Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus

Completed

• Conditions: Respiratory Tract Infections; Respiratory Syncytial Virus Infections
• Interventions: Other: RS-virus infection

• Registration Number: NCT03757429
• Lead Sponsor: Uppsala University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-29
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-RS-virus infection with mechanical ventilation	RS-virus infection	Patients admitted to the pediatric ICU due to a cause other than a verified or suspected respiratory tract infection.
RS-virus infection with mechanical ventilation	RS-virus infection	Patients admitted to the pediatric ICU with verified or suspected RS-virus infection that are mechanically ventilated.

Primary Outcome Measures

Name	Time	Method
Levels of inflammatory mediators in sputum	Up to three weeks	Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry
Levels of inflammatory mediators in blood	Up to three weeks	Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry
Levels of inflammatory mediators in urine	Up to three weeks	Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry

Secondary Outcome Measures

Name	Time	Method
Lung function as measured by spirometry	Within 10 years
Disease severity as measured by sequential organ failure assessment score (SOFA-score)	Up to 30-days
Lung function as measured in respirator	Up to 30-days

Trial Locations

Locations (1)

Akademiska sjukhuset, Centraloperation; 🇸🇪 Uppsala, Sweden