Reconstituting the microbiome after pneumonia
- Conditions
- Community-acquired pneumonia
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 80
• Age = 18 y
• Clinical suspicion of a new episode of acute lower respiratory tract infection
for which treatment with antibiotics is deemed necessary.
• Primary reason for presentation is clinical suspicion of a new episode of
acute lower respiratory infection.
• The presence of a new infiltrate on chest radiography or
computed tomography (CT).
• Presence of two or more diagnostic clinical criteria
o Cough
o Production of purulent sputum or a change in the type of sputum
o Temperature >38°C or <36.1°C
o Auscultatory findings consistent with pneumonia, including rales,
evidence of pulmonary consolidation (dullness on
o percussion, bronchial breath sounds, or egophony), or both
o Leukocytosis (>10×109 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
• No informed consent is provided by patient or its legal representative.
• Admission to Intensive Care facilities in the current hospital 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.
• Pregnancy.
• Parenteral or enteral tube feeding.
• Patient is enrolled in an interventional clinical study of an anti-infective or
immunomodulatory therapy.
• Patients who are readmitted to the hospital during the 90-day intervention period will
terminate the intervention.
• Patients who are prescribed new antibiotic treatment by the general practitioner during
the 90 day intervention period will terminate the intervention.
• Patients who are immunocompromised due to active chemotherapy, uncontrolled HIV infection, stem-cell transplantation, haematological malignancies or high-dose immunosuppressive drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The difference in microbiota reconstitution over different timepoints after<br>hospitalization for CAP.
- Secondary Outcome Measures
Name Time Method 1. Incidence of adverse events.<br>2. Difference in mean cytokine response levels between groups.<br>3. Incidence and duration of antibiotic-associated diarrhoea, based on Bristol-stool<br>scale scores.<br>4. To link cytokine response levels to microbiome composition and clinical endpoints