DiagNostic Study of Low-dose CT and multipleX PCR on Antibiotic Treatment and Outcome of Community-Acquired Pneumonia

Community-acquired Pneumonia Clinical Trial

— CAP-NEXT  

Official title:

DiagNostic Intervention Study of Low-dose CT and multipleX PCR on Antibiotic Treatment and Outcome of Community-Acquired Pneumonia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03360851
• Other study ID #: NL61857.041.17
• Status: Terminated
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2021
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rationale:

Uncertainty in the clinical and etiological diagnosis of community-acquired pneumonia (CAP) often leads to incorrect treatment and unnecessary use of broad-spectrum antibiotics. Establishing the clinical diagnosis of CAP is hampered by the suboptimal sensitivity of chest radiograph to detect pulmonary infiltrates (~70%). Establishing the etiological diagnosis is also hampered, mainly because of the inevitable diagnostic delays and low sensitivity of routine microbiological tests. There are currently no recommendations for low-dose chest computed tomography (low-dose CT) or viral and bacterial point-of-care multiplex polymerase chain reaction (PoC-PCR) in the diagnostic work-up of CAP patients, because the data supporting such an approach are lacking.

Objective: The aim of this study is to determine the added value of low-dose CT and PoC-PCR in the diagnostic workup of patients with CAP hospitalised to non-intensive care unit (ICU) wards in minimizing selective antibiotic pressure while maintaining patient safety.

Study design: Cluster-randomised controlled trial with historical control period.

Study population: Adult patients (>=18 years old) with a clinical diagnosis of CAP requiring hospitalisation to a non-ICU ward.

Intervention: 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.

Main study parameters/endpoints: 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.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks associated with performing the PoC-PCR and the radiation of the low-dose CT is of negligible risk. Nasopharyngeal swab collection causes a temporary unpleasant sensation. The low-dose CT can reveal unexpected findings which may require additional diagnostic procedures, for which the treating physician will use state-of-the-art guidelines. Treatment recommendations to de-escalate or stop antibiotic treatment may be beneficial for the individual patient by minimising exposure to antibiotics and improve targeted use of antibiotics. Final decisions are always made by the treating physician taking into account all clinical information.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3555
• Est. completion date: March 1, 2021
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged 18 years or above;

• working diagnosis of CAP at the emergency department with the presence of at least two clinical criteria 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.

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

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Diagnostic Test:
• low-dose CT
see arm/group description
• PoC-PCR
see arm/group description

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Ter Gooi Ziekenhuis	Hilversum
Netherlands	University Medical Center	Utrecht
Netherlands	Maxima MC	Veldhoven
Netherlands	Langeland Ziekenhuis	Zoetermeer

Sponsors (2)

Lead Sponsor	Collaborator
MJM Bonten	BioMérieux

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of therapy of broad-spectrum antibiotics	Days of treatment with broad-spectrum antibiotics during index admission. This will include antibiotic prescriptions provided at discharge.	throughout hospitalization, an average of 7 days
Primary	All-cause mortality	All-cause mortality within 90 days of admission.	90 days
Secondary	days of therapy with any antibiotic	Number of days of treatment with any antibiotics during index admission, including antibiotic prescriptions provided at discharge.	throughout hospitalization, an average of 7 days
Secondary	all-cause mortality		30 days
Secondary	length of hospital stay		throughout hospitalization, an average of 7 days
Secondary	adverse outcomes	Composite endpoint comprising ICU admission, in-hospital mortality, and readmission	90 days
Secondary	time to results	Time from admission to availability of the low-dose CT / PoC-PCR results.	throughout hospitalization, an average of 7 days
Secondary	time to treatment recommendations	Time from admission to provision of a treatment recommendation following the low-dose CT / PoC-PCR results.	throughout hospitalization, an average of 7 days
Secondary	change in antibiotic consumption	Whether changes were made in the antibiotic class during treatment	throughout hospitalization, an average of 7 days
Secondary	time to change in antibiotic consumption	When changes were made in the antibiotic class during treatment	throughout hospitalization, an average of 7 days