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RecruitingNCT03795662Updated Apr 29, 2021

Surviving Pneumonia

An observational study in Community-acquired Pneumonia, sponsored by Nordsjaellands Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-29.

Sponsored by Nordsjaellands Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2019; still recruiting 7 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Community-acquired Pneumonia

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Keywords

  • Community-acquired pneumonia
  • Diabetes
  • Immune status
  • Nutritional status
  • Physical inactivity
  • Risk factors
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Nordsjaellands Hospital is the lead sponsor of 88 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients unable to give informed consent
  • Patients unwilling to give informed consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Community-acquired pneumonia

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

    Other: No intervention

Interventions

  • OtherNo intervention

    Obervational

06

What researchers measure

Primary outcomes

  1. Number of death from any causes

    Assessed through patient files

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

  2. Number of participants who develop diabetes

    Assessed through patient files and the national registers

    Time frame: Up to 24 months

Secondary outcomes

  1. Length of hospital stay

    Through patient files

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

  2. Oral glucose tolerance test

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

  3. Number of participants who are readmitted

    Through patient files

    Time frame: Up to 6 months

Other outcomes

  1. Facal sample to assess changes in microbiome

    Time frame: Day 1, 1 month and 6 months

  2. Urine samples to assess metabolomics

    Time frame: Day 1, 1 month and 6 months

  3. Physical activity monitoring (measured by the AX3 accelerometers)

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

  4. Self-reported physical activity by scoring of the international physical activity questionnaire (IPAQ)

    Time frame: Day 1

  5. Muscle strength (measured by hand grip test)

    Time frame: Day 1, discharge (an average of 5 days), 1 months and 6 months

  6. Muscle strength (measured by 30-sec chair stand test)

    Time frame: Day 1 and discharge (an average of 5 days)

  7. Functional capacity (measured by 6-minutes walking test)

    Time frame: Day 1 and discharge (an average of 5 days)

  8. Activities of daily living (measured by Barthel100)

    Time frame: Discharge (an average of 5 days)

  9. BMI

    Weight (kilograms) and height (cm) will be combined to report BMI in kg/m\^2

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  10. Waist circumference (measured in cm)

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  11. Body composition analysis (measured by DEXA scans)

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  12. Body composition analysis (measured by bioimpedance)

    Time frame: Daily during admission, discharge (an average of 5 days), 1 month and 6 months

  13. Nutritional status (measured by NRS2002)

    Time frame: Day 1

  14. Concentration of p-phosphate (mmol/l), p-sodium (mmol/l), p-carbamide (mmol/l), p-potassium (mmol/l)

    Blood sampling

    Time frame: Daily during admission, 1 month and 6 months

  15. Concentration of pro- and anti-inflammatory cytokines (IL-6, Il-1ra, IL-18, IL-10, TNF-alpha)

    Time frame: Daily during admission, discharge (an average of 5 days), 1 month and 6 months

  16. Immune cell phenotyping to identify cell counts various T-cells, B-cells, NK-cells and monocytes

    Flow cytometry on whole blood

    Time frame: Day 1 and discharge (an average of 5 days)

  17. Concentration of blood lipids

    Blood sampling

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  18. Scoring of the Charlson Comorbidity Index to predict 10-year survival

    Scale ranges from 0 to 33 points to predict survival (%)

    Time frame: Day 1

  19. Oral status (determined by revised oral assessment guide)

    Time frame: Day 1

  20. Dysphagia screening (eating assessment tool 10)

    Time frame: Day 1

  21. Quality of life (EQ-5D-5L)

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  22. Glycemic control during oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  23. Glucagon concentration during oral glucose tolerance test

    Blood sampling

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  24. Insulin concentration during oral glucose tolerance test

    Blood sampling

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  25. C-peptide concentration during oral glucose tolerance test

    Blood sampling

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  26. GLP-1 concentration during oral glucose tolerance test

    Blood sampling

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  27. GLP-2 concentration during oral glucose tolerance test

    Blood sampling

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  28. GIP concentration during oral glucose tolerance test

    Blood sampling

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  29. Insulin sensitivity index (Matsuda) based on oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  30. Insulin secretion index based on oral glucose tolerance test

    Time frame: Day 1, discharge (an average of 5 days), 1 month and 6 months

  31. Concentration of galectin-3 (ng/ml), sST2 (ng/ml), and troponins (ng/ml)

    Blood sampling

    Time frame: Daily during admission, 1 month and 6 months

  32. Concentration of NT-proBNP (ng/l)

    Blood sampling

    Time frame: Daily during admission, 1 month and 6 months

  33. Z-value of left ventricle (LV) out of echocardiography

    Z-value LV

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

  34. Z-value of right ventricle (RV) out of echocardiography

    Z-value RV

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

  35. Z-value of left atrium (LA) out of echocardiography

    Z-value LA

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

  36. Shortening fraction (SF) measured in echocardiography

    SF (%)

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

  37. Ejection fraction (EF) measured in echocardiography

    EF (%)

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

  38. Valvular insufficiency measured in echocardiography

    Aorta valve regurgitation, pulmonary valve regurgitation, tricuspid valve regurgitation and mitral valve regurgitation (no, minimal, moderate, severe)

    Time frame: Discharge (an average of 5 days), 1 month and 6 months

  39. Heart rate of 12-lead resting ECG

    bpm

    Time frame: Daily during admission (up to 5 days)

  40. Rhythm during 12-lead resting ECG

    Sinus rhythm yes/no

    Time frame: Daily during admission (up to 5 days)

  41. Axis of the QRS complex out of the 12-lead resting ECG

    Degree

    Time frame: Daily during admission (up to 5 days)

  42. Duration of PQ interval out of the 12-lead resting ECG

    ms

    Time frame: Daily during admission (up to 5 days)

  43. Duration of the QRS complex out of the 12-lead resting ECG

    ms

    Time frame: Daily during admission (up to 5 days)

  44. Number of cardiac events

    Assessed through patient files and the national registers

    Time frame: From date of admission up to 24 months

  45. Sputum samples to assess glucose and lactate concentration (measured by ABL)

    Time frame: On admission, 1 month and 6 months

  46. Sputum samples to evaluate drug resistance and O2 content

    Time frame: On admission, 1 month and 6 months

  47. Forced vital capacity (FVC) during spirometry

    Litre

    Time frame: Discharge (an average of 5 days)

  48. Forced expiratory volume in 1 second (FEV1) during spirometry

    Litre

    Time frame: Discharge (an average of 5 days)

  49. FEV1% predicted during spirometry

    Time frame: Discharge (an average of 5 days)

  50. Chest x-ray to image inflammation of the lungs

    Time frame: On admission, 1 month and 6 months

  51. Early Warning Score (EWS) to identify patients at risk of deterioration in hospital

    Time frame: Daily during admission (up to 5 days)

  52. HbA1c to assess the average blood glucose levels 3 months before admission

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
  • Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
    Hillerød, 3400, Denmark
    Recruiting
08

References and documents

Publications

  • 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. PubMed 36362554 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03795662
Lead sponsor
Nordsjaellands Hospital
Responsible party
Birgitte Lindegaard Madsen (Associated professor, MD, PhD, Nordsjaellands Hospital) — Principal investigator
First posted
Jan 8, 2019
Start date
Jan 7, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2038 (estimated)
Last update
Apr 29, 2021

Study contacts

Camilla Ryrsø, MSc
Contact
camilla.koch.ryrsoe.01@regionh.dk
+4548293250
Maria Hegelund, MSc
Contact
maria.hein.hegelund.01@regionh.dk
+4548293250
Birgitte Lindegaard, Assoc. Prof
principal investigator · Nordsjaellands Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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