About this trial
Here, the investigators propose to study host responses to reduced microbiome complexity driven by treatment with broad spectrum antibiotics in patients with severe infections or sepsis. The proposal aims to combine holistic approaches with emerging experimental technologies to investigate the complex interactions between the gut microbiota and its host and assess the impact of specific bacterial communities on longevity and stress responses. A strong focus of this study will also be placed on microbiome dysbiosis and secondary impacts on short- and long-term brain dysfunction using clinical, laboratory and imaging procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
One of the following criteria
Critically ill patients treated with meropenem or piperacillin/tazobactam started within the last 72 h
Critically ill patients without systemic antimicrobial therapy within the last 72 hours and an expected ICU length of stay of more than 3 days
Disqualifiers
Inflammatory bowel disease
Major bowel resection
Selective decontamination of the oral and digestive tract
Oral vancomycin therapy
Trial population
ICU patients with and without antibiotic treatment as well as patients with long-term survival after critical illness
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of patients with brain dysfunction
Patients from all three groups will be assessed for microbiome dysbiosis (e.g. shotgun metagenomics), and for brain dysfunction (e.g. CAM-ICU, ICDSC, MoCa, MMST, neuropsychiatric examination, MRI).
Secondary outcomes
Number of patients with survival
Days on the ICU
Days on the respirator
Days with vasopressor support
Sponsors and contacts
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Jena University Hospital
Lead sponsor
University of Jena
Collaborator