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

• Sponsor: Fundació Sant Joan de Déu (Other)
• Overall Status: Completed
• CT.gov ID: NCT04217980
• Collaborator: (none)
• Enrollment: 202
• Locations: 2
• Arms: 2
• Actual Duration (Months): 26.4
• Patients Per Site: 101
• Patients Per Site Per Month: 3.8

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Childhood	Diagnostic Test: Lung ultrasonography (LUS) or Chest X ray (CXR)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 202 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Sep 21, 2017
• Actual Primary Completion Date: Sep 9, 2019
• Actual Study Completion Date: Dec 3, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosis [through study completion, an average of 2 years]

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

Secondary Outcome Measures

1. antibiotic days of treatment [through study completion, an average of 2 years]

   antibiotic duration for CXR group and antibiotic duration for LUS group

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Days to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Sant Joan de Deu	Barcelona		Spain
2	Fundació Sant Joan de Déu	Esplugues de Llobregat		Spain

Sponsors and Collaborators

• Fundació Sant Joan de Déu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundació Sant Joan de Déu
• ClinicalTrials.gov Identifier: NCT04217980
• Other Study ID Numbers: FSJD-NEUMO-2017
• First Posted: Jan 6, 2020
• Last Update Posted: Jan 13, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fundació Sant Joan de Déu: pneumonia; lung ultrasound; biomarkers; procalcitonin; childhood
• Additional relevant MeSH terms: Pneumonia

Study Results

No Results Posted as of Jan 13, 2020