NCT04925310

Brief Summary

IRIS (Infection with RespIratory Syncytial Virus) is an observational, multi-center study enrolling infants with severe RSV infection and healthy controls. Inclusion criteria are age below two years and hospitalization due to RSV infection at three German sites. Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or cardiac diseases, and immunodeficiency. Blood and respiratory specimens are collected upon admission, and RSV and other pathogens are analyzed by multiplex polymerase chain reaction (PCR). Further biomaterials including plasma, nasal lining fluid, blood cells, DNA, and RNA specimens are sampled in a dedicated biobank. Detailed information on demographic characteristics and medical history is recorded, as well as comprehensive clinical data including vital signs, medication, and interventions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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 Start

First participant enrolled

October 1, 2013

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

9.6 years

First QC Date

May 20, 2021

Last Update Submit

June 7, 2021

Conditions

Respiratory Syncytial Virus InfectionsRespiratory Syncytial Virus (RSV)Respiratory Syncytial Virus-bronchiolitis

Keywords

Respiratory Syncytial Virus (RSV)Infantsbronchiolitisinfectioncohort study

Outcome Measures

Primary Outcomes (1)

  • Incidence of severe RSV infection

    Number of patients with severe RSV infection in three tertiary care centers in northern Germany.

    5 years

Secondary Outcomes (1)

  • Outcome meassures of severe RSV infection in children (composite endpoint)

    5 years

Study Arms (1)

RSV Bronchiolitis Group

hospitalized children with confirmed RSV infection between the first month of life and second year of life

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study enrolls hospitalized children with confirmed RSV infection between the first month of life and second year of life. The diagnosis of RSV is evaluated by point-of-care testing, and positive findings are confirmed by polymerase chain reac-tion (PCR). Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or car-diac diseases, and immunodeficiency.

You may qualify if:

  • RSV Infection, confirmed by polymerase chain reaction (PCR)
  • Need for hospitalisation

You may not qualify if:

  • premature birth
  • bronchopulmonary diseases
  • cardiac diseases
  • immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Universitätsklinik für Kinder- und Jugendmedizin Oldenburg

Oldenburg, Lower Saxony, 26111, Germany

RECRUITING

Related Publications (1)

  • Wetzke M, Funken D, Lange M, Bejo L, Haid S, Monteiro JGT, Schutz K, Happle C, Schulz TF, Seidenberg J, Pietschmann T, Hansen G. IRIS: Infection with RespIratory Syncytial Virus in infants-a prospective observational cohort study. BMC Pulm Med. 2022 Mar 15;22(1):88. doi: 10.1186/s12890-022-01842-1.

    PMID: 35291998DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal aspirate or swab for PCR pathogen screening Nasal fluid EDTA whole blood Serum Plasma

MeSH Terms

Conditions

Respiratory Syncytial Virus InfectionsBronchiolitisInfections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesBronchitisRespiratory Tract InfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Hansen Gesine, Prof

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Wetzke, MD

CONTACT

0049 511 532 7436wetzke.martin@mh-hannover.de

Thomas Pietschmann, Prof

CONTACT

0049 511 532 7130pietschmann.thomas@mh-hannover.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

June 14, 2021

Study Start

October 1, 2013

Primary Completion

April 30, 2023

Study Completion

October 30, 2023

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations

DE(2)