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OpenTrials
Completed

NCT Number: NCT04217980

Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin

Lung ultrasound (LUS) in combination with a biomarker has not yet been studied. The investigators propose a clinical trial where the primary aims are: 1. To assess whether an algorithm with LUS and procalcitonin (PCT) may be useful for diagnosing bacterial pneumonia; 2. To analyse the sensitivity and specificity of LUS vs chest radiograph (CXR).

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Key information

Age range

7 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Deu, Barcelona, Spain

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About this study

Objectives: The general objective is to analyze whether a new algorithm approach of severe pneumonia in pediatric intensive unit (PICU) improves the quality of care. Objectives: 1- To analyze the sensitivity and specificity of lung ultrasound (LUS) compared respect to the chest radiography (CXR) in severe pneumonia and if LUS discriminates between bacterial and viral one. 2- If there is a lower CXR indication. 3- If is possible to reduce the dose of irradiation and costs associated with CXR. 4- To analyze the interobserver agreement of the LUS. 5- determine whether a diagnosis of pneumonia algorithm using LUS and procalcitonin may be useful in directing the indication of antibiotic therapy and / or the duration thereof.

Methodology: clinical, prospective, controlled, randomized, blinded intervention and 3-year trial. Inclusion of children under 18 years, with severe pneumonia, who enter (PICU). Experimental Group 1: pediatrician researcher (PR) will conduct a LUS at admission time, as a first test of lung image; in Group 2, CXR is conduced as first image. Patients will be classified into 3 subgroups, in both branches: a) if PCT is <1 ng /L and LUS is not suggestive of bacterial pneumonia, no antibiotic will be prescribed; b) if LUS is suggestive of bacterial pneumonia, regardless of the PCT, it will be recommended to start antibiotic therapy; c) If the ultrasound is suggestive of bacterial pneumonia but PCT is> 1 ng / L, antibiotic therapy will be recommended to cover other causes of infection. The same attitude will be performed, but depending on the CXR instead of the LUS, in group 2. Clinical variables, complementary tests and evolution data will be collected. Statistics by SPPS® 20.0. Informed consent will be requested and the study will be conducted according to the Helsinki Declaration guidelines and Good Clinical Practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children under 18
  • severe pneumonia criteria
  • admitted at PICU
  • informed consent signed

Exclusion criteria

  • previous respiratory disease (cystic fibrosis and/or immunosuppression)
  • Nosocomial pneumonia development while in charge for community pneumonia.
  • Researcher pediatrician has valuated the chest X ray before the PICU admission
  • Included in other clinical trial

Treatment and study plan

Lung ultrasonography (LUS) or Chest X ray (CXR)

Diagnostic Test

pediatrician researcher (PR) will conduct a LUS or CXR at admission time as a first test of lung image depending on randomized group.

Primary outcomes

  1. Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosis

    Time frame: through study completion, an average of 2 years

    Sens and Spe for LUS group and for X-Ray group

Secondary outcomes

  1. antibiotic days of treatment

    Time frame: through study completion, an average of 2 years

    antibiotic duration for CXR group and antibiotic duration for LUS group

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Registry information

Official study title

Analysis of a Diagnostic Algorithm of Severe Pneumonia in Pediatric Critical Patients by Pulmonary Ultrasound and Procalcitonin as a Plan to Improve the Quality of Care

Acronym: PROLUSP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 6, 2020
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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