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Infection With Respiratory Syncytial Virus in Infants

NCT04925310 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2021-06-14

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Hansen Gesine, Prof · Hannover Medical School

Eligibility

Min Age
1 Month
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-01
Primary Completion
2023-04-30
Completion
2023-10-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04925310 on ClinicalTrials.gov