Surviving Pneumonia

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.

Study Overview

• Status: Recruiting
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Camilla Ryrsø, MSc; Phone Number: +4548293250; Email: camilla.koch.ryrsoe.01@regionh.dk
• Study Contact Backup: Name: Maria Hegelund, MSc; Phone Number: +4548293250; Email: maria.hein.hegelund.01@regionh.dk

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Recruiting
    • Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital
    • Contact: Birgitte Lindegaard, MD, PhD; Email: birgitte.lindegaard.madsen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Community-acquired pneumonia; Adults over 18 years old admitted with confirmed community-acquired pneumonia.	Other: No intervention; Obervational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Through patient files	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	Through patient files	Up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Self-reported physical activity by scoring of the international physical activity questionnaire (IPAQ)		Day 1
Muscle strength (measured by hand grip test)		Day 1, discharge (an average of 5 days), 1 months and 6 months
Muscle strength (measured by 30-sec chair stand test)		Day 1 and discharge (an average of 5 days)
Functional capacity (measured by 6-minutes walking test)		Day 1 and discharge (an average of 5 days)
Activities of daily living (measured by Barthel100)		Discharge (an average of 5 days)
BMI	Weight (kilograms) and height (cm) will be combined to report BMI in kg/m^2	Day 1, discharge (an average of 5 days), 1 month and 6 months
Waist circumference (measured in cm)		Day 1, discharge (an average of 5 days), 1 month and 6 months
Body composition analysis (measured by DEXA scans)		Day 1, discharge (an average of 5 days), 1 month and 6 months
Body composition analysis (measured by bioimpedance)		Daily during admission, discharge (an average of 5 days), 1 month and 6 months
Nutritional status (measured by NRS2002)		Day 1
Concentration of p-phosphate (mmol/l), p-sodium (mmol/l), p-carbamide (mmol/l), p-potassium (mmol/l)	Blood sampling	Daily during admission, 1 month and 6 months
Concentration of pro- and anti-inflammatory cytokines (IL-6, Il-1ra, IL-18, IL-10, TNF-alpha)		Daily during admission, discharge (an average of 5 days), 1 month and 6 months
Immune cell phenotyping to identify cell counts various T-cells, B-cells, NK-cells and monocytes	Flow cytometry on whole blood	Day 1 and discharge (an average of 5 days)
Concentration of blood lipids	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
Scoring of the Charlson Comorbidity Index to predict 10-year survival	Scale ranges from 0 to 33 points to predict survival (%)	Day 1
Oral status (determined by revised oral assessment guide)		Day 1
Dysphagia screening (eating assessment tool 10)		Day 1
Quality of life (EQ-5D-5L)		Day 1, discharge (an average of 5 days), 1 month and 6 months
Glycemic control during oral glucose tolerance test		Day 1, discharge (an average of 5 days), 1 month and 6 months
Glucagon concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
Insulin concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
C-peptide concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
GLP-1 concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
GLP-2 concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
GIP concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
Insulin sensitivity index (Matsuda) based on oral glucose tolerance test		Day 1, discharge (an average of 5 days), 1 month and 6 months
Insulin secretion index based on oral glucose tolerance test		Day 1, discharge (an average of 5 days), 1 month and 6 months
Concentration of galectin-3 (ng/ml), sST2 (ng/ml), and troponins (ng/ml)	Blood sampling	Daily during admission, 1 month and 6 months
Concentration of NT-proBNP (ng/l)	Blood sampling	Daily during admission, 1 month and 6 months
Z-value of left ventricle (LV) out of echocardiography	Z-value LV	Discharge (an average of 5 days), 1 month and 6 months
Z-value of right ventricle (RV) out of echocardiography	Z-value RV	Discharge (an average of 5 days), 1 month and 6 months
Z-value of left atrium (LA) out of echocardiography	Z-value LA	Discharge (an average of 5 days), 1 month and 6 months
Shortening fraction (SF) measured in echocardiography	SF (%)	Discharge (an average of 5 days), 1 month and 6 months
Ejection fraction (EF) measured in echocardiography	EF (%)	Discharge (an average of 5 days), 1 month and 6 months
Valvular insufficiency measured in echocardiography	Aorta valve regurgitation, pulmonary valve regurgitation, tricuspid valve regurgitation and mitral valve regurgitation (no, minimal, moderate, severe)	Discharge (an average of 5 days), 1 month and 6 months
Heart rate of 12-lead resting ECG	bpm	Daily during admission (up to 5 days)
Rhythm during 12-lead resting ECG	Sinus rhythm yes/no	Daily during admission (up to 5 days)
Axis of the QRS complex out of the 12-lead resting ECG	Degree	Daily during admission (up to 5 days)
Duration of PQ interval out of the 12-lead resting ECG	ms	Daily during admission (up to 5 days)
Duration of the QRS complex out of the 12-lead resting ECG	ms	Daily during admission (up to 5 days)
Number of cardiac events	Assessed through patient files and the national registers	From date of admission up to 24 months
Sputum samples to assess glucose and lactate concentration (measured by ABL)		On admission, 1 month and 6 months
Sputum samples to evaluate drug resistance and O2 content		On admission, 1 month and 6 months
Forced vital capacity (FVC) during spirometry	Litre	Discharge (an average of 5 days)
Forced expiratory volume in 1 second (FEV1) during spirometry	Litre	Discharge (an average of 5 days)
FEV1% predicted during spirometry		Discharge (an average of 5 days)
Chest x-ray to image inflammation of the lungs		On admission, 1 month and 6 months
Early Warning Score (EWS) to identify patients at risk of deterioration in hospital		Daily during admission (up to 5 days)
HbA1c to assess the average blood glucose levels 3 months before admission		Day 1

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Principal Investigator: Birgitte Lindegaard, Assoc. Prof, Nordsjaellands Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2038

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes; Physical inactivity; Risk factors; Nutritional status; Community-acquired pneumonia; Immune status
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: Surviving Pneumonia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No