A multidisciplinary approach to identify and analyse not only the causes but also the risk factors for increased mortality in invasive infections caused by Streptococcus pyogenes

A multidisciplinary investigation of molecular mechanisms and clinical risk factors predicting increased mortality in invasive Streptococcus pyogenes infections

Registry ID
ISRCTN52769435
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
General University Hospital in Prague
Enrollment
45
Start date
2025-05-23
Completion date
2028-12-31
Last update
2026-08-17

Conditions

Summary

Streptococcus pyogenes infection

Detailed description

This is a multicentre, prospective, non-interventional cohort study. The enrolment will take place in three centres in the Czech Republic. We plan to enrol 300 adult patients in total. Patients over 18 years of age with evidence of skin and soft tissue infection or unclear origin caused by S. pyogenes are enrolled in the study. In patients admitted with signs of infection and possible streptococcal aetiology, blood cultures are taken, standard biomarkers are collected. Patients are assigned a protocol number so that blood samples can be preserved for possible further analysis if the aetiology of S. pyogenes is confirmed. S. pyogenes is identified by latex agglutination and matrix-assisted laser desorption and ionization time-of-flight mass spectrometry. For all strains of S. pyogenes isolated from patients with invasive infection, minimum inhibitory concentration of selected antibiotics will be determined by gradient strip method. To identify virulence factor(s), molecular genetic approaches including whole genome sequencing, transcriptomics and comparative proteomics will be used. Biomarkers and immunological markers levels are measured in a hospital laboratory using commercially available assays as part of routine care. In the case of a confirmed S. pyogenes aetiology, biomarkers and special immunological markers will be tested from stored samples.

Interventions

Inclusion criteria

1. Aged >18 years 2. Invasive S. pyogenes infections 3. Skin and soft tissue infections caused by S. pyogenes

Exclusion criteria

1. Aged <18 years 2. Other bacterial finding in blood cultures and clinically valid samples than S. pyogenes

Locations

Related clinical trials

View on source registry