Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin (PROLUSP)
Primary Purpose
Pneumonia Childhood
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lung ultrasonography (LUS) or Chest X ray (CXR)
Sponsored by
About this trial
This is an interventional diagnostic trial for Pneumonia Childhood focused on measuring pneumonia, lung ultrasound, biomarkers, procalcitonin, childhood
Eligibility Criteria
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
Sites / Locations
- Hospital Sant Joan de Deu
- Fundació Sant Joan de Déu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lung ultrasonography (LUS) group
Chest X ray (CXR) group
Arm Description
Group 1: Lung ultrasonography is performed as the main (first) pulmonary image test
Group 2: Chest X ray is performed as main (first) pulmonary image test
Outcomes
Primary Outcome Measures
Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosis
Sens and Spe for LUS group and for X-Ray group
Secondary Outcome Measures
antibiotic days of treatment
antibiotic duration for CXR group and antibiotic duration for LUS group
Full Information
NCT ID
NCT04217980
First Posted
December 3, 2019
Last Updated
January 8, 2020
Sponsor
Fundació Sant Joan de Déu
1. Study Identification
Unique Protocol Identification Number
NCT04217980
Brief Title
Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin
Acronym
PROLUSP
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
September 9, 2019 (Actual)
Study Completion Date
December 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia Childhood
Keywords
pneumonia, lung ultrasound, biomarkers, procalcitonin, childhood
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung ultrasonography (LUS) group
Arm Type
Experimental
Arm Description
Group 1: Lung ultrasonography is performed as the main (first) pulmonary image test
Arm Title
Chest X ray (CXR) group
Arm Type
Active Comparator
Arm Description
Group 2: Chest X ray is performed as main (first) pulmonary image test
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung ultrasonography (LUS) or Chest X ray (CXR)
Intervention Description
pediatrician researcher (PR) will conduct a LUS or CXR at admission time as a first test of lung image depending on randomized group.
Primary Outcome Measure Information:
Title
Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosis
Description
Sens and Spe for LUS group and for X-Ray group
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
antibiotic days of treatment
Description
antibiotic duration for CXR group and antibiotic duration for LUS group
Time Frame
through study completion, an average of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Sant Joan de Deu
City
Barcelona
Country
Spain
Facility Name
Fundació Sant Joan de Déu
City
Esplugues de Llobregat
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33032612
Citation
Rodriguez-Fanjul J, Guitart C, Bobillo-Perez S, Balaguer M, Jordan I. Procalcitonin and lung ultrasound algorithm to diagnose severe pneumonia in critical paediatric patients (PROLUSP study). A randomised clinical trial. Respir Res. 2020 Oct 8;21(1):255. doi: 10.1186/s12931-020-01476-z.
Results Reference
derived
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Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin
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