Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness (THRIVE)

5 maggio 2026 aggiornato da: Menzies School of Health Research

Passive Immunisation With RSV-specific Monoclonal Antibody (RSV-SMA) to Prevent RSV Respiratory Infections Among Aboriginal and Torres Strait Islander Children in the Northern Territory: a Pragmatic Randomised Controlled Trial.

RSV is a leading cause of severe respiratory illness and hospitalisation for young children, with particularly high rates of RSV respiratory infection observed amongst Aboriginal and Torres Strait Islander children living in Australia's Northern Territory. The goal of this clinical trial is to evaluate whether routinely administering a single dose of respiratory syncytial virus (RSV)-specific monoclonal antibody, nirsevimab, from 6 months old, provides protection against RSV infections for Aboriginal and Torres Strait Islander children throughout in the first and second year of life.

In this study, participants will be randomly assigned to receive either a single dose of intra-muscular RSV-specific monoclonal antibody, nirsevimab, or standard care (no RSV-specific monoclonal antibody). The primary objective is to determine whether administration ofRSV-specific monoclonal antibody, nirsevimab reduces the occurrence of RSV infection over the subsequent 12 months. Secondary objectives include assessing whether nirsevimab reduces RSV-related hospital attendances, as well as respiratory and all-cause hospitalisations, over the following 6 and 12 months. An assessment of cost-effectiveness will also be undertaken.

Participants will receive the study intervention at 6 months of age (+90 days). Follow-up will be conducted through passive surveillance using electronic medical records and public health notification systems to capture relevant health outcomes.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study is a pragmatic, parallel-group, randomised controlled trial conducted in the Northern Territory to evaluate an RSV prevention strategy in Aboriginal and Torres Strait Islander infants under real-world conditions.

Eligible infants aged approximately 6 months (+90 days) will be randomised in a 1:1 ratio to receive either a single intramuscular dose of RSV-specific monoclonal antibody (nirsevimab) or standard care. Randomisation will be stratified by geographic region (e.g. Top End and Central Australia), remoteness classification and prior nirsevimab dose status.

At enrolment, baseline data is collected to confirm eligibility and characterise the study population. This includes review of immunisation and birth records and collection of simple clinical measurements such as weight and temperature, consistent with routine care.

The study is designed to minimise participant burden and reflect routine clinical practice. Apart from the study intervention and a brief follow-up contact approximately 7 days after enrolment to assess early safety, no additional procedures or scheduled study visits are required. Participants will otherwise continue to receive standard healthcare through existing services.

Outcome ascertainment will be undertaken using passive follow-up through routinely collected health data. This includes review of hospital medical records and linkage with RSV notifications reported through the Northern Territory notifiable disease surveillance system. These data sources will be used to identify laboratory-confirmed RSV infection, healthcare presentations, and hospital admissions during the follow-up period.

The study incorporates a Bayesian adaptive design, allowing for interim analyses at predefined enrolment milestones. This enables potential early stopping for superiority or futility, ensuring efficient use of resources and minimising unnecessary exposure of participants.

An economic evaluation will be conducted alongside the trial to assess the cost-effectiveness of the intervention using observed healthcare utilisation and outcome data.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1000

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Australia
    • Northern Territory
      • Darwin, Northern Territory, Australia, 0810
        • Menzies School of Health Research
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  1. Aboriginal and/or Torres Strait Islander infant ≥ 6 calendar months old and < 9 calendar months old.
  2. Parent/caregiver is willing for their infant to participate in the study and informed consent for the infant's participation in the study has been given.
  3. Parent/caregiver is willing to comply with all study procedures outlined in the protocol, including review of maternal/ infant immunisation records, electronic medical records and public health notifications, for the duration of the study.

Exclusion Criteria:

  1. Infants with a contra-indication to RSV-SMA per the Australian Immunisation Handbook (i.e. anaphylaxis to a prior dose).
  2. Infants who have received a prior dose of RSV-SMA at ≥ 3 calendar months old.
  3. Previously enrolled in this trial.

Temporary Exclusion Criteria

  1. Infants who have received a prior dose of RSV-SMA between ≥ 1 calendar months old and < 3 calendar months old will be excluded until at least 150 days have passed since their most recent dose. Randomisation can be delayed until participants meet this criterion.
  2. Acute illness at the time of assessment (e.g. fever ≥ 38.5°C, acute respiratory or other infection as determined by trained and delegated study staff) is temporarily excluded until they are recovered and/or symptom-free for ≥ 24 hours.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Nirsevimab (RSV-specific monoclonal antibody)
Participants in the experimental arm will receive a single dose of RSV-specific monoclonal antibody - nirsevimab, administered from 6 months old (+ 90 days) in accordance with the licensed indication for RSV prevention. Dosing will be weight-based (50mg for infants < 5kg, and 100mg for infants ≥5 kg) and administered by unblinded study staff. Participants will continue to receive routine health care and additional immunisations in accordance with the National Immunisation Program and local guidelines.
Biologico: Nirsevimab (RSV-specific monoclonal antibody)
A single intramuscular dose of RSV-specific monoclonal antibody (RSV-SMA) - nirsevimab, will be administered from 6 months old (+ 90 days) to prevent RSV respiratory infections among Aboriginal and Torres Strait Islander children in the first and second year of life. Our randomised clinical trial will be among the first to evaluate the health and economic impact of routinely administering a dose of RSV-SMA from 6 months old in a year-round program for this high-risk population with less distinct RSV infection seasons.
Nessun intervento: Standard Care
Participants in the standard care arm will NOT receive a dose of RSV-specific monoclonal antibody - nirsevimab. Participants will continue to receive routine health care and immunisations in accordance with the National Immunisation Program and local guidelines.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
RSV infection
Lasso di tempo: Before 6-months and 12-months post randomisation date
RSV respiratory infection detected by reverse transcription polymerase chain reaction (RT-PCR) on a respiratory specimen from time of randomisation to before 6-months and before 12-months post-randomisation AND notified to the NT Notifiable Disease System. RSV infection before 12 months post-randomisation is the primary endpoint.
Before 6-months and 12-months post randomisation date

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
RSV hospital attendance
Lasso di tempo: Before 6-months and 12-months post randomisation date
Any emergency department presentation or hospital admission at any time from time of randomisation to before 6-months and before 12- months post-randomisation, AND for which RSV is detected by RT-PCR of a respiratory specimen (regardless of notification) collected at any time from 120 hours before hospital presentation to 72 hours afterwards.
Before 6-months and 12-months post randomisation date
RSV hospitalisation
Lasso di tempo: Before 6-months and 12-months post randomisation date
Subset of RSV hospital attendances resulting in admission to an inpatient service.
Before 6-months and 12-months post randomisation date
RSV hospitalisation - severe
Lasso di tempo: Before 6-months and 12-months post randomisation date.
Subset of RSV hospitalisations WITH any documented oxygen saturation <90% at any point during the clinical presentation in accordance with the World Health Organization case definition, AND WITH documented receipt of supplemental oxygen.
Before 6-months and 12-months post randomisation date.
Respiratory hospitalisation
Lasso di tempo: Before 6-months and 12-months post randomisation date
Any admission to an inpatient service from time of randomisation to before 6 -months and before 12-months post randomisation AND receiving a primary diagnosis consistent with any acute respiratory infection, including bronchiolitis, bronchitis, pneumonia, influenza, whooping cough, or chest/respiratory infection, OR RSV hospitalisation.
Before 6-months and 12-months post randomisation date
Any hospitalisation
Lasso di tempo: Before 6-months and 12-months post randomisation date
Hospital admission to an inpatient service at any time after time of randomisation to before 6-month and before 12-months post randomisation regardless of primary diagnosis.
Before 6-months and 12-months post randomisation date

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Menzies School of Health Research

Collaboratori

University of Sydney
Murdoch Childrens Research Institute

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 maggio 2026

Completamento primario (Stimato)

31 luglio 2030

Completamento dello studio (Stimato)

31 dicembre 2030

Date di iscrizione allo studio

Primo inviato

5 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

11 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GNT2043738

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

De-identified individual data may be shared following consultation with the Australian First Nations Reference Group for Maternal and Child Health, First Nations researchers and Cultural Advisors, and in compliance with Indigenous Data Sovereignty principles.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Virus respiratorio sinciziale (RSV)

Prove cliniche su Nirsevimab (RSV-specific monoclonal antibody)

  • Duke University
    Columbia University; Emory University; Centers for Disease Control and Prevention; Children's Hospital Medical Center, Cincinnati e altri collaboratori
    Reclutamento
    Sicurezza dell'anticorpo monoclonale preventivo RSV
    Febbre | Evento avverso dopo l'immunizzazione
    Stati Uniti

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Thailand

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi