Respiratory Synctial Virus InfectionsNCT06856967
Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
An observational study of Respiratory Synctial Virus Infections, run by Meyer Children's Hospital IRCCS at 8 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Respiratory Synctial Virus Infections
- What is being tested?
- Nirsevimab
- How many people
- 138 participants
- Where
- 8 sitesItaly
- Study dates
- 4 Dec 2024to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants < 12 months during RSV 2024-2025 epidemic season
Who may be able to join
- 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 conditions other than respiratory infections
Who cannot join
- Parental refusal
- Previous immunization with Palivizumab
- Previous maternal RSV vaccine immunization during pregnancy
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Italy8 sites, 8 recruiting
- Recruiting
SOC Pediatria Ospedale San Donato
Arezzo, Arezzo, 52100
Martini Marco, MD, +390575 255531, marco.martini@uslsudest.toscana.it
- Recruiting
SOC Pediatria Ospedale Santa Maria Annunziata
Bagno a Ripoli, Firenze, 50012
Mirri Gianpaolo, MD, +39055 6936436, gianpaolo.mirri@uslcentro.toscana.it
- Recruiting
SOC Neonatologia e Terapia Intensiva Neonatale, Ospedale San Giovanni Di Dio
Florence, Firenze, 50134
Lori Ilaria, MD, +39055 6932201, ilaria.lori@uslcentro.toscana.it
- Recruiting
Meyer Children's Hospital IRCCS
Florence, Italy, 50139
Giuseppe Indolfi
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56123
Diego Peroni
- Recruiting
SOC Pediatria e Neonatologia Ospedale San Jacopo
Pistoia, Pistoia, 51100
Agostiniani RIno, MD, +390573 351122 - 0573 351121, rino1.agostiniani@uslcentro.toscana.it
- Recruiting
SOC Pediatria e Neonatologia Ospedale Santo Stefano
Prato, Prato, 59100
Vasarri Pierluigi, MD, +390574802367-2350, pierluigi.vasarri@uslcentro.toscana.it
- Recruiting
SOC Pediatria AOU Senese
Siena, Siena, 53100
Grosso Salvatore, Professor, MD, +300577 585292, salvatore.grosso@uslcentro.toscana.it
About this study
Official title: Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: A Case-Control Study
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.
- Conditions
- Respiratory Synctial Virus Infections
- Being tested
- Nirsevimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NirsevimabDrug
Evaluation of drug exposure in cases and controls
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients aged <1 years hospitalized with confirmed bronchiolitis Receives: Drug: Nirsevimab | |
| Controls | Patients aged <1 years hospitalized for condition other than confirmed bronchiolitis Receives: Drug: Nirsevimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.
Measured: November 2024-March 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start4 Dec 2024
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Synctial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Indolfi, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856967
- Sponsor's protocol ID
- RAENHoB
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06856967
- Acronym / sponsor ID
- RAENHoB
- Conditions
- Respiratory Synctial Virus Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Drug: NirsevimabPatients aged <1 years hospitalized with confirmed bronchiolitis |
| Controls | – | Drug: NirsevimabPatients aged <1 years hospitalized for condition other than confirmed bronchiolitis |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants < 12 months during RSV 2024-2025 epidemic season
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Parental refusal
- Previous immunization with Palivizumab
- Previous maternal RSV vaccine immunization during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NirsevimabEvaluation of drug exposure in cases and controls | Drug | Cases, Controls |
Primary outcome
The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group.
Time frame: November 2024-March 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Synctial Virus Infections, run by Meyer Children's Hospital IRCCS at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Indolfi (+3905556621, giuseppe.indolfi@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients immunized with Nirsevimab among children hospitalized for RSV-related LRTI and those in the control group. (time frame: November 2024-March 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.