Infection With Respiratory Syncytial Virus in Infants

NCT ID: NCT04925310

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-01
• Study Completion Date: 2023-10-30

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.

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.

Conditions

Respiratory Syncytial Virus Infections; Respiratory Syncytial Virus (RSV); Respiratory Syncytial Virus-bronchiolitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

RSV Bronchiolitis Group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• premature birth
• bronchopulmonary diseases
• cardiac diseases
• immunodeficiency

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hansen Gesine, Prof

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

Hannover Medical School

Hanover, Lower Saxony, Germany

Site Status: RECRUITING

Universitätsklinik für Kinder- und Jugendmedizin Oldenburg

Oldenburg, Lower Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Martin Wetzke, MD

Role: CONTACT

wetzke.martin@mh-hannover.de

0049 511 532 7436

Thomas Pietschmann, Prof

Role: CONTACT

pietschmann.thomas@mh-hannover.de

0049 511 532 7130

Facility Contacts

Martin Wetzke, MD

Role: primary

wetzke.martin@mh-hannover.de

0049 511 532 3220

Gesine Hansen, Prof

Role: backup

hansen.gesine@mh-hannover.de

0049 511 532 3220

Jürgen Seidenberg, Prof

Role: primary

seidenberg.juergen@klinikum-oldenburg.de

0049 441 798 3540

Mathias Lange, MD

Role: backup

Lange.Matthias@klinikum-oldenburg.de

0049 441 798 3540

References

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.

Reference Type: DERIVED

PMID: 35291998 (View on PubMed)

Other Identifiers

MHH6309

Identifier Type: -

Identifier Source: org_study_id