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The Effect of a Point-of-care Sputum Specimen Assay at the Emergency Department for Patients Suspected of Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04651712
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : November 29, 2021
Information provided by (Responsible Party):
University of Southern Denmark

Brief Summary:

Antibiotic resistance has been identified by the WHO as one of the biggest threats to the health of the world population. In Denmark, there has been an increasing focus on optimizing antibiotic consumption in recent years, but despite significant efforts, total consumption has increased in the hospital sector, especially regarding consumption and in the use of broad-spectrum antibiotics. Currently, a pneumonia diagnosis is primarily based on clinical symptoms such as cough, shortness of breath, chest pain, fever and sputum production, combined with X-ray of the lungs, relevant blood tests and microbiological analysis of sputum samples. X-ray is however an imprecise diagnostic tool, and sputum assays responses are available after 2 days. Sputum can be cultivated to determine the bacterial agent. However, the sputum samples are often of poor quality and many patients cannot deliver a sample. A recently published Danish study shows, that only half of the patients at the ED have sputum samples collected for culturing and none of them had the antibiotic treatment adjusted based on the microbiological results of the sputum.

This study's hypothesis is that point-of-care-polymerase chain reaction (POC-PCR) is superior to standard care on the prescription of targeted pneumonia treatment.

Condition or disease Intervention/treatment Phase
Pneumonia, Bacterial Diagnostic Test: POC-PCR Not Applicable

Detailed Description:

The diagnosis of pneumonia is challenged by nonspecific symptoms, uncertain diagnostic methods, poor prognostic tools and waiting time for test results up to several days. A patient's length of stay in a Danish Emergency Department rarely exceeds 48 hours. Within this period the patient is examined, treated and discharged either home or to another department. Therefore, rapid molecular detection of respiratory pathogens is needed to add value to the management of the diagnostics of pneumonia and could reduce the initial use of antibiotics. Molecular diagnostic tests based on polymerase chain reaction (PCR) assays generate high sensitive analyses in one hour from specimen collection. The Biofire® FilmArray® Pneumonia Panel plus (Biomérieux) can identify 18 bacterial agents including 3 atypical pathogens 9 viruses and 7 antimicrobial resistance genes. This point-of-care (POC) test is promising, as bacterial pathogens often coexist with viruses or are identified with mixed infections. However, the high specificity of molecular diagnostics can challenge the interpretation of clinically significant agents and demands interpretation by highly qualified specialists. Therefore, the POC-PCR combined with advice from a microbiologist has the potential to optimize therapeutic regimens and reduce prescriptions of inappropriate broad-spectrum antibiotics in the initial management of pneumonia.

This study aims to

  • investigate how effective the addition of POC-PCR analysis of sputum is to the diagnostic set-up for community-acquired pneumonia on antibiotic prescription at 4 hours after admission without consequent adverse advents
  • to identify the effect of POC-PCR on prescribed antibiotic treatment 48 hours after admission and 24 hours after discharge
  • to investigate the agreement between POC-PCR and sputum culture on microbiological analysis

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The patients will be blinded, and the investigator will be blinded to POC-PCR results, data management and analysis, but not allocation. Outcome assessors will not be blinded
Primary Purpose: Treatment
Official Title: The Effect of a Point-of-care Sputum Specimen Assay on Antibiotic Treatment of Patients Admitted Acutely With Suspected Pneumonia: A Multicenter Randomized Controlled Trial
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Standard care
A treating physician must perform a clinical assessment within half an hour of patient arrival. This assessment includes the decision whether the patient is suspected of having pneumonia and if this is the case, a sputum specimen and chest x-ray will be ordered. Patients with suspected pneumonia who can deliver a sputum specimen will be randomly allocated with a 1:1 computer-generated randomization schedule with permuting blocks in relation to optimal therapeutical intervention strategy. All standard care sputum samples will be cultured and analysed according to the sites' standard procedures. Under standard care, the treating physician alone decides on the optimal therapeutical intervention.
Active Comparator: POC-PCR analysis supplied with a recommended action list developed by a microbiologist
Along with standard analyses, the specimens will be analysed with POC-PCR and the treating physician will receive an action-list with the results from POC-PCR.
Diagnostic Test: POC-PCR
The result of the POC-PCR will be presented by the study assistant to the treating physician within four hours upon admission. The treating physician will along with the result receive a recommended action list, developed by microbiologists.

Primary Outcome Measures :
  1. Antibiotic treatment at 4-hour plan [ Time Frame: 4 hours after admission ]
    The primary outcome is to determine the effectiveness of POC-PCR sputum analysis on antibiotic prescription, the treatment will either be registered as targeted or non-targeted antibiotic treatment at four hours after admission. This is a binary outcome.

Secondary Outcome Measures :
  1. Intensive care unit (ICU) treatment [ Time Frame: within 60 days from admission to the emergency department ]
    Transfer to the intensive care unit will be recorded during the current hospitalization as a binary variable (transferred/not-transferred)

  2. Length of hospital stay [ Time Frame: within 60 days from current admission to the emergency department ]
    Defined as the time (in days) spent in hospital during the current admission. Measured in days from admission to hospital discharge. Discharge date minus admission date.

  3. 30-days mortality [ Time Frame: 30 days from the admission to the emergency department ]
    Mortality within 30 days from admission to the Emergency Department

  4. Readmission [ Time Frame: within 30 days from the discharge to the hospital ]
    If a subject is admitted over a 30 day period after the current hospitalization discharge measured as a binary outcome Re-admissions/not re-admissions.

  5. In-hospital mortality [ Time Frame: within 60 days from admission to the emergency department ]
    Patient mortality during the current hospitalization. Binary outcome - Died/ Not died

  6. Antibiotic treatment at 48 hour [ Time Frame: 48 hours after admission ]
    The treatment will either be registered as targeted or non-targeted antibiotic treatment 48 hours after admission. This is a binary outcome.

  7. Antibiotic treatment at discharge from hospital [ Time Frame: 24 hours after hospital discharge ]
    The treatment will either be registered as a targeted or non-targeted antibiotic treatment after the patient is discharged from the hospital. This is a binary outcome.

  8. Bacterial agents and viruses from the microbiological results [ Time Frame: Within the first 7 days from specimen collection ]
    The bacterial agents and viruses from the Biofire® FilmArray® Pneumonia Panel plus (Biomérieux) and standard sputum culture for the two microbiological analysis will be presented as descriptive statistics.

Other Outcome Measures:
  1. CURB-65 score for pneumonia severity [ Time Frame: within 4 hours from admission ]
    Confusion of new onset, Blood Urea nitrogen greater than 7 mmol/L (19 mg/dL), respiratory rate of 30 breaths per minute or greater, blood pressure less than 90 mmHg systolic or diastolic blood pressure 60 mmHg or less and age 65 or older

  2. Pneumonia severity index (PSI) [ Time Frame: within 4 hours from admission ]
    Risk classes to predict the severity of pneumonia. Scores are given based on demographics, comorbidity, clinical measurements and physical Exam Findings (<70 = Risk Class II, 71-90 = Risk Class III, 91-130 = Risk Class IV, >130 = Risk Class V)

  3. Number of clostridium infections [ Time Frame: measured 40 days after discharge from the emergency department ]
    Identify through patient records if the patient was infected with clostridium difficille, binary outcome yes/no

  4. Procalcitonin (PCT), Soluble Urokinase Plasminogen Activator Receptor (suPAR), YKL-40 and Krebs von den Lungen (KL-6) [ Time Frame: results within 4 hour from admission ]
    Measurement of serum PCT and suPAR are collected in connection to routine blood tests within 1 hour from admission

  5. 90 days mortality [ Time Frame: Within 90 days from admission to emergency department ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Emergency department patients suspected of pneumonia by the attending physician and with at least one of the following symptoms: dyspnea, cough, expectoration, chest tightness or fever and indication for chest x-ray

Exclusion Criteria:

  • If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
  • Admission within the last 14 days
  • Verified COVID-19 disease within 14 days before admission
  • Pregnant women
  • Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 <200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (>20 mg/day prednisone or equivalent for >14 days within the last 30 days), Chemotherapy within 30 days)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04651712

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Contact: Mariana Cartuliares +45 23434441
Contact: Helene Skjøt-Arkil, PhD + 45 7997 1113

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Hospital of Southern Jutland Recruiting
Aabenraa, Denmark
Contact: Christian B Mogensen, MD         
Sponsors and Collaborators
University of Southern Denmark
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Study Chair: Christian Backer Mogensen, MD PhD University Hospital of Southern Denmark

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Southern Denmark Identifier: NCT04651712    
Other Study ID Numbers: SHS-ED-11c-2020
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Southern Denmark:
Emergency department
Additional relevant MeSH terms:
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Pneumonia, Bacterial
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Bacterial Infections
Bacterial Infections and Mycoses