Diagnostic intervention study of low-dose CT and multiplex PCR on antibiotic treatment and outcome of community-acquired pneumonia

Completed

• Conditions: pneumonia; pulmonary infection; 10019815; 10024970

• Registration Number: NL-OMON48670
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3760

Inclusion Criteria

- Being aged 18 years or above;
- Having a working diagnosis of CAP at the emergency department with the
presence of at least two of the clinical criteria (below)* or one clinical
criterion and radiological evidence of CAP, with no other explanation for the
signs and symptoms;
- Requiring hospitalisation to a non-ICU ward via the ER., * Clinical criteria
include:
* New or worsened coughing;
* Production of purulent sputum or change in character of sputum;
* Temperature > 38°C or <<= 36.0°C;
* Auscultatory findings consistent with pneumonia, including rales, evidence of
pulmonary consolidation (dullness on percussion, bronchial breath sounds, or
egophony), or both;
* White blood cell count of >10×10^9 cells/L or <4x10^9 cells/L or >15% bands
* C-reactive protein level ><= 30 mg/L;
* Dyspnea, tachypnea (> 20 breaths per minute), or hypoxaemia (arterial pO2 <60
mmHg or peripheral O2 saturation < 90%).

Exclusion Criteria

- Hospitalisation for two or more days in the last 14 days;
- Residence in a long-term care facility in the last 14 days;
- History of cystic fibrosis;
- Severe immunodeficiency, defined as having one or more of the following
criteria:
* HIV infection with a last CD4 count of <300/*L;
* Cytotoxic chemotherapy or radiotherapy in the previous 3 months;
* Chronic hemodialysis > 3 months;
* History of receiving an organ or bone marrow transplant;
* Using immunosuppressive therapy. This includes corticosteroid treatment only
when dosage is high (>0,5mg/kg/day) for a longer period of time (>14 days).
* History of primary immunocompromising conditions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary effectiveness outcome is days of therapy of broad-spectrum<br /><br>antibiotics. The primary safety outcome, on which the sample size is<br /><br>calculated, is 90-day all-cause mortality.</p><br>