Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin (PROLUSP)

January 8, 2020 updated by: Fundació Sant Joan de Déu

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Sant Joan de Déu
      • Esplugues de Llobregat, Spain
        • Fundació Sant Joan de Déu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lung ultrasonography (LUS) group
Group 1: Lung ultrasonography is performed as the main (first) pulmonary image test
Diagnostic test: Lung ultrasonography (LUS) or Chest X ray (CXR)
pediatrician researcher (PR) will conduct a LUS or CXR at admission time as a first test of lung image depending on randomized group.
Active Comparator: Chest X ray (CXR) group
Group 2: Chest X ray is performed as main (first) pulmonary image test
Diagnostic test: Lung ultrasonography (LUS) or Chest X ray (CXR)
pediatrician researcher (PR) will conduct a LUS or CXR at admission time as a first test of lung image depending on randomized group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Sant Joan de Déu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2017

Primary Completion (Actual)

September 9, 2019

Study Completion (Actual)

December 3, 2019

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSJD-NEUMO-2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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