NCT03795662

Brief Summary

The study aims to explore risk factors for poor prognosis among patients admitted with community-acquired pneumonia (CAP). During a 5-year study period, all patients (aged ≥ 18 years) admitted with CAP at North Zealand Hospital will be invited for inclusion. Questionnaires, anthropometric measures, laboratory tests, and biomaterials will be collected at admission, daily during admission, at discharge and at follow-up. The main clinical outcomes of the study consist of deaths and development of diabetes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
151mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jan 2019Dec 2038

First Submitted

Initial submission to the registry

November 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2038

Expected
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

5 years

First QC Date

November 9, 2018

Last Update Submit

April 28, 2021

Conditions

Community-acquired Pneumonia

Keywords

Community-acquired pneumoniaDiabetesImmune statusNutritional statusPhysical inactivityRisk factors

Outcome Measures

Primary Outcomes (2)

  • Number of death from any causes

    Assessed through patient files

    From date of admission until the day of death from any causes, up to 24 months

  • Number of participants who develop diabetes

    Assessed through patient files and the national registers

    Up to 24 months

Secondary Outcomes (3)

  • Length of hospital stay

    Participants will be followed for the duration of hospital stay, an expected average of 5 days

  • Oral glucose tolerance test

    Day 1, discharge (an average of 5 days), 1 month and 6-month

  • Number of participants who are readmitted

    Up to 6 months

Other Outcomes (52)

  • Facal sample to assess changes in microbiome

    Day 1, 1 month and 6 months

  • Urine samples to assess metabolomics

    Day 1, 1 month and 6 months

  • Physical activity monitoring (measured by the AX3 accelerometers)

    During admission (up to 7 days), 14 days from discharge (an average of 5 days)

  • +49 more other outcomes

Study Arms (1)

Community-acquired pneumonia

Adults over 18 years old admitted with confirmed community-acquired pneumonia.

Other: No intervention

Interventions

No interventionOTHER

Obervational

Community-acquired pneumonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (≥18 years) admitted with community-acquired pneumonia

You may qualify if:

  • Infiltrate on chest radiograph plus one or more of the following:
  • Fever (temperature, ≥38.0°C)
  • Hypothermia (\<35.0°C),
  • New cough with or without sputum production
  • Pleuritic chest pain
  • Dyspnea
  • Altered breath sounds on auscultation.

You may not qualify if:

  • Patients unable to give informed consent
  • Patients unwilling to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital

Hillerød, 3400, Denmark

RECRUITING

Related Publications (1)

  • Ryrso CK, Hegelund MH, Dungu AM, Faurholt-Jepsen D, Pedersen BK, Ritz C, Krogh-Madsen R, Lindegaard B. Association between Barthel Index, Grip Strength, and Physical Activity Level at Admission and Prognosis in Community-Acquired Pneumonia: A Prospective Cohort Study. J Clin Med. 2022 Oct 27;11(21):6326. doi: 10.3390/jcm11216326.

    PMID: 36362554DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples Urine samples Fecal samples Airway samples

MeSH Terms

Conditions

Community-Acquired PneumoniaDiabetes MellitusSedentary Behavior

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Birgitte Lindegaard, Assoc. Prof

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Ryrsø, MSc

CONTACT

+4548293250camilla.koch.ryrsoe.01@regionh.dk

Maria Hegelund, MSc

CONTACT

+4548293250maria.hein.hegelund.01@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor, MD, PhD

Study Record Dates

First Submitted

November 9, 2018

First Posted

January 8, 2019

Study Start

January 7, 2019

Primary Completion

December 31, 2023

Study Completion (Estimated)

December 31, 2038

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)