"Palivizumab Therapy for RSV-bronchiolitis"

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

There is a growing body of literature suggesting that monoclonal antibody could be efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically insignificant adverse effects.

"The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in diagnosed infants <3 months old with RSV bronchiolitis will result in fewer infants with readmissions to infirmary/observation or hospital for relapse during 3 weeks of follow-up after discharge".

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Antibodies; Antibodies, Monoclonal; Palivizumab

Criteria

Inclusion Criteria:

• Infants ≤ 3 months-old, presenting to the main pediatric ER with acute bronchiolitis associated with positive RSV rapid antigen test.

Exclusion Criteria:

• Patients will be excluded from the study if they had 1 or more of the following characteristics:

• Received monoclonal antibody or IVIG within the last 3 months prior to randomization.

• Receipt of steroids within 2 days before randomization.

• Hypersensitivity to monoclonal antibodies or immunoglobulin products.

• Immunodeficiency.

• Suspected sepsis.

• Seizure disorders.

• Neuromuscular disorders.

• Congenital heart disease.

• Major congenital anomalies of respiratory tract.