Pneumonia ChildhoodLUSCAPNCT06921993
Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia
A study testing LUNG ULTRASOUND in people with Pneumonia Childhood and Pneumonia, run by Meyer Children's Hospital IRCCS at 18 sites in 3 countries.
Trial summary
Pneumonia is a major cause of illness and death in children, with an annual incidence of about 3.3 per 1,000 in those under five years old, many requiring hospitalization. The diagnosis is challenging due to the absence of a universally accepted gold standard, leading to variability in emergency settings. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Pneumonia Childhood, Pneumonia, Lung Ultrasound
- What is being tested?
- LUNG ULTRASOUND
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 659 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 24 Apr 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Well-appearing, clinically stable patients aged 3 to 10 years, presenting to the pediatric ED with suspected pneumonia based on a combination of signs and symptoms suggestive of lower respiratory tract infection (LRTI), including:
- Respiratory Symptoms: Cough, Tachypnea, Dyspnea (Increased work of breathing), Abnormal findings on auscultation.
- Systemic Symptoms: Fever, Hypoxia, Decreased appetite.
Who cannot join
- Neonates and children up to 3 years of age, and children older than 10 years
- Children aged 3 to 10 years with any of the following factors:
- Recent hospitalization (within the past 14 days)
- Prior CXR or any other chest imaging (e.g. CT scan)
- Ongoing antibiotic therapy
- Hemodynamic instability
Show all 9Show fewer
- Respiratory failure or severe respiratory distress and/or hypoxemia, requiring urgent assessment for conditions such as pneumothorax, hemothorax, or other emergency respiratory conditions
- History of aspiration or ab ingestis pneumonia
- Underlying medical conditions predisposing to severe or recurrent pneumonia, including immunodeficiency, chronic corticosteroid use, chronic lung disease, malignancy, sickle cell disease, congenital heart disease, tracheostomy, and neuromuscular disorders affecting respiration
Trial locations and contacts
18 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Martina Cecchetti, MD contact
18 sites in 3 countries
Italy13 sites, 11 recruiting
- Recruiting
ASST Papa Giovanni XXIII
Bergamo
- Recruiting
IRCCS Sant'Orsola
Bologna
- Not yet recruiting
Ospedale dei Bambini
Brescia
- Recruiting
Meyer Children's Hospital IRCCS
Florence, Italy, 50139
Niccolò Parri, MD, +390555662634, niccolo.parri@meyer.it
Martina Cecchetti, MD, luscaptrial@gmail.com
- Recruiting
IRCCS Istituto Giannina Gaslini
Genova
- Active, not recruiting
IRCCS Fondazione Cà Granda - Policlinico
Milan
- Not yet recruiting
Ospedale Pediatrico Santobono - Pausillipon
Naples
- Recruiting
Ospedale Maggiore della Carità
Novara
- Recruiting
Azienda Ospedale Università di Padova
Padova
- Active, not recruiting
IRCCS Gemelli
Roma
- Not yet recruiting
Ospedale Pediatrico Bambino Gesù
Roma
- Not yet recruiting
Ospedale Infantile Regina Margherita
Torino
- Not yet recruiting
Ospedale Burlo Garofolo
Trieste
United States4 sites, 2 recruiting
- Active, not recruiting
University of Wisconsin
Madison, Wisconsin, 53706
- Recruiting
Yale New Haven Children's Hospital
New Haven, Connecticut, 06511
- Not yet recruiting
Columbia University
New York, New York, 10027
- Active, not recruiting
Rady Childrens/UCSD
San Diego, California, 92123
Israel1 site, 1 recruiting
- Not yet recruiting
Schneider Children's Hospital
Petah Tikva, 49202
About this study
Official title: Lung Ultrasound for Antibiotic Stewardship in Community-Acquired Pneumonia: A Randomized Clinical Trial
Pneumonia is a major cause of illness and death in children, with an annual incidence of about 3.3 per 1,000 in those under five years old, many requiring hospitalization. The diagnosis is challenging due to the absence of a universally accepted gold standard, leading to variability in emergency settings. Current guidelines recommend diagnosis based on history and physical examination, which do not reliably differentiate pneumonia from other respiratory infections or identify whether it is bacterial or viral in nature. This uncertainty can lead to the unnecessary use of antibiotics.
Commonly used chest X-rays have limitations such as low sensitivity, moderate interobserver reliability, and the inability to distinguish bacterial from viral pneumonia. In contrast, lung ultrasound has shown high sensitivity and specificity for diagnosing pneumonia in children. However, lung ultrasound also cannot reliably distinguish between bacterial and viral causes and might lead to increased antibiotic prescriptions by detecting minor lung consolidations not seen on chest X-rays. Despite these issues, lung ultrasound is widely used in pediatric pulmonary assessment.
Read more
The primary objective of the study is to determine if using lung ultrasound for diagnosing pneumonia in children can reduce antibiotic prescriptions compared to the standard care approach-which mainly relies on clinical diagnosis (often supplemented by chest X-ray and blood tests in selected cases). The secondary objective is to assess how frequently lung ultrasound impacts management decisions during a single clinical visit, beyond the information provided by history and physical examination. The third objective is to compare the diagnostic accuracy of lung ultrasound-supported diagnosis with existing diagnostic methods.
The study hypothesizes that lung ultrasound results can act as a decision modifier, similar to other clinical tools and examination findings. However, a lack of consensus on specific lung ultrasound parameters and their clinical correlations contributes to variability in managing suspected pneumonia, potentially leading to antibiotic overuse.
Eligible participants are children aged three to ten years who are in good general condition and clinically stable, presenting with signs and symptoms of lower respiratory tract infection indicative of pneumonia. Exclusion criteria include children outside the specified age range, those recently hospitalized, those who have undergone prior chest imaging, those already on antibiotic therapy, those with severe clinical instability, and those with underlying conditions predisposing them to severe or recurrent pneumonia. These criteria help ensure that the study population represents general pediatric community-acquired pneumonia cases, avoiding biases from high-risk patients.
The ultimate goal of this study is to provide evidence on whether lung ultrasound can serve as a reliable tool to guide antibiotic prescriptions, thereby reducing unnecessary antibiotic use in the management of pediatric pneumonia.
Read the detailed description
This prospective, randomized, multicenter clinical trial aims to determine whether using lung ultrasound (LUS) in children aged 3-10 years with suspected pneumonia can reduce the prescription of antibiotics, compared to the standard of care (clinical diagnosis, with optional chest X-ray and blood tests). A second objective is to assess how often LUS findings alter clinical decision-making beyond history and physical examination alone, while a third objective compares the diagnostic accuracy of an LUS-based approach to current pathways.
Study Design and Intervention
Children presenting with signs and symptoms of lower respiratory tract infection (e.g., cough, tachypnea, fever) who are clinically stable and in good general condition are eligible.
Exclusion criteria include recent hospitalization, prior imaging, ongoing antibiotic therapy, severe respiratory distress, and underlying conditions predisposing to complicated pneumonia.
Participants are randomized to an experimental group, where LUS is performed immediately after clinical assessment, or a control group, which follows standard care.
Clinicians in both groups may request a chest X-ray if warranted, and the reasons for imaging are documented.
All participants receive routine evaluations, and interventions (e.g., blood tests, antibiotic decisions) remain at the discretion of the treating physician.
Outcomes
Primary Outcome: Reduction in antibiotic prescriptions in the LUS group versus the control group.
Secondary Outcomes:
The rate at which LUS modifies diagnoses and clinical management compared to assessments using only history and physical examination.
Differences in emergency department (ED) length of stay, hospital admission rates, and unscheduled healthcare visits within one week.
Overall diagnostic accuracy of LUS-supported diagnosis compared to standard methods.
Additional Measures:
An expert panel (pediatric radiologist, pulmonologist, and emergency physician) will determine a consensus final diagnosis after reviewing clinical data.
Data Management and Follow-Up
Each patient's care pathway is documented using a 1-5 Likert scale capturing the likelihood of pneumonia and willingness to prescribe antibiotics at various decision points (clinical exam, optional LUS, and optional chest X-ray).
A follow-up call occurs 5-7 days post-discharge to track clinical progress and any subsequent antibiotic use.
Data are recorded and stored in REDCap, with pseudonymized patient identifiers.
No significant risks are anticipated. The benefits include potentially improving diagnostic accuracy and reducing unnecessary antibiotic prescriptions.
Ultimately, this study seeks to clarify whether incorporating LUS into standard pediatric pneumonia assessment can enhance decision-making, leading to more judicious antibiotic use without compromising patient care.
- Being tested
- LUNG ULTRASOUND
- Keywords
- Pneumonia, Children, Pediatrics, Lung ultrasound, point-of-care 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
All subjects randomly assigned to the investigational arm will undergo lung ultrasound (LUS) .
Ultrasound still images and ultrasound clips will be acquired according to the study protocol. Detailed methodology of the ultrasound examination and parameters is provided as appendix to the study protocol
| Study group | Role | What they receive |
|---|---|---|
| Control group - standard of care | No intervention | All subjects randomly assigned to the control arm will undergo a complete patient history and clinical assessment (the reference standard). If there is clinical uncertainty, the enrolling physician has the option to perform other test such as CXR or blood test. |
| Experimental Group - Lung Ultrasound (LUS) | Experimental | All subjects randomly assigned to the investigational arm will undergo lung ultrasound (LUS) . The LUS will be performed immediately following a thorough patient history and complete clinical assessment.
Ultrasound still images and ultrasound clips will be acquired according to the study protocol. Detailed methodology of the ultrasound examination and parameters is provided as appendix to the study protocol Receives: Diagnostic Test: LUNG ULTRASOUND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with antibiotic use
A chart review and follow up phone call made at 1 week (range 5-7 days) to assess whether or not the subject was started on antibiotics during the index ED visit or at a later healthcare visit. The primary objective of this study is to determine if it is possible for LUS to reduce antibiotic prescription when evaluating patients with possible pneumonia. Specifically, an overall reduction of antibiotic when LUS is used as adjunct tool in the
Measured: 7 days
Secondary outcomes (2)
Percentage of participants who had hospital admission
Chart review and follow up phone call made at 1 week (range 5-7 days) to assess whether or not the subject was admitted during the index ED visit or at a later healthcare visit.
Measured: 7 days
Percentage of participants with antibiotic use
A chart review and follow up phone call made at 1 week (range 5-7 days) to assess whether or not the subject was started on antibiotics during the index ED visit or at a later healthcare visit. The primary objective of this study is to determine if it is possible for LUS to reduce antibiotic prescription when evaluating patients with possible pneumonia. Specifically, an overall reduction of antibiotic when LUS is used as adjunct tool in the assessment.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start24 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia ChildhoodStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized diagnostic clinical trial
- Masking
- None (open label)
- Enrolment
- 659 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Gaslini Children's Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University Hospital Padova, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università degli Studi 'G. d'Annunzio' Chieti e Pescara, Bambino Gesù Hospital and Research Institute, Santobono-Pausilpon Hospital, Asst Degli Spedali Civili Di Brescia, IRCCS Burlo Garofolo, Clinica Pediatrica Università di Novara, Hospital of Prato, Columbia University, Schneider Children's Medical Center, Israel, Yale University, University of Melbourne
- Responsible party
- Sponsor
- Investigators
- Niccolò Parri, MD, Study director, Meyer Children's Hospital IRCCS, Florence, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921993
- Sponsor's protocol ID
- LUSCAP
- Acronym
- LUSCAP
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2025
- Last updated
- 3 Apr 2026
- 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound for Antibiotic Stewardship in Community-Acquired Pneumonia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06921993
- Acronym / sponsor ID
- LUSCAP / LUSCAP
- Keywords
- Pneumonia, Children, Pediatrics, Lung ultrasound, point-of-care ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 659 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Gaslini Children's Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University Hospital Padova, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università degli Studi 'G. d'Annunzio' Chieti e Pescara, Bambino Gesù Hospital and Research Institute, Santobono-Pausilpon Hospital, Asst Degli Spedali Civili Di Brescia, IRCCS Burlo Garofolo, Clinica Pediatrica Università di Novara, Hospital of Prato, Columbia University, Schneider Children's Medical Center, Israel, Yale University, University of Melbourne
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 10 Apr 2025 (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.
Pneumonia is a major cause of illness and death in children, with an annual incidence of about 3.3 per 1,000 in those under five years old, many requiring hospitalization. The diagnosis is challenging due to the absence of a universally accepted gold standard, leading to variability in emergency settings. Current guidelines recommend diagnosis based on history and physical examination, which do not reliably differentiate pneumonia from other respiratory infections or identify whether it is bacterial or viral in nature. This uncertainty can lead to the unnecessary use of antibiotics.
Commonly used chest X-rays have limitations such as low sensitivity, moderate interobserver reliability, and the inability to distinguish bacterial from viral pneumonia. In contrast, lung ultrasound has shown high sensitivity and specificity for diagnosing pneumonia in children. However, lung ultrasound also cannot reliably distinguish between bacterial and viral causes and might lead to increased antibiotic prescriptions by detecting minor lung consolidations not seen on chest X-rays. Despite these issues, lung ultrasound is widely used in pediatric pulmonary assessment.
The primary objective of the study is to determine if using lung ultrasound for diagnosing pneumonia in children can reduce antibiotic prescriptions compared to the standard care approach-which mainly relies on clinical diagnosis (often supplemented by chest X-ray and blood tests in selected cases). The secondary objective is to assess how frequently lung ultrasound impacts management decisions during a single clinical visit, beyond the information provided by history and physical examination. The third objective is to compare the diagnostic accuracy of lung ultrasound-supported diagnosis with existing diagnostic methods.
The study hypothesizes that lung ultrasound results can act as a decision modifier, similar to other clinical tools and examination findings. However, a lack of consensus on specific lung ultrasound parameters and their clinical correlations contributes to variability in managing suspected pneumonia, potentially leading to antibiotic overuse.
Eligible participants are children aged three to ten years who are in good general condition and clinically stable, presenting with signs and symptoms of lower respiratory tract infection indicative of pneumonia. Exclusion criteria include children outside the specified age range, those recently hospitalized, those who have undergone prior chest imaging, those already on antibiotic therapy, those with severe clinical instability, and those with underlying conditions predisposing them to severe or recurrent pneumonia. These criteria help ensure that the study population represents general pediatric community-acquired pneumonia cases, avoiding biases from high-risk patients.
The ultimate goal of this study is to provide evidence on whether lung ultrasound can serve as a reliable tool to guide antibiotic prescriptions, thereby reducing unnecessary antibiotic use in the management of pediatric pneumonia.
Detailed description
This prospective, randomized, multicenter clinical trial aims to determine whether using lung ultrasound (LUS) in children aged 3-10 years with suspected pneumonia can reduce the prescription of antibiotics, compared to the standard of care (clinical diagnosis, with optional chest X-ray and blood tests). A second objective is to assess how often LUS findings alter clinical decision-making beyond history and physical examination alone, while a third objective compares the diagnostic accuracy of an LUS-based approach to current pathways.
Study Design and Intervention
Children presenting with signs and symptoms of lower respiratory tract infection (e.g., cough, tachypnea, fever) who are clinically stable and in good general condition are eligible.
Exclusion criteria include recent hospitalization, prior imaging, ongoing antibiotic therapy, severe respiratory distress, and underlying conditions predisposing to complicated pneumonia.
Participants are randomized to an experimental group, where LUS is performed immediately after clinical assessment, or a control group, which follows standard care.
Clinicians in both groups may request a chest X-ray if warranted, and the reasons for imaging are documented.
All participants receive routine evaluations, and interventions (e.g., blood tests, antibiotic decisions) remain at the discretion of the treating physician.
Outcomes
Primary Outcome: Reduction in antibiotic prescriptions in the LUS group versus the control group.
Secondary Outcomes:
The rate at which LUS modifies diagnoses and clinical management compared to assessments using only history and physical examination.
Differences in emergency department (ED) length of stay, hospital admission rates, and unscheduled healthcare visits within one week.
Overall diagnostic accuracy of LUS-supported diagnosis compared to standard methods.
Additional Measures:
An expert panel (pediatric radiologist, pulmonologist, and emergency physician) will determine a consensus final diagnosis after reviewing clinical data.
Data Management and Follow-Up
Each patient's care pathway is documented using a 1-5 Likert scale capturing the likelihood of pneumonia and willingness to prescribe antibiotics at various decision points (clinical exam, optional LUS, and optional chest X-ray).
A follow-up call occurs 5-7 days post-discharge to track clinical progress and any subsequent antibiotic use.
Data are recorded and stored in REDCap, with pseudonymized patient identifiers.
No significant risks are anticipated. The benefits include potentially improving diagnostic accuracy and reducing unnecessary antibiotic prescriptions.
Ultimately, this study seeks to clarify whether incorporating LUS into standard pediatric pneumonia assessment can enhance decision-making, leading to more judicious antibiotic use without compromising patient care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized diagnostic clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group - standard of care | No intervention | –All subjects randomly assigned to the control arm will undergo a complete patient history and clinical assessment (the reference standard). If there is clinical uncertainty, the enrolling physician has the option to perform other test such as CXR or blood test. |
| Experimental Group - Lung Ultrasound (LUS) | Experimental | Diagnostic Test: LUNG ULTRASOUNDAll subjects randomly assigned to the investigational arm will undergo lung ultrasound (LUS) . The LUS will be performed immediately following a thorough patient history and complete clinical assessment. Ultrasound still images and ultrasound clips will be acquired according to the study protocol. Detailed methodology of the ultrasound examination and parameters is provided as appendix to the study protocol |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Well-appearing, clinically stable patients aged 3 to 10 years, presenting to the pediatric ED with suspected pneumonia based on a combination of signs and symptoms suggestive of lower respiratory tract infection (LRTI), including:
Key exclusion criteria (9 listed)
- Neonates and children up to 3 years of age, and children older than 10 years
- Children aged 3 to 10 years with any of the following factors:
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 ULTRASOUNDAll subjects randomly assigned to the investigational arm will undergo lung ultrasound (LUS) . Ultrasound still images and ultrasound clips will be acquired according to the study protocol. Detailed methodology of the ultrasound examination and parameters is provided as appendix to the study protocol | Diagnostic test | Experimental Group - Lung Ultrasound (LUS) |
Primary outcome
Percentage of participants with antibiotic use
Time frame: 7 days
A chart review and follow up phone call made at 1 week (range 5-7 days) to assess whether or not the subject was started on antibiotics during the index ED visit or at a later healthcare visit. The primary objective of this study is to determine if it is possible for LUS to reduce antibiotic prescription when evaluating patients with possible pneumonia. Specifically, an overall reduction of antibiotic when LUS is used as adjunct tool in the
2 secondary outcomes
Percentage of participants who had hospital admission
Time frame: 7 days
Percentage of participants with antibiotic use
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- 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.
Martina Cecchetti, MD contact
Niccolò Parri, MD study director
Meyer Children's Hospital IRCCS, Florence, Italy
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUNG ULTRASOUND in people with Pneumonia Childhood and Pneumonia, run by Meyer Children's Hospital IRCCS at 18 sites in 3 countries.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy, United States, Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niccolò Parri, MD (+390555662320/2634, niccolo.parri@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with antibiotic use (time frame: 7 days). 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 3 Apr 2026.