Infection With Respiratory Syncytial Virus in Infants (IRIS)

IRIS - Infection With Respiratory Syncytial Virus in Infants - a Prospective Observational Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus (RSV); Respiratory Syncytial Virus-bronchiolitis

Detailed Description

The IRIS study is designed as a multicentric, prospective, observational study initiated at Hannover Medical School, Germany. Upon enrollment, detailed data on demographic background, case histo-ry, clinical presentation, physical examination, diagnostic findings, treatment, and other patient related items is collected. Data on disease course, treatment, and complications is gathered. 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 (Hannover Unified Biobank). 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 (POCT, Sofia, Quidel, Kornwestheim, Germany), 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. Healthy control probands are enrolled via recruitment of patients undergoing routine surgical procedures. Written informed consent is obtained from all parents and caregivers. Three local study centers in northern Germany (Hannover, Oldenburg, and Hildesheim) are contributing. All study sites are secondary or tertiary care hospitals and undergo extensive training in recruitment, biosample acquisition and processing, data collection and data entry, logistics, and security.

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Martin Wetzke, MD; Phone Number: 0049 511 532 7436; Email: wetzke.martin@mh-hannover.de
• Study Contact Backup: Name: Thomas Pietschmann, Prof; Phone Number: 0049 511 532 7130; Email: pietschmann.thomas@mh-hannover.de

Study Locations

• Germany
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Recruiting
      • Hannover Medical School
      • Contact: Martin Wetzke, MD; Phone Number: 0049 511 532 3220; Email: wetzke.martin@mh-hannover.de
      • Contact: Gesine Hansen, Prof; Phone Number: 0049 511 532 3220; Email: hansen.gesine@mh-hannover.de
    • Oldenburg, Lower Saxony, Germany, 26111
      • Recruiting
      • Universitätsklinik für Kinder- und Jugendmedizin Oldenburg
      • Contact: Jürgen Seidenberg, Prof; Phone Number: 0049 441 798 3540; Email: seidenberg.juergen@klinikum-oldenburg.de
      • Contact: Mathias Lange, MD; Phone Number: 0049 441 798 3540; Email: Lange.Matthias@klinikum-oldenburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• premature birth
• bronchopulmonary diseases
• cardiac diseases
• immunodeficiency

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
RSV Bronchiolitis Group; hospitalized children with confirmed RSV infection between the first month of life and second year of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe RSV infection	Number of patients with severe RSV infection in three tertiary care centers in northern Germany.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome meassures of severe RSV infection in children (composite endpoint)	length of hospitalisation (days); length of additional oxygen supply (hours); number of patients with need for intensive care treatment; number of patients with need for invasive ventilation	5 years

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Hansen Gesine, Prof, Hannover Medical School

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: infection; cohort study; Respiratory Syncytial Virus (RSV); Infants; bronchiolitis
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Paramyxoviridae Infections; Mononegavirales Infections; Lung Diseases, Obstructive; Pneumovirus Infections; Bronchitis; Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections; Bronchiolitis
• Other Study ID Numbers: MHH6309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No