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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02928367 |
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Date of registration:
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06/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Leukocyte Dna mEthylation and micRoBIOME Diversity on Host Defense Mechanisms During Community-acquired Pneumonia (ELDER-BIOME)
ELDER-BIOME |
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Scientific title:
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The Effect of Leukocyte Dna mEthylation and micRoBIOME Diversity on Host Defense Mechanisms During Community-acquired Pneumonia |
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Date of first enrolment:
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October 1, 2016 |
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Target sample size:
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231 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02928367 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Tom van der Poll, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
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Name:
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Tom van der Poll, MD, PhD |
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Address:
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Telephone:
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Email:
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t.vanderpoll@amc.uva.nl |
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Affiliation:
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Name:
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Bastiaan W Haak, MD |
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Address:
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Telephone:
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5665247 |
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Email:
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b.w.haak@amc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical suspicion of a new episode of acute respiratory tract infection
- Primary reason for presentation is clinical suspicion of a new episode of acute
respiratory infection; admission to the hospital is NOT a requirement
- Evident new or progressive infiltrate, consolidation, cavitation, or pleural effusion
on the chest X ray or CT scan made for diagnostic (non-research) purposes
- Onset of the following symptoms within the last 7 days:
- At least one respiratory symptom (cough, sore throat, runny or congested nose,
dyspnea)
- At least one systemic symptom (fever, headache, muscle ache, sweats or chills or
tiredness).
Exclusion Criteria:
- Patient lacks capacity to provide informed consent
- No informed consent is provided by patient
- Patient has been transferred from another hospital
- Patient is enrolled in an interventional clinical study of an anti-infective or
immunomodulatory therapy
- Patient has received any type of oral or systemic antibiotics for more than 48 hours
prior to hospital presentation.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pneumonia
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Intervention(s)
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Other: rectal swab
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Other: nasopharyngeal swab
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Other: blood draw
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Primary Outcome(s)
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Alterations in leukocyte DNA methylation
[Time Frame: day 0]
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Secondary Outcome(s)
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Composition and function of the gut and nasopharyngeal microbiota
[Time Frame: day 0]
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Composition and function of the gut and nasopharyngeal microbiota
[Time Frame: day 28]
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Alterations in leukocyte DNA methylation
[Time Frame: day 28]
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Secondary ID(s)
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NL57847.018.16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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