Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
Recruiting
Observational Study
Respiratory Synctial Virus Infections
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- Up to 12 Months
- Sex
- Any
- Study type
- Observational
- Participants needed
- 138 (estimated)
- Sponsor
- Meyer Children's Hospital IRCCS · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 R…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
Case patients
* 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 condit…
Contacts