Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin

NCT ID: NCT04217980

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-21
• Study Completion Date: 2019-12-03

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.

Conditions

Pneumonia Childhood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Lung ultrasonography (LUS) group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Sant Joan de Déu

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Sant Joan de Deu

Barcelona, , Spain

Fundació Sant Joan de Déu

Esplugues de Llobregat, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 38581075 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33032612 (View on PubMed)

Other Identifiers

FSJD-NEUMO-2017

Identifier Type: -

Identifier Source: org_study_id