Clinical trial NCT04217980: Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin
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
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia Childhood
Keywords: pneumonia
lung ultrasound
biomarkers
procalcitonin
childhood
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 202
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosis
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: antibiotic days of treatment
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
city: Esplugues de Llobregat
country: Spain
facility: Fundació Sant Joan de Déu
Study officials:
References:
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.