No registrations found.
ID
Source
Brief title
Health condition
Community-acquired pneumonia
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The difference in microbiota reconstitution over different timepoints after
hospitalization for CAP.
Secondary outcome
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
Background summary
Community-acquired pneumonia (CAP) is the most important infection in terms of numbers of patients for which antibiotics are given in the hospital. It is known that after a severe pneumonia and subsequent antibiotic treatment, the gut microbiome is severely perturbed. An association has been described between the extent of this dysbiosis and readmission rates for pneumonia and sepsis.
In recent years we deepened our understanding of the role that the intestinal microbiome plays in the local and systemic immune system. Reconstitution of the severely perturbed microbiome after antibiotic treatment in patients with pneumonia could improve the immune status of patients and thereby ultimately lower readmission and infection rates.
In this pilot study we investigate whether a 90-day treatment with a selected probiotics mixture can reconstitute the gut microbiome diversity after antibiotic treatment for CAP.
Study objective
90-day treatment with a selected probiotics mixture can reconstitute the microbiome diversity after antibiotic treatment for community-acquired pneumonia.
Study design
Within 24 hours after hospital admission for CAP, 2-4 days into the hospital admission, 90 days after hospital discharge.
Intervention
90-day treatment with a selected probiotics mixture or placebo after hospital admission for community-acquired pneumonia.
Inclusion criteria
• 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
Exclusion criteria
• 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8025 |
| CCMO | NL67870.018.18 |
| OMON | NL-OMON49196 |