Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin

NCT04217980 | Completed

• 1 other identifier: FSJD-NEUMO-2017
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

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).

Conditions

Pneumonia Childhood

Keywords

pneumonia; lung ultrasound; biomarkers; procalcitonin; childhood

Outcome Measures

Primary Outcomes (1)

• Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosis

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

  through study completion, an average of 2 years

Secondary Outcomes (1)

• antibiotic days of treatment

  through study completion, an average of 2 years

Study Arms (2)

Lung ultrasonography (LUS) group

EXPERIMENTAL

Group 1: Lung ultrasonography is performed as the main (first) pulmonary image test

Diagnostic Test: Lung ultrasonography (LUS) or Chest X ray (CXR)

Chest X ray (CXR) group

ACTIVE COMPARATOR

Group 2: Chest X ray is performed as main (first) pulmonary image test

Diagnostic Test: Lung ultrasonography (LUS) or Chest X ray (CXR)

Interventions

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.

Chest X ray (CXR) group; Lung ultrasonography (LUS) group

Eligibility Criteria

• Age: 7 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (2)

Hospital Sant Joan de Deu

Barcelona, Spain

Location

Fundació Sant Joan de Déu

Esplugues de Llobregat, Spain

Location

Related Publications (2)

• Guitart C, Bobillo-Perez S, Rodriguez-Fanjul J, Carrasco JL, Brotons P, Lopez-Ramos MG, Cambra FJ, Balaguer M, Jordan I. Lung ultrasound and procalcitonin, improving antibiotic management and avoiding radiation exposure in pediatric critical patients with bacterial pneumonia: a randomized clinical trial. Eur J Med Res. 2024 Apr 6;29(1):222. doi: 10.1186/s40001-024-01712-y.

  PMID: 38581075 DERIVED

• 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.

  PMID: 33032612 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: January 6, 2020
• Study Start: September 21, 2017
• Primary Completion: September 9, 2019
• Study Completion: December 3, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

ES (2)