"Palivizumab Therapy for RSV-bronchiolitis"

February 26, 2018 updated by: Hamad Medical Corporation

Treatment of Respiratory Syncytial Virus Bronchiolitis in Young Infants With Humanized Monoclonal Antibody: A Randomized Clinical Trial (Palivizumab Study)

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Setting:

The study will be conducted between September 2014 and April 2018 in the short stay unit of the Pediatric Emergency Center (PEC) of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. The PEC serves an average of 280 000 patients annually and manages 42 beds in a short stay infirmary unit, to which patients are admitted if they are too ill to be sent home but do not need the intensive care unit. Patients admitted to the unit are assessed at least every 6 hours by a pediatrician to determine readiness for discharge. The length of stay in the unit for bronchiolitis ranges from 6 to 168 hours. In 2012, the investigators saw 8718 infants and young children in 10 666 visits for bronchiolitis. Infants aged ≤3 months presenting to the unit for treatment of viral bronchiolitis will be eligible for the study. Consecutive patients will be recruited except when a study nurse is unavailable or the unit is too busy to recruit.

Procedure:

Patients will be examined on presentation, and those needing additional treatment or observation will be admitted to the short stay infirmary unit. Consecutive patients with bronchiolitis will be assessed for study eligibility within 2 hours. Eligible patients will be enrolled after obtaining written consent. For those who consent, plain chest radiography, and nasopharyngeal swabs will be taken for RSV detection. If the patient has a positive RSV rapid antigen test, patients will be randomized to receive one of the study arms. Bronchiolitis severity score will be measured initially at the start of treatment and then at 12-hour, 24-hour, 36-hour and 48-hour thereafter. The medical team in addition to the parents and patients will be blinded to the medication delivered. Adverse effects in each group will be carefully monitored and documented. Patients will be sent home with salbutamol metered-dose inhalers with an appropriately sized Aerochamber with mask attachment. Daily follow-up by study nurse by telephone is mandatory for 1 week after discharge and then once a week for 2 weeks thereafter. The patient could return to the pediatric emergency center earlier if needed. At all revisits for the same illness, nasopharyngeal swabs will be taken for RSV rapid antigen test and the result recorded.

Study Intervention:

  • Active arm: A single dose of IV palivizumab 15 mg per kilogram body weight (maximum dose =100 mg).
  • Control arm: Placebo (an equivalent volume of 0.9% normal saline).

Study Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar, 3050
        • Hamad Medical Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Palivizumab
A single dose of IV palivizumab
Drug: Palivizumab
A single dose of IV palivizumab 15 mg per kilogram body weight (maximum dose =100 mg). The study medication will be given by IV infusion over 30 minutes using a syringe infusion pump.
Other Names:
  • Monoclonal antibody
Placebo Comparator: Placebo
An equivalent volume of 0.9% normal saline.
Other: Placebo
An equal volume of 0.9% normal saline
Other Names:
  • 0.9% Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to medical readiness for discharge
Time Frame: 4 weeks
4 weeks
Revisit to any medical facility for the same illness
Time Frame: 4 weeks
4 weeks
Admission to PICU during initial admission
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Investigators

  • Principal Investigator: Dr. Khalid Alansari, Hamad Medical Corporation, Doha, Qatar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

May 10, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Actual)

February 27, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14302/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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