Relation between biomarkers and new radiographic abnormalities in patients hospitalized with Community Acquired Pneumonia

Relation between biomarkers and new radiographic abnormalities in patients hospitalized with Community Acquired Pneumonia - RECAP

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45017

Enrollment

Registered

2015-03-27

Start date

2015-09-01

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male and female patients with a high clinical suspicion of CAP and all criteria listed below: 1. Age 18 or above, no upper age limit will be employed. 2. Clinical presentation of an acute illness with two or more of the following symptoms: a. Temperature * 38.0 *C (100.4°F) b. Dyspnoea c. Cough (with or without expectoration of sputum) d. Chest pain e. Rales, rhonchi or wheezing f. Egophony or bronchial breath sounds 3. No consolidation(s) on the chest radiograph. 4. Written informed consent obtained from the patient or a family member.

Exclusion criteria

Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1. Severe immunosuppression (HIV infection, chemotherapy). 2. Active neoplastic lung disease. 3. Obstruction pneumonia (e.g. from lung cancer). 4. Pneumonia that developed within 8 days after hospital discharge. 5. Unable and/or unlikely to comprehend and/or follow the protocol. 6. Pregnant and/or lactating women.

Design outcomes

Primary

Measure	Time frame
Presence of infiltrates on low-dose CT-scan.	—

Secondary

Measure	Time frame
Secondary efficacy analysis as follows: Mean biomarker levels between groups with a positive CT-scan versus a negative CT-scan. Mean level of biomarker will be assessed by a student T-test if normally distributed or by Mann-Whitney U test if not normally distributed. The amount of abnormalities on CT-scan will be correlated with the levels of biomarkers by a Spearman or Pearson analysis. We will try to determine if there*s a relation between duration of symptoms and the chance of a positive CT-scan. This will be done by a binary logistic regression for the outcome yes/no. And by linear regression for duration of symptoms versus the amount of abnormalities on CT-scan.	—

Measure

Time frame

Secondary efficacy analysis as follows: Mean biomarker levels between groups with a positive CT-scan versus a negative CT-scan. Mean level of biomarker will be assessed by a student T-test if normally distributed or by Mann-Whitney U test if not normally distributed. The amount of abnormalities on CT-scan will be correlated with the levels of biomarkers by a Spearman or Pearson analysis. We will try to determine if there*s a relation between duration of symptoms and the chance of a positive CT-scan. This will be done by a binary logistic regression for the outcome yes/no. And by linear regression for duration of symptoms versus the amount of abnormalities on CT-scan.

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Countries

Netherlands

Outcome results