NCT03756766

Brief Summary

The study design is a case-control, sample based study. 275 cases (Group 1), infants \<12 months old with RSV infection and 40 controls (Group 2), otherwise healthy infants \<12 months old without RSV infection will be recruited. Samples will be taken on enrolment and for infants in Group 1; repeated at 7 weeks convalescence. There will be annual follow up by questionnaire for up to 6 years and a minimum of 1 year, depending at what stage in the study the infant is enrolled.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Dec 2017Nov 2026

Study Start

First participant enrolled

December 19, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

November 22, 2022

Status Verified

January 1, 2022

Enrollment Period

8.9 years

First QC Date

October 4, 2018

Last Update Submit

November 17, 2022

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (4)

  • Ribonucleic acid (RNA) transcripts (Transcriptomics) that are up and down regulated in severe RSV infection

    Analysis of blood to determine cellular expression of RNA during a severe, acute RSV respiratory tract infection

    8 weeks

  • Cellular protein concentration changes (proteomics) in response to severe RSV infection

    Analysis of blood samples to determine how cellular protein concentrations change in response to severe RSV infection

    8 weeks

  • Cellular metabolite concentration changes associated with severe RSV disease

    Analysis of urine and blood to identify which metabolic pathways are up-regulated at a cellular level following severe RSV infection. This is determined by measuring metabolic by-products

    8 weeks

  • The relationship between infant RSV infection of different severity and school age asthma

    Symptoms of asthma, diagnosis and use of asthma medication will be measured by parental questionnaire/medical records.

    Year 6

Secondary Outcomes (18)

  • Ribonucleic acid (RNA) transcripts that are up or down regulated and contribute to respiratory sequelae following RSV infection in infants

    3 years

  • Cellular protein concentration changes (Proteomics) affecting respiratory sequelae following RSV infection in infants

    3 years

  • Cellular metabolite concentration changes that contribute to respiratory sequelae following RSV infection

    3 years

  • Respiratory sequelae following RSV infection in infants

    3 years

  • Viral load associated with mild and severe RSV disease

    8 weeks

  • +13 more secondary outcomes

Study Arms (2)

RSV positive ARTI

RSV point of care testing will be performed (if result not already available) to confirm RSV positive status. Individuals with confirmed acute respiratory tract infection (ARTI) secondary to RSV (Group 1- active) will have nasopharyngeal swabs, blood samples, urine samples and stool samples taken at the time of recruitment and again at 7 weeks (convalescence). Group 1 participants are categorised into 4 groups as follows: Group 1a and 1b participants are healthy infants with an RSV infection either requiring hospitalisation for at least 12 hours or not requiring hospitalisation respectively. Group 1c \& 1d are infants with an RSV infection with any co-morbidity that would exclude them from Group 1a and 1b either requiring hospitalisation for at least 12 hours or not respectively.

Diagnostic Test: RSV point of care testing

Healthy controls

This group will include healthy infants (Group 2) who do not have an RSV positive respiratory tract infection and have been asymptomatic in the week preceding and following recruitment. This group will have nasopharyngeal swabs, a blood test and a stool and urine sample taken at enrolment only.

Interventions

RSV point of care testingDIAGNOSTIC_TEST

Patients will have 2 nasopharyngeal swabs, a nasal swab, a stool and urine taken at baseline/ enrolment and the RSV positive ARTI group will have samples repeated at 6-8weeks.

Also known as: Venepuncture, Nasopharyngeal swabs, stool sample, Urine sample
RSV positive ARTI

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants less than 12 months old who present to their GP of to hospital with RSV positive respiratory disease.

You may qualify if:

  • parent/carer of the infant is willing and able to give informed consent for participation in the study
  • Male or female, less than 12 months of age at enrolment
  • Parent has a telephone
  • For group 1 only:
  • Hospitalised for \<48 hours at enrolment or within 96 hours of onset of illness
  • Live near enough to a participating study centre for the 6-8 week home visit

You may not qualify if:

  • Infants who have received treatment for RSV infection (eg: ribavirin)
  • Infants who have had prior exposure to an RSV vaccine or medication
  • Infants who have received preventative therapy for RSV (eg; palivizumab)
  • Infants who have received oral steroids or montelukast within 7days of enrolment on the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oxford University Hospitals NHS Trust

Oxford, United Kingdom

Location

Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine

Oxford, United Kingdom

Location

Related Publications (3)

  • McGinley JP, Lin GL, Oner D, Golubchik T, O'Connor D, Snape MD, Gruselle O, Langedijk AC, Wildenbeest J, Openshaw P, Nair H, Aerssens J, Bont L, Martinon-Torres F, Drysdale SB, Pollard AJ; RESCEU Investigators. Clinical and Viral Factors Associated With Disease Severity and Subsequent Wheezing in Infants With Respiratory Syncytial Virus Infection. J Infect Dis. 2022 Aug 12;226(Suppl 1):S45-S54. doi: 10.1093/infdis/jiac163.

    PMID: 35902389DERIVED

  • Jefferies K, Drysdale SB, Robinson H, Clutterbuck EA, Blackwell L, McGinley J, Lin GL, Galal U, Nair H, Aerssens J, Oner D, Langedijk A, Bont L, Wildenbeest JG, Martinon-Torres F, Rodriguez-Tenreiro Sanchez C, Nadel S, Openshaw P, Thwaites R, Widjojoatmodjo M, Zhang L, Nguyen TL, Giaquinto C, Giordano G, Baraldi E, Pollard AJ; RESCEU Investigators. Presumed Risk Factors and Biomarkers for Severe Respiratory Syncytial Virus Disease and Related Sequelae: Protocol for an Observational Multicenter, Case-Control Study From the Respiratory Syncytial Virus Consortium in Europe (RESCEU). J Infect Dis. 2020 Oct 7;222(Suppl 7):S658-S665. doi: 10.1093/infdis/jiaa239.

    PMID: 32794560DERIVED

  • Lin GL, Golubchik T, Drysdale S, O'Connor D, Jefferies K, Brown A, de Cesare M, Bonsall D, Ansari MA, Aerssens J, Bont L, Openshaw P, Martinon-Torres F, Bowden R, Pollard AJ; RESCEU Investigators. Simultaneous Viral Whole-Genome Sequencing and Differential Expression Profiling in Respiratory Syncytial Virus Infection of Infants. J Infect Dis. 2020 Oct 7;222(Suppl 7):S666-S671. doi: 10.1093/infdis/jiaa448.

    PMID: 32702120DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Participants that enrol in Group 1 will have additional consent to retain specimens for the biobank.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Andrew Pollard

    Oxford Vaccine Group

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

November 28, 2018

Study Start

December 19, 2017

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

November 22, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Anonymised individual participant data sets will be shared with other researchers within the RESCEU consortium. These data sets will include information from participants baseline and annual questionnaires and results from bloods, respiratory samples, urine and stool specimens taken at onset of RSV illness and at 6-8 weeks convalescence.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be shared between researchers within the RESCEU consortium as soon as available during the study period. This is currently ongoing. Sharing of the final study information will occur 12-24 months after completion.
Access Criteria
During the study period only researchers involved within the RESCEU consortium will have access to the anonymised individual participant data.

Locations

GB(2)