Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
NCT ID: NCT06856967
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
138 participants
OBSERVATIONAL
2024-12-04
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases
Patients aged \<1 years hospitalized with confirmed bronchiolitis
Nirsevimab
Evaluation of drug exposure in cases and controls
Controls
Patients aged \<1 years hospitalized for condition other than confirmed bronchiolitis
Nirsevimab
Evaluation of drug exposure in cases and controls
Interventions
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Nirsevimab
Evaluation of drug exposure in cases and controls
Eligibility Criteria
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Inclusion Criteria
* Age \<12 months
* Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission
* Positive RSV PCR on nasopharyngeal swab Control patients
* Age \<12 months
* Diagnosis of LRTI (i.e., bronchiolitis and/or pneumonia) at admission
* Hospitalized for conditions other than respiratory infections
Exclusion Criteria
* Previous immunization with Palivizumab
* Previous maternal RSV vaccine immunization during pregnancy
12 Months
ALL
No
Sponsors
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Meyer Children's Hospital IRCCS
OTHER
Responsible Party
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Giuseppe Indolfi
MD
Locations
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SOC Pediatria Ospedale San Donato
Arezzo, Arezzo, Italy
SOC Pediatria Ospedale Santa Maria Annunziata
Bagno a Ripoli, Firenze, Italy
SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio
Florence, Firenze, Italy
Meyer Children's Hospital IRCCS
Florence, Italy, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, Italy
SOC Pediatria e Neonatologia Ospedale San Jacopo
Pistoia, Pistoia, Italy
SOC Pediatria e Neonatologia Ospedale Santo Stefano
Prato, Prato, Italy
SOC Pediatria AOU Senese
Siena, Siena, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RAENHoB
Identifier Type: -
Identifier Source: org_study_id
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