Community-acquired pneumonia lung infection pneumonia
Conditions
Interventions
After hospitalization and in-hospital antibiotic treatment for CAP, if patients
meet in/exclusion criteria (e.g. no sepsis, no ICU), one group will receive a
probiotic mixture (Ecologic AAD) twice d
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >= 18 y • Clinical suspicion of a new episode of acute respiratory tract infection for which treatment with antibiotics is deemed necessary. • Presence of two or more diagnostic clinical criteria: o Cough o Production of purulent sputum or a change in the character of sputum o Temperature >38°C or 10×10^9 white cells per liter or >15% bands) o C-reactive protein level more than 3 times the upper limit of the normal range o Dyspnoea, tachypnea, or hypoxemia
Exclusion criteria
Exclusion criteria: No informed consent is provided by patient or its legal representative Admission to Intensive Care facilities in the current episode Presence of enterobacteriaceae or staphylococcus aureus bacteraemia Suspicion/diagnosis of aspiration pneumonia More than 7 days use of probiotics or antibiotics within the last 2 months Patients diagnosed with chronic bowel disease and/or colostomy. Patient is enrolled in an interventional clinical study of an anti-infective or immunomodulatory therapy. Pregnancy. Parenteral feeding or enteral tube feeding. Patients who are readmitted to the hospital during the 90-day intervention period will terminate the intervention. Follow-up will be continued without further sampling. Patients who are prescribed new antibiotic treatment by the general practitioner during the 90 day intervention period will terminate the intervention. Follow-up will be continued without further sampling. Patients who are immunocompromised due to active chemotherapy, uncontrolled HIV infection, stem-cell transplantation, haematological malignancies or high-dose immunosuppressive drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Difference in microbiome diversity and composition between groups, analysed by deep 16s RNA sequencing. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events. 2. Difference in mean cytokine response levels between groups. 3. Incidence and duration of antibiotic-associated diarrhoea, based on Bristol-stool scale scores. 4. To link cytokine response levels to microbiome composition and clinical endpoints. | — |
Countries
Netherlands
Outcome results
None listed