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The Effect of Leukocyte DNA mEthylation and micRoBIOME diversity and function on host defense mechanisms during community-acquired pneumonia.

The Effect of Leukocyte DNA mEthylation and micRoBIOME diversity and function on host defense mechanisms during community-acquired pneumonia. - ELDER-BIOME study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50274
Enrollment
843
Registered
2016-09-06
Start date
2016-10-03
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pneumonia

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Age >= 18 y 2) Clinical suspicion of a new episode of acute respiratory tract infection 3) The presence of a new or increased infiltrate on chest radiography or computed tomography (CT) or a positive SARS-CoV-2 PCR on nasopharyngeal swab within 14 days prior to admission 4) Presence of two or more diagnostic clinical criteria: - Cough - Production of purulent sputum or a change in the character of sputum - Temperature >38°C or 10×109 white cells per liter or >15% bands) - C-reactive protein level of more than 3 times the upper limit of the normal range - Dyspnea, tachypnea, or hypoxemia

Exclusion criteria

Exclusion criteria: 1) No informed consent is provided by patient 2) Patients who had recently been hospitalized (for >48 hours in the previous 2 weeks) or who resided in long-term care facilities 3) Patients with a colostomy 4) Patient is enrolled in an interventional clinical study of an anti-infective or immunomodulatory therapy

Design outcomes

Primary

MeasureTime frame
The main parameters of this study will be the alterations in leukocyte DNA methylation and the composition and function of the intestinal and nasopharyngeal microbiota in patients with CAP. These data will be associated with several clinical parameters, including, but not limited to: • Patient demographics and medical history, at enrolment • Date of hospital admission and discharge, transfer or death • Date of high care unit/intensive care unit admission and discharge, transfer or death, if applicable • Clinical outcome: hospital discharge, transfer or in-hospital death • Mortality at day 90

Secondary

MeasureTime frame
Secondary it will be evaluated whether microbiome derived signals are of influence in differences found in methylation in these study groups.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)