Respiratory Syncytial Virus Infections Clinical Trial
— IRISOfficial title:
IRIS - Infection With Respiratory Syncytial Virus in Infants - a Prospective Observational Cohort Study
NCT number | NCT04925310 |
Other study ID # | MHH6309 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2013 |
Est. completion date | October 30, 2023 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Hannover Medical School | Hanover | Lower Saxony |
Germany | Universitätsklinik für Kinder- und Jugendmedizin Oldenburg | Oldenburg | Lower Saxony |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School |
Germany,
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 |
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