PneumoniaULTRASONIC-CAPNCT05741203
Lung Ultrasound in Pediatric CAP
An observational study of Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Community-acquired Pneumonia (CAP) represents the single largest cause of death and morbidity in children worldwide (1). Respiratory viruses are the most common cause of CAP in preschool children, followed by bacteria. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- lung ultrasound
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 30 Apr 2025
- Phase
- Observational
- 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 6 months to 17 years
- All sexes
- Child
Study population: Bambini con diagnosi clinica di infezione delle basse vie respiratorie acuta (ALRTI) (basata su anamnesi, esame clinico, esami del sangue (se eseguiti) e CXR (se eseguiti) sottoposti a LUS entro sei ore dalla prima valutazione clinica
Who may be able to join
- Bambini con diagnosi clinica di infezione delle basse vie respiratorie acuta (ALRTI) (basata su anamnesi, esame clinico, esami del sangue (se eseguiti) e CXR (se eseguiti) sottoposti a LUS entro sei ore dalla prima valutazione clinica
Who cannot join
- Pazienti con patologie preesistenti, tra cui anomalie del tratto respiratorio, immunodeficienza, paralisi cerebrale, malattie neuromuscolari, cardiopatie congenite e tumori maligni
About this study
Official title: Sviluppo di un Sistema di Supporto Alle Decisioni Tramite Software Multiomico Basato su Modelli Preclinici e Dati Point-of-care Clinici e Ecografici Polmonari Per la Gestione Personalizzata Dei Bambini Con Polmonite Acquisita in comunità
Community-acquired Pneumonia (CAP) represents the single largest cause of death and morbidity in children worldwide (1). Respiratory viruses are the most common cause of CAP in preschool children, followed by bacteria. The atypical bacteria Mycoplasma pneumoniae and Chlamydia pneumoniae are common causes of pneumonia in children \>5 years. The identification of the causal agent is pivotal, especially in children who require hospital admission, as it guides the choice of appropriate treatment. However, the microbial diagnosis of CAP in children is not easy to establish without invasive procedures, and chest X-Ray has failed to identify the aetiology of CAP. Clinical features of bacterial pneumonia, atypical bacterial pneumonia or viral pneumonia frequently overlap and cannot be used reliably to distinguish between the various aetiologies, as well as blood tests like white blood cell, C-reactive protein, including the more recently introduced serum procalcitonin (85% sensitivity and 45% specificity in identifying children without typical bacterial CAP. As a consequence, children with CAP usually receive unnecessary empirical antibiotics, contributing to the spread of antibiotic resistance or to side effects. Therefore, new methods, possibly fast, non- invasive and easily accessible in the outpatient settings (point-of-care) to optimize and personalize the management of children with suspected CAP are urgently needed
Specific aim 1 To perform a clinical prospective study aimed to evaluate clinical, laboratory, microbiolical and outcomes data and to define LUS patterns (ultrasonomic) in children with CAP of different aetiologies: (viral, bacterial and atypical CAP) in different italian regions (Lazio, Puglia).
Specific Aim 2 Development and validation of multi-factorial prediction models for the personalized diagnosis and management of paediatric CAP and building of a Decision Support System (DSS) based on validated prediction models that will be build based on the collection of \"ultrasonomic\", clinical, laboratory, treatments, outcomes and microbiological data collected from all partners. In particular, we will: i) develop, validate, and improve prediction models for the prediction of aetiology, outcome and treatment response; ii) take advantage of prediction models to better inform patients/caregivers on the risks and benefits of the proposed treatments; iii) use the outcome of the prediction models to individualize the management
- Conditions
- Pneumonia
- Being tested
- lung ultrasound
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundDiagnostic test
lung ultrasound
| Study group | Role | What they receive |
|---|---|---|
| children with LRTI | Not described Receives: Diagnostic Test: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
pneumonia aetiology
definition of characteristics predictive of viral vs bacterial pneumonia
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741203
- Sponsor's protocol ID
- ID 5474
- Acronym
- ULTRASONIC-CAP
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sviluppo di un Sistema di Supporto Alle Decisioni Tramite Software Multiomico Basato su Modelli Preclinici e Dati Point-of-care Clinici e Ecografici Polmonari Per la Gestione Personalizzata Dei Bambini Con Polmonite Acquisita in comunità
- ClinicalTrials.gov ID
- NCT05741203
- Acronym / sponsor ID
- ULTRASONIC-CAP / ID 5474
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 23 Feb 2023 (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.
Community-acquired Pneumonia (CAP) represents the single largest cause of death and morbidity in children worldwide (1). Respiratory viruses are the most common cause of CAP in preschool children, followed by bacteria. The atypical bacteria Mycoplasma pneumoniae and Chlamydia pneumoniae are common causes of pneumonia in children \>5 years. The identification of the causal agent is pivotal, especially in children who require hospital admission, as it guides the choice of appropriate treatment. However, the microbial diagnosis of CAP in children is not easy to establish without invasive procedures, and chest X-Ray has failed to identify the aetiology of CAP. Clinical features of bacterial pneumonia, atypical bacterial pneumonia or viral pneumonia frequently overlap and cannot be used reliably to distinguish between the various aetiologies, as well as blood tests like white blood cell, C-reactive protein, including the more recently introduced serum procalcitonin (85% sensitivity and 45% specificity in identifying children without typical bacterial CAP. As a consequence, children with CAP usually receive unnecessary empirical antibiotics, contributing to the spread of antibiotic resistance or to side effects. Therefore, new methods, possibly fast, non- invasive and easily accessible in the outpatient settings (point-of-care) to optimize and personalize the management of children with suspected CAP are urgently needed
Specific aim 1 To perform a clinical prospective study aimed to evaluate clinical, laboratory, microbiolical and outcomes data and to define LUS patterns (ultrasonomic) in children with CAP of different aetiologies: (viral, bacterial and atypical CAP) in different italian regions (Lazio, Puglia).
Specific Aim 2 Development and validation of multi-factorial prediction models for the personalized diagnosis and management of paediatric CAP and building of a Decision Support System (DSS) based on validated prediction models that will be build based on the collection of \"ultrasonomic\", clinical, laboratory, treatments, outcomes and microbiological data collected from all partners. In particular, we will: i) develop, validate, and improve prediction models for the prediction of aetiology, outcome and treatment response; ii) take advantage of prediction models to better inform patients/caregivers on the risks and benefits of the proposed treatments; iii) use the outcome of the prediction models to individualize the management
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with LRTI | – | Diagnostic Test: lung ultrasound |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Bambini con diagnosi clinica di infezione delle basse vie respiratorie acuta (ALRTI) (basata su anamnesi, esame clinico, esami del sangue (se eseguiti) e CXR (se eseguiti) sottoposti a LUS entro sei ore dalla prima valutazione clinica
Key inclusion criteria (1 listed)
- Bambini con diagnosi clinica di infezione delle basse vie respiratorie acuta (ALRTI) (basata su anamnesi, esame clinico, esami del sangue (se eseguiti) e CXR (se eseguiti) sottoposti a LUS entro sei ore dalla prima valutazione clinica
Key exclusion criteria (1 listed)
- Pazienti con patologie preesistenti, tra cui anomalie del tratto respiratorio, immunodeficienza, paralisi cerebrale, malattie neuromuscolari, cardiopatie congenite e tumori maligni
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 ultrasoundlung ultrasound | Diagnostic test | children with LRTI |
Primary outcome
pneumonia aetiology
Time frame: 2 years
definition of characteristics predictive of viral vs bacterial pneumonia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
pneumonia aetiology (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2023.