Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
Study NCT ID:
NCT06876766
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-03-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Pediatric Lung Ultrasound on Antibiotic Prescriptions in Hospitalized Children and Adolescents With Lower Respiratory Tract Infections. A Randomized Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-20', 'size': 756906, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-08T15:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 176}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibiotic Prescription Rate Upon Discharge', 'timeFrame': 'Upon discharge (up to 30 days).', 'description': 'The primary outcome is the rate of antibiotic prescriptions at the time of discharge. This will compare the proportion of children and adolescents with lower respiratory tract infections (LRTIs) who are prescribed antibiotics upon discharge in the experimental group (Lung Ultrasound \\[LUS\\]) versus the control group (Sham Lung Ultrasound \\[SLUS\\]) or standard care. The aim is to assess whether the use of LUS can reduce unnecessary antibiotic prescriptions at discharge.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lower Resp Tract Infection']}, 'descriptionModule': {'briefSummary': "Title: Effect of Pediatric Lung Ultrasound on Antibiotic Prescriptions in Hospitalized Children and Adolescents with Lower Respiratory Tract Infections (PLUS-AP Trial)\n\nPurpose of the Study:\n\nThis study is being done to find out if a type of imaging called lung ultrasound (LUS) can help doctors decide when to stop antibiotics in children and teens who are in the hospital with lung infections, like pneumonia. Antibiotics are often given to these patients, but sometimes they are used for longer than necessary, which can be harmful. The investigators want to see if using LUS helps doctors make decisions that reduce unnecessary antibiotic use, which can help prevent antibiotic resistance and other complications.\n\nWhat is Lung Ultrasound (LUS)? Lung ultrasound is a safe, non-invasive, and painless test that uses sound waves to look at the lungs. It doesn't involve radiation like chest X-rays. It is already being used to help doctors understand lung conditions, and this study will test if it can also help in deciding when to stop antibiotics.\n\nHow the Study Works:\n\nParticipants: Children and adolescents (ages 3 months-18 years) who are admitted to the hospital with a lung infection.\n\nGroups:\n\nLUS Group: These patients will have a lung ultrasound within 24 hours of enrollment. The results will help guide decisions about when to stop antibiotics.\n\nStandard Care Group: These patients will receive regular hospital care, which may include chest X-rays and other tests to guide their treatment.\n\nWhat Will Be Measured?\n\nPrimary Goal: The study will measure how long children and teens stay on antibiotics. The investigators are testing whether LUS can help shorten this time without affecting their recovery.\n\nSecondary Goals: Investigators will also look at how long patients stay in the hospital, whether they need further treatment or care after leaving.\n\nWhy is This Important? If this study shows that LUS can safely reduce the use of antibiotics, it could change how doctors treat lung infections in children. Reducing unnecessary antibiotic use can help fight antibiotic resistance and protect children from side effects of unnecessary treatments.", 'detailedDescription': "The PLUS-AP Trial (Pediatric Lung Ultrasound to Guide Antibiotic Prescriptions for Hospitalized Children and Adolescents with Lower Respiratory Tract Infections) is a randomized controlled trial designed to assess the effect of pediatric lung ultrasound (LUS) on antibiotic prescribing practices for children and adolescents hospitalized with lower respiratory tract infections (LRTIs). This study aims to explore whether incorporating LUS into clinical decision-making can reduce the unnecessary use of antibiotics without compromising patient care.\n\nBackground:\n\nAntibiotics are frequently overprescribed for LRTIs in pediatric populations, contributing to antibiotic resistance and unnecessary adverse events. While chest X-rays are commonly used to diagnose LRTIs, they can be resource-intensive and involve radiation exposure. Lung ultrasound (LUS) is a non-invasive, radiation-free imaging modality that has gained recognition for its utility in diagnosing and monitoring respiratory diseases. This trial will evaluate whether LUS can assist clinicians in making more accurate diagnostic decisions and potentially reduce the use of antibiotics in hospitalized pediatric patients with LRTIs.\n\nStudy Objectives:\n\nPrimary Objective: To assess whether the use of pediatric lung ultrasound (LUS) reduces the duration of antibiotic treatment in hospitalized children and adolescents diagnosed with LRTIs.\n\nSecondary Objectives:\n\nTo evaluate the impact of LUS on the length of hospital stay. To compare clinical outcomes such as the need for escalation to invasive respiratory support, mortality, and readmission rates between the LUS and standard care groups.\n\nTo assess the cost-effectiveness of LUS implementation in managing pediatric LRTIs.\n\nStudy Design:\n\nThe PLUS-AP trial is designed as a phase III, randomized, controlled, patient blinded, single center superiority trial with two parallel groups and a primary endpoint of antibiotic prescriptions by the day of discharge from the hospital. Randomization will be performed as permuted block randomization with a 1:1 allocation.\n\nLUS Group: Participants will undergo lung ultrasound within 24 hours of enrollment, and the results will be used to guide antibiotic therapy decisions, including the duration of antibiotic treatment.\n\nStandard Care Group: Participants will receive standard care, which includes clinical evaluation and any other diagnostic tests, such as chest X-ray, as deemed necessary by the treating physician.\n\nStudy Population:\n\nInclusion Criteria:\n\n* Age between 3 months and 17 years old inclusive\n* Currently admitted to the pediatric Ward or boarding in the Emergency Department within 24 hours of admission order due to lower respiratory tract infections.\n\nExclusion Criteria:\n\n* Sickle cell disease (SCD).\n* On chemotherapy or any other immunosuppressive therapy except systemic corticosteroids use of ≤ 5 days duration.\n* Cystic fibrosis and other chronic lung diseases except asthma\n* Pre-existing and/or congenital neurologic, metabolic, and cardiac conditions\n* Hospitalized within the previous month\n* Patients with suspected foreign body aspiration -Received antibiotic therapy within the previous week\n* Patients admitted under PI's care\n\nStudy Interventions:\n\nLung Ultrasound (LUS): The ultrasound will be exclusively performed by the principal investigator (A.I.), who has credentialing in LUS with more than 4 years of experience, and will be blinded to CXR results. It will take less than 15 minutes, with follow-up scans conducted within 48 hours or prior to discharge to monitor disease progression.\n\nStandard Care: The control group will follow typical hospital procedures, with diagnosis and treatment guided by clinical examination and routine diagnostic tests such as chest X-ray.\n\nOutcome Measures:\n\nPrimary Outcome: investigate the effect of adding LUS to standard care on the endpoint of antibiotic prescriptions upon discharge in children hospitalized with LRTIs, compared to standard care and SLUS.\n\nSecondary Outcomes:\n\nTo investigate the effect of adding LUS to standard care, as compared to standard care with SLUS, on the end points of:\n\nTrial design\n\n* Length of stay in the hospital\n* Rate of complications by 4 weeks after enrollment: admission to ICU, chest tube insertion, mortality\n* Frequency of CXR performance within 4 weeks of enrollment\n* Rate of antibiotic intake assessed 4 weeks after enrollment\n* Rate of hospital readmission within 4 weeks of enrollment.\n\nExpected Impact:\n\nThe results of this trial could potentially change clinical practices by providing evidence supporting the use of LUS in reducing unnecessary antibiotic use, thereby reducing the burden of antibiotic resistance in pediatric populations. It could also contribute to the safe and more efficient management of LRTIs in hospitalized children and adolescents.\n\nEstimated Study Timeline:\n\nStudy Start Date: april 2025 Study Completion Date: noveber 2026\n\nSponsor and Investigators:\n\nPrincipal Investigator: Dr. Ali Ismail Co-Investigators: Dr. Marianne Majdalani, Dr. Jihane Moukhaiber, and others."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 3 months and 17 years old inclusive\n* Currently admitted to the pediatric Ward or boarding in the Emergency Department within 24 hours of admission order due to lower respiratory tract infections.\n\nExclusion Criteria:\n\n* Sickle cell disease (SCD).\n* On chemotherapy or any other immunosuppressive therapy except systemic corticosteroids use of ≤ 5 days duration.\n* Cystic fibrosis and other chronic lung diseases except asthma\n* Pre-existing and/or congenital neurologic, metabolic, and cardiac conditions\n* Hospitalized within the previous month\n* Patients with suspected foreign body aspiration -Received antibiotic therapy within the previous week\n* Patients admitted under PI's care"}, 'identificationModule': {'nctId': 'NCT06876766', 'acronym': 'PLUS-AP', 'briefTitle': 'Effect of Pediatric Lung Ultrasound on Antibiotic Prescriptions in Hospitalized Children and Adolescents With Lower Respiratory Tract Infections. A Randomized Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Effect of Pediatric Lung Ultrasound on Antibiotic Prescriptions in Hospitalized Children and Adolescents With Lower Respiratory Tract Infections.', 'orgStudyIdInfo': {'id': 'BIO-2024-0304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Lung Ultrasound ''LUS''", 'description': 'Participants in this group will undergo a lung ultrasound within 24 hours of enrollment. The results of this ultrasound will be used to help guide decisions about when to stop antibiotic therapy, aiming to reduce unnecessary antibiotic use.', 'interventionNames': ['Device: Lung Ultrasound']}, {'type': 'SHAM_COMPARATOR', 'label': "Sham lung ultrasound ''SLUS''", 'description': 'Participants in this group will receive the standard clinical care for lower respiratory tract infections, which may include diagnostic tests such as chest X-ray, with antibiotic therapy managed according to the usual clinical protocols.', 'interventionNames': ['Device: Sham']}], 'interventions': [{'name': 'Lung Ultrasound', 'type': 'DEVICE', 'description': 'Lung ultrasound (LUS) is a non-invasive, radiation-free imaging technique that uses sound waves to visualize the lungs. It will be used in the experimental arm to help guide decisions regarding antibiotic therapy in hospitalized children and adolescents with lower respiratory tract infections (LRTIs). The LUS will be performed within 24 hours of enrollment.', 'armGroupLabels': ["Lung Ultrasound ''LUS''"]}, {'name': 'Sham', 'type': 'DEVICE', 'description': 'In the sham group, participants will undergo a mock or placebo version of the lung ultrasound. This involves performing the procedure in a way that mimics the real ultrasound process but does not provide any diagnostic results or influence clinical decision-making regarding antibiotic therapy.', 'armGroupLabels': ["Sham lung ultrasound ''SLUS''"]}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}