Surviving Pneumonia

Community-acquired Pneumonia Clinical Trial

Official title:

Surviving Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03795662
• Other study ID #: Surviving Pneumonia
• Status: Recruiting
• Start date: January 7, 2019
• Est. completion date: December 31, 2038

Study information

• Verified date: April 2021
• Source: Nordsjaellands Hospital
• Contact: Camilla Ryrsø, MSc
• Phone: +4548293250
• Email: camilla.koch.ryrsoe.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Other:
• No intervention
Obervational

Locations

Country	Name	City	State
Denmark	Department of Pulmonary and Infectious Diseases, Nordsjællands Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Facal sample to assess changes in microbiome		Day 1, 1 month and 6 months
Other	Urine samples to assess metabolomics		Day 1, 1 month and 6 months
Other	Physical activity monitoring (measured by the AX3 accelerometers)		During admission (up to 7 days), 14 days from discharge (an average of 5 days)
Other	Self-reported physical activity by scoring of the international physical activity questionnaire (IPAQ)		Day 1
Other	Muscle strength (measured by hand grip test)		Day 1, discharge (an average of 5 days), 1 months and 6 months
Other	Muscle strength (measured by 30-sec chair stand test)		Day 1 and discharge (an average of 5 days)
Other	Functional capacity (measured by 6-minutes walking test)		Day 1 and discharge (an average of 5 days)
Other	Activities of daily living (measured by Barthel100)		Discharge (an average of 5 days)
Other	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
Other	Waist circumference (measured in cm)		Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	Body composition analysis (measured by DEXA scans)		Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	Body composition analysis (measured by bioimpedance)		Daily during admission, discharge (an average of 5 days), 1 month and 6 months
Other	Nutritional status (measured by NRS2002)		Day 1
Other	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
Other	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
Other	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)
Other	Concentration of blood lipids	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	Scoring of the Charlson Comorbidity Index to predict 10-year survival	Scale ranges from 0 to 33 points to predict survival (%)	Day 1
Other	Oral status (determined by revised oral assessment guide)		Day 1
Other	Dysphagia screening (eating assessment tool 10)		Day 1
Other	Quality of life (EQ-5D-5L)		Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	Glycemic control during oral glucose tolerance test		Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	Glucagon concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	Insulin concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	C-peptide concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	GLP-1 concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	GLP-2 concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	GIP concentration during oral glucose tolerance test	Blood sampling	Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	Insulin sensitivity index (Matsuda) based on oral glucose tolerance test		Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	Insulin secretion index based on oral glucose tolerance test		Day 1, discharge (an average of 5 days), 1 month and 6 months
Other	Concentration of galectin-3 (ng/ml), sST2 (ng/ml), and troponins (ng/ml)	Blood sampling	Daily during admission, 1 month and 6 months
Other	Concentration of NT-proBNP (ng/l)	Blood sampling	Daily during admission, 1 month and 6 months
Other	Z-value of left ventricle (LV) out of echocardiography	Z-value LV	Discharge (an average of 5 days), 1 month and 6 months
Other	Z-value of right ventricle (RV) out of echocardiography	Z-value RV	Discharge (an average of 5 days), 1 month and 6 months
Other	Z-value of left atrium (LA) out of echocardiography	Z-value LA	Discharge (an average of 5 days), 1 month and 6 months
Other	Shortening fraction (SF) measured in echocardiography	SF (%)	Discharge (an average of 5 days), 1 month and 6 months
Other	Ejection fraction (EF) measured in echocardiography	EF (%)	Discharge (an average of 5 days), 1 month and 6 months
Other	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
Other	Heart rate of 12-lead resting ECG	bpm	Daily during admission (up to 5 days)
Other	Rhythm during 12-lead resting ECG	Sinus rhythm yes/no	Daily during admission (up to 5 days)
Other	Axis of the QRS complex out of the 12-lead resting ECG	Degree	Daily during admission (up to 5 days)
Other	Duration of PQ interval out of the 12-lead resting ECG	ms	Daily during admission (up to 5 days)
Other	Duration of the QRS complex out of the 12-lead resting ECG	ms	Daily during admission (up to 5 days)
Other	Number of cardiac events	Assessed through patient files and the national registers	From date of admission up to 24 months
Other	Sputum samples to assess glucose and lactate concentration (measured by ABL)		On admission, 1 month and 6 months
Other	Sputum samples to evaluate drug resistance and O2 content		On admission, 1 month and 6 months
Other	Forced vital capacity (FVC) during spirometry	Litre	Discharge (an average of 5 days)
Other	Forced expiratory volume in 1 second (FEV1) during spirometry	Litre	Discharge (an average of 5 days)
Other	FEV1% predicted during spirometry		Discharge (an average of 5 days)
Other	Chest x-ray to image inflammation of the lungs		On admission, 1 month and 6 months
Other	Early Warning Score (EWS) to identify patients at risk of deterioration in hospital		Daily during admission (up to 5 days)
Other	HbA1c to assess the average blood glucose levels 3 months before admission		Day 1
Primary	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
Primary	Number of participants who develop diabetes	Assessed through patient files and the national registers	Up to 24 months
Secondary	Length of hospital stay	Through patient files	Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary	Oral glucose tolerance test		Day 1, discharge (an average of 5 days), 1 month and 6-month
Secondary	Number of participants who are readmitted	Through patient files	Up to 6 months