Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-05 @ 5:37 PM
Study NCT ID:
NCT06856967
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709769', 'term': 'nirsevimab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-02-26', 'studyFirstSubmitQcDate': '2025-02-26', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.', 'timeFrame': 'November 2024-March 2025'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Synctial Virus Infections']}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the impact of Nirsevimab, a monoclonal antibody used for RSV prophylaxis, on reducing RSV- related hospitalizations. It will be conducted at 8 pediatric departments in Tuscany, Italy. First, a matched case-control study investigates the real-world effectiveness of Nirsevimab in preventing RSV-related lower respiratory tract infection (LRTI) hospitalizations during the RSV epidemic season 2024-2025. Second, a descriptive study examines how the Nirsevimab immunization campaign affects RSV epidemiology, focusing on patients' age, comorbidities, infection severity, and clinical outcomes. The findings aim to optimize RSV prevention strategies and inform public health policies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants \\< 12 months during RSV 2024-2025 epidemic season', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCase patients\n\n* Age \\<12 months\n* Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission\n* Positive RSV PCR on nasopharyngeal swab Control patients\n* Age \\<12 months\n* Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission\n* Hospitalized for conditions other than respiratory infections\n\nExclusion Criteria:\n\n* Parental refusal\n* Previous immunization with Palivizumab\n* Previous maternal RSV vaccine immunization during pregnancy'}, 'identificationModule': {'nctId': 'NCT06856967', 'briefTitle': 'Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.', 'organization': {'class': 'OTHER', 'fullName': "Meyer Children's Hospital IRCCS"}, 'officialTitle': 'Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: A Case-Control Study', 'orgStudyIdInfo': {'id': 'RAENHoB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Patients aged \\<1 years hospitalized with confirmed bronchiolitis', 'interventionNames': ['Drug: Nirsevimab']}, {'label': 'Controls', 'description': 'Patients aged \\<1 years hospitalized for condition other than confirmed bronchiolitis', 'interventionNames': ['Drug: Nirsevimab']}], 'interventions': [{'name': 'Nirsevimab', 'type': 'DRUG', 'description': 'Evaluation of drug exposure in cases and controls', 'armGroupLabels': ['Cases', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52100', 'city': 'Arezzo', 'state': 'Arezzo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Martini Marco, MD', 'role': 'CONTACT', 'email': 'marco.martini@uslsudest.toscana.it', 'phone': '+390575 255531'}], 'facility': 'SOC Pediatria Ospedale San Donato', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}, {'zip': '50012', 'city': 'Bagno a Ripoli', 'state': 'Firenze', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mirri Gianpaolo, MD', 'role': 'CONTACT', 'email': 'gianpaolo.mirri@uslcentro.toscana.it', 'phone': '+39055 6936436'}], 'facility': 'SOC Pediatria Ospedale Santa Maria Annunziata', 'geoPoint': {'lat': 43.75115, 'lon': 11.32252}}, {'zip': '50134', 'city': 'Florence', 'state': 'Firenze', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lori Ilaria, MD', 'role': 'CONTACT', 'email': 'ilaria.lori@uslcentro.toscana.it', 'phone': '+39055 6932201'}], 'facility': 'SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '50139', 'city': 'Florence', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Indolfi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Meyer Children's Hospital IRCCS", 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '56123', 'city': 'Pisa', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Diego Peroni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '51100', 'city': 'Pistoia', 'state': 'Pistoia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Agostiniani RIno, MD', 'role': 'CONTACT', 'email': 'rino1.agostiniani@uslcentro.toscana.it', 'phone': '+390573 351122 - 0573 351121'}], 'facility': 'SOC Pediatria e Neonatologia Ospedale San Jacopo', 'geoPoint': {'lat': 43.93064, 'lon': 10.92365}}, {'zip': '59100', 'city': 'Prato', 'state': 'Prato', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vasarri Pierluigi, MD', 'role': 'CONTACT', 'email': 'pierluigi.vasarri@uslcentro.toscana.it', 'phone': '+390574802367-2350'}], 'facility': 'SOC Pediatria e Neonatologia Ospedale Santo Stefano', 'geoPoint': {'lat': 43.8805, 'lon': 11.09699}}, {'zip': '53100', 'city': 'Siena', 'state': 'Siena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Grosso Salvatore, Professor, MD', 'role': 'CONTACT', 'email': 'salvatore.grosso@uslcentro.toscana.it', 'phone': '+300577 585292'}], 'facility': 'SOC Pediatria AOU Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], 'centralContacts': [{'name': 'Giuseppe Indolfi', 'role': 'CONTACT', 'email': 'giuseppe.indolfi@meyer.it', 'phone': '+3905556621'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Meyer Children's Hospital IRCCS", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Giuseppe Indolfi', 'investigatorAffiliation': "Meyer Children's Hospital IRCCS"}}}}