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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48670
Enrollment
3760
Registered
2019-11-29
Start date
2017-12-05
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pneumonia

Interventions

Intervention arm 1: availability of PoC-PCR during the ER visit
intervention arm 2: performing low-dose CT from the ER or at least within 24 hours
control arm: standard care.
Antibiotics
Pneumonia

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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 10×10^9 cells/L or 15% bands * C-reactive protein level > 20 breaths per minute), or hypoxaemia (arterial pO2

Exclusion criteria

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 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

Design outcomes

Primary

MeasureTime frame
The primary effectiveness outcome is days of therapy of broad-spectrum antibiotics. The primary safety outcome, on which the sample size is calculated, is 90-day all-cause mortality.

Secondary

MeasureTime frame
- Number of days of treatment with any antibiotics during index admission, including antibiotic prescriptions provided at discharge; - Number of days hospitalized during the index hospitalization; - Occurrence of ICU admission during the index hospitalization; - Occurrence of in-hospital mortality during the index hospitalization; - Occurrence of readmissions after the index admission within 30 days of the index admission; - Time from admission to availability of the low-dose CT results; - Time from admission to provision of a treatment recommendation following the low-dose CT results; - Proportion of patients changing the diagnosis based on low-dose CT results; - Time from admission to change in diagnosis based on low-dose CT results; - Time from presenting at the ER to availability of the PoC-PCR test results; - Time from presenting at the ER to provision of a treatment recommendation following the PoC-PCR test results; - Proportion of patients changing from empirical to or started on targeted antibiotic treatment based on PoC-PCR results; - Proportion of patients stopping empirical antibiotic treatment early (within 72 hours) based on PoC-PCR results; - Time from admission to targeted antibiotic treatment or early termination based on the PoC-PCR results;

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)