Infection With Respiratory Syncytial Virus in Infants

Respiratory Syncytial Virus Infections Clinical Trial

— IRIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04925310
• Other study ID #: MHH6309
• Status: Recruiting
• Start date: October 1, 2013
• Est. completion date: October 30, 2023

Study information

• Verified date: June 2021
• Source: Hannover Medical School
• Contact: Martin Wetzke, MD
• Phone: 0049 511 532 7436
• Email: wetzke.martin[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 2 Years

Eligibility

Inclusion Criteria:

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

• Need for hospitalisation

Exclusion Criteria:

• premature birth

• bronchopulmonary diseases

• cardiac diseases

• immunodeficiency

Related Conditions & MeSH terms

• Bronchiolitis
• Communicable Diseases
• Infection
• Respiratory Syncytial Virus (RSV)
• Respiratory Syncytial Virus Infections
• Respiratory Syncytial Virus-bronchiolitis
• Virus Diseases

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hanover	Lower Saxony
Germany	Universitätsklinik für Kinder- und Jugendmedizin Oldenburg	Oldenburg	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe RSV infection	Number of patients with severe RSV infection in three tertiary care centers in northern Germany.	5 years
Secondary	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