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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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ClinicalTrials.gov Identifier: NCT02928367
Recruitment Status : Recruiting
First Posted : October 10, 2016
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
T. van der Poll, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

Community-acquired pneumonia (CAP) represents a major health care problem and mortality and morbidity associated with severe pneumonia remain considerable, despite state of the art care.

While the role of altered DNA methylation in cancer has been widely studied, knowledge of its impact on antibacterial defense is highly limited. In addition, recent preclinical studies showed that the gut and respiratory microbiota contributes to host defense against bacterial pneumonia.

This study aims to explore a completely novel research area linking the extent of DNA methylation in blood leukocyte (monocytes and neutrophils) and function of gut and respiratory microbiota on the influence of innate immune responses to and host defense against CAP


Condition or disease Intervention/treatment
Pneumonia Other: rectal swab Other: nasopharyngeal swab Other: blood draw

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Study Type : Observational
Estimated Enrollment : 231 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Leukocyte Dna mEthylation and micRoBIOME Diversity on Host Defense Mechanisms During Community-acquired Pneumonia
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
Pneumonia patients
rectal swab (4x) divided over two time points (day 0 and day 28) nasopharyngeal swab (2x) divided over two time points (day 0 and day 28) blood draw (90ml) divided over two time points (day 0 and day 28)
Other: rectal swab
rectal swab at baseline visit (2x) and at day 28 (2x) OR rectal swab at single timepoint (2x) (healthy volunteers)

Other: nasopharyngeal swab
nasopharyngeal swab at baseline visit (1x) and at day 28 (1x) OR nasopharyngeal swab at single timepoint (2x) (healthy volunteers)

Other: blood draw
blood draw at baseline visit (45ml) and at day 28 (45ml) (pneumonia patients) OR single blood draw (70ml) (healthy volunteers)

Healthy subjects
rectal swab (2x) nasopharyngeal swab (2x) blood draw (70ml)
Other: rectal swab
rectal swab at baseline visit (2x) and at day 28 (2x) OR rectal swab at single timepoint (2x) (healthy volunteers)

Other: nasopharyngeal swab
nasopharyngeal swab at baseline visit (1x) and at day 28 (1x) OR nasopharyngeal swab at single timepoint (2x) (healthy volunteers)

Other: blood draw
blood draw at baseline visit (45ml) and at day 28 (45ml) (pneumonia patients) OR single blood draw (70ml) (healthy volunteers)




Primary Outcome Measures :
  1. Alterations in leukocyte DNA methylation [ Time Frame: day 0 ]

Secondary Outcome Measures :
  1. Composition and function of the gut and nasopharyngeal microbiota [ Time Frame: day 0 ]
  2. Alterations in leukocyte DNA methylation [ Time Frame: day 28 ]
  3. Composition and function of the gut and nasopharyngeal microbiota [ Time Frame: day 28 ]

Biospecimen Retention:   Samples With DNA
feces, nasofaryngeal swabs, blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults presenting at the Academic Medical Center with a suspected new episode of community acquired pneumonia will be screened for eligibility for the ELDER-BIOME study according to the following scheme:
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928367


Contacts
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Contact: Bastiaan W Haak, MD 5665247 ext 020 b.w.haak@amc.nl
Contact: Xanthe Brands, MD 5665247 ext 020 x.brands@amc.nl

Locations
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Netherlands
Academic Medical Center - University of Amsterdam Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Tom van der Poll, MD, PhD       t.vanderpoll@amc.uva.nl   
Sub-Investigator: W. Joost Wiersinga, MD, PhD, MBA         
Sub-Investigator: Brendon P Scicluna, PhD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Tom van der Poll, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Responsible Party: T. van der Poll, prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02928367    
Other Study ID Numbers: NL57847.018.16
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections