Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus

Respiratory Tract Infections Clinical Trial

— IMAR  

Official title:

Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757429
• Other study ID #: 2017-515IMAR
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2022
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Infection with human respiratory syncytial (RS) virus is the most common cause of hospital stay due to pediatric lower respiratory tract infection. An exaggerated immune response contributes to the pathogenesis and small children may have over reactive airways for a long time after an infection. New research has shown that polymorphonuclear leukocytes (PMNs) are stimulated by the virus. Besides fighting the infection they also cause collateral damage to the host. Among other mechanisms PMNs stimulates mucus formation that affects breathing. They also secrete enzymes, toxic proteins and free radicals that may cause harm to lung tissue and airways. The current project strives towards identifying and quantifying inflammatory mediators in sputum, urine and blood of children with severe RS-virus infection. The ultimate aim of the project is to, in detail, describe proteins contributing to the pathogenesis of the disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Admission to pediatric intensive care unit
• Clinical need for invasive ventilation
• Clinical need for intravascular catheterization
• Clinical need for urine bladder catheterization
• Patients with verified or suspected RS-virus-infection or no respiratory tract infection (control group)

Exclusion Criteria:

• Chronic inflammatory lung disease

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Syncytial Virus Infections
• Respiratory Tract Infections

Intervention

Other:
• RS-virus infection
The intervention consists of lower respiratory tract infection due to RS-virus

Locations

Country	Name	City	State
Sweden	Akademiska sjukhuset, Centraloperation	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Swedish University of Agricultural Sciences

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of inflammatory mediators in sputum	Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry	Up to three weeks
Primary	Levels of inflammatory mediators in blood	Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry	Up to three weeks
Primary	Levels of inflammatory mediators in urine	Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry	Up to three weeks
Secondary	Disease severity as measured by sequential organ failure assessment score (SOFA-score)		Up to 30-days
Secondary	Lung function as measured in respirator		Up to 30-days
Secondary	Lung function as measured by spirometry		Within 1 year
Secondary	Lung function as measured by spirometry		Within 10 years