised patients presenting to the
hospital with a suspected viral infection not caused by any of the most
commonly observed pathogens, or with a known viral infection with an atypical
clinical presentation. The rationale for this choice is that immunocompromised
individuals have an increased risk of developing persistent infection and of
acquiring infections with unusual pathogens. In addition, these patients have
been hypothesized to be a source of emerging virus variants with enhanced
transmissibility, immune escape, changed disease severity, or viruses that have
developed genetic resistance to antiviral treatment. Here we study viral
infections among immunocompromised patients focusing on the aetiology of
infectious disease syndromes, risk factors, and within-host viral evolution.
This will be combined with the use of novel techniques (i.e. metagenomics) for
catch-all diagnostics among participating sites and establishes a European
clinical research network for diagnostic trials.
Study objective
Primary objectives:
- To prospectively study and describe the aetiology, clinical management and
clinical impact of atypical viral infections in immunocompromised patients in
Europe
- To assess the utility of metagenomics as a tool to support clinical decision
making
- To improve laboratory diagnosis of - and preparedness for emerging viral
infections
Secondary objectives:
- To develop a clinical research network for responding to any emerging
pathogen
- To study intra-host viral evolution in the immunocompromised host
Study design
Prospective perpetual observational study (POS)
Study burden and risks
This study entails minimal harm for the study participants. In rare cases,
venipuncture can lead to complications such as hematoma or infection.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
A) >18 years old
B) Suspected infectious illness without a clear aetiology upon initial clinical
evaluation
C) Immunocompromised (Solid organ transplant recipient, OR received anti-C20
therapy in the past 9 months, OR primary immunodeficiency disorder)
D) Symptom onset <7 days
Exclusion criteria
A) Detection of a non-viral infectious agent that can explain the symptoms
B) Surgery or Intensive Care admission in the last 30 days
C Treatment with cytotoxic antineoplastic therapy in the last 30 days
D) Symptoms of urinary tract infection
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83193.078.23 |