Pneumonia Clinical Trials

Find Pneumonia Clinical Trials Near You

Lung Ultrasound for Antibiotic Stewardship in Community-Acquired Pneumonia: A Randomized Clinical Trial

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 10
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Rady Childrens/UCSD
ACTIVE_NOT_RECRUITING
San Diego
Connecticut
Yale New Haven Children's Hospital
RECRUITING
New Haven
New York
Columbia University
NOT_YET_RECRUITING
New York
Wisconsin
University of Wisconsin
ACTIVE_NOT_RECRUITING
Madison
Other Locations
Israel
Schneider Children's Hospital
NOT_YET_RECRUITING
Petah Tikva
Italy
ASST Papa Giovanni XXIII
RECRUITING
Bergamo
IRCCS Sant'Orsola
RECRUITING
Bologna
Ospedale dei Bambini
NOT_YET_RECRUITING
Brescia
Meyer Children's Hospital IRCCS
RECRUITING
Florence
IRCCS Istituto Giannina Gaslini
RECRUITING
Genova
IRCCS Fondazione Cà Granda - Policlinico
ACTIVE_NOT_RECRUITING
Milan
Ospedale Pediatrico Santobono - Pausillipon
NOT_YET_RECRUITING
Naples
Ospedale Maggiore della Carità
RECRUITING
Novara
Azienda Ospedale Università di Padova
RECRUITING
Padova
IRCCS Gemelli
ACTIVE_NOT_RECRUITING
Roma
Ospedale Pediatrico Bambino Gesù
NOT_YET_RECRUITING
Roma
Ospedale Infantile Regina Margherita
NOT_YET_RECRUITING
Torino
Ospedale Burlo Garofolo
NOT_YET_RECRUITING
Trieste
Contact Information
Primary
Niccolò Parri, MD
niccolo.parri@meyer.it
+390555662320/2634
Backup
Martina Cecchetti, MD
luscaptrial@gmail.com
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 659
Treatments
No_intervention: Control group - standard of care
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: Experimental Group - Lung Ultrasound (LUS)
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
Related Therapeutic Areas
Sponsors
Collaborators: Hospital of Prato, Santobono-Pausilpon Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Fondazione C.N.R./Regione Toscana G. Monasterio, Pisa, Italy, IRCCS Burlo Garofolo, Clinica Pediatrica Università di Novara, Asst Degli Spedali Civili Di Brescia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Università degli Studi 'G. d'Annunzio' Chieti e Pescara, University of Melbourne, Yale University, Columbia University, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Schneider Children's Medical Center, Israel, University Hospital Padova, Gaslini Children's Hospital, Bambino Gesù Hospital and Research Institute
Leads: Meyer Children's Hospital IRCCS

This content was sourced from clinicaltrials.gov