NCCR AntiResist:: New Approaches to Combat Antibiotic-resistant Bacteria

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

This is an explorative, mono-center study including prospectively collected patient samples from the University Hospital of Basel. It is to investigate antimicrobial resistance (AMR) including three clinical manifestations of infectious diseases: urinary tract infection, pneumonia and deep-seated infections. The focus is on four bacteria (E. coli, Klebsiella species, S. aureus, P. aeruginosa) that are part of the high priority list of World Health Organization (WHO). Residual patient samples are analysed for proteomic, metabolomic and transcriptomic analysis, immunocytochemical or fluorescence in-situ hybridisation (FISH) analysis, flow cytometry analysis (FACS) and immunophenotyping and exploration of bacterial properties.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

E. coli

Klebsiella species

S. aureus

P. aeruginosa

Disqualifiers

Patients who have refused research and reuse of their data/samples (e.g. general consent) or any other decline (e.g. Patientenverfügung).

other than one of the focus bacteria in routine microbiology lab

Age: <18 years

Controls without signed general consent

Trial population

Patient samples during routine collection at the University Hospital of Basel from November 2020 to approximately December 2024.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • analysis of antimicrobial resistance

    Other intervention

    In samples from patients infected with one of the focus pathogens (E. coli, Klebsiella species, S. aureus, P. aeruginosa) will be: (i) isolated and pathogenic bacteria characterized; (ii) pathogen in-situ properties at single-cell and bulk average determined; (iii) human metabolites, proteins and cells determined (iv) antibiotic concentration determined (v) bacterial growth monitored Deducted from the data will be: 1. relevant human components and pathogen properties that are common to most patients with similar indication 2. underlying regulatory networks and triggers in pathogen cells and human tissues. Clinical outcomes (survival/mortality) and treatment response (response or failure) will be correlated to the in vitro retrieved host and bacterial data.

Treatment groups

8,000 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: A) Urinary tract infection1 intervention
Group B: B) Pneumonia1 intervention
Group C: C) Deep-seated infections1 intervention
Group D: D) Controls for A), B) and C)1 intervention
Group E: E) Clinical controls for A), B) and C) without obtained samples1 intervention
Group F: F) Cohort with analysis whether the application of Article (Art) 34 HFV can avoid a bias1 intervention

Trial outcomes

Primary outcomes

1

Clinical outcome: survival rate

Survival rate (correlated to the in vitro retrieved host and bacterial data. In vitro retrieved host and bacterial data include: Proteomics, Metabolomics, FISH, Histology, PCR/Microbial genome sequencing, Microbial transcriptome, Antibiotic concentration, Timelapse studies, phenotypic characterisations, molecular typing, innate immune response characterization, Antibiotic tolerance testing, Microfluidic systems, 3-D models, Transcriptomics, Flow cytometry (FACS))

Time frame
one time assessment at baseline
2

Clinical outcome: mortality rate

Mortality rate (correlated to the in vitro retrieved host and bacterial data. In vitro retrieved host and bacterial data include: Proteomics, Metabolomics, FISH, Histology, PCR/Microbial genome sequencing, Microbial transcriptome, Antibiotic concentration, Timelapse studies, phenotypic characterisations, molecular typing, innate immune response characterization, Antibiotic tolerance testing, Microfluidic systems, 3-D models, Transcriptomics, Flow cytometry (FACS))

Time frame
one time assessment at baseline
3

Treatment response (binary: yes/ no)

Treatment response (correlated to the in vitro retrieved host and bacterial data. In vitro retrieved host and bacterial data include: Proteomics, Metabolomics, FISH, Histology, PCR/Microbial genome sequencing, Microbial transcriptome, Antibiotic concentration, Timelapse studies, phenotypic characterisations, molecular typing, innate immune response characterization, Antibiotic tolerance testing, Microfluidic systems, 3-D models, Transcriptomics, Flow cytometry (FACS))

Time frame
one time assessment at baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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

University Hospital, Basel, Switzerland

Lead sponsor

Swiss National Science Foundation

Collaborator