Pneumonia ChildhoodPROLUSPNCT04217980
Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin
A study testing Lung ultrasonography (LUS) or Chest X ray (CXR) in people with Pneumonia Childhood, run by Fundació Sant Joan de Déu at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 days to 18 years
- Conditions the study is for
- Pneumonia Childhood
- What is being tested?
- Lung ultrasonography (LUS) or Chest X ray (CXR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 2 sitesSpain
- Study dates
- 21 Sep 2017to 3 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children under 18
- severe pneumonia criteria
- admitted at PICU
- informed consent signed
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Sant Joan de Deu
Barcelona
Fundació Sant Joan de Déu
Esplugues de Llobregat
About this study
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
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).
Read the 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
- Being tested
- Lung ultrasonography (LUS) or Chest X ray (CXR)
- Keywords
- pneumonia, lung ultrasound, biomarkers, procalcitonin, childhood
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Lung ultrasonography (LUS) group | Experimental | Group 1: Lung ultrasonography is performed as the main (first) pulmonary image test Receives: 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 Receives: Diagnostic Test: Lung ultrasonography (LUS) or Chest X ray (CXR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosis
Sens and Spe for LUS group and for X-Ray group
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
antibiotic days of treatment
antibiotic duration for CXR group and antibiotic duration for LUS group
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start21 Sep 2017
- Primary completion9 Sep 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumonia ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217980
- Sponsor's protocol ID
- FSJD-NEUMO-2017
- Acronym
- PROLUSP
- Status last verified
- Jan 2020
- First submitted
- 3 Dec 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38581075Rodriguez-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.
PubMed 33032612
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04217980
- Acronym / sponsor ID
- PROLUSP / FSJD-NEUMO-2017
- Conditions
- Pneumonia Childhood
- Keywords
- pneumonia, lung ultrasound, biomarkers, procalcitonin, childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung ultrasonography (LUS) group | Experimental | Diagnostic Test: Lung ultrasonography (LUS) or Chest X ray (CXR)Group 1: Lung ultrasonography is performed as the main (first) pulmonary image test |
| Chest X ray (CXR) group | Active comparator | Diagnostic Test: Lung ultrasonography (LUS) or Chest X ray (CXR)Group 2: Chest X ray is performed as main (first) pulmonary image test |
Who may qualify
- Ages
- 7 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- children under 18
- severe pneumonia criteria
- admitted at PICU
- informed consent signed
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Chest X ray (CXR) group, Lung ultrasonography (LUS) group |
Primary outcome
Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosis
Time frame: through study completion, an average of 2 years
Sens and Spe for LUS group and for X-Ray group
1 secondary outcome
antibiotic days of treatment
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 38581075Guitart 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.
- Derived from this study: PubMed 33032612Rodriguez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung ultrasonography (LUS) or Chest X ray (CXR) in people with Pneumonia Childhood, run by Fundació Sant Joan de Déu at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensibility and specificity of LUS and procalcitonin for pneumonia diagnosis (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217980, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.