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"Palivizumab Therapy for RSV-bronchiolitis"

This study is currently recruiting participants.
Verified May 2016 by Hamad Medical Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02442427
First Posted: May 13, 2015
Last Update Posted: August 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hamad Medical Corporation
  Purpose

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".


Condition Intervention Phase
Respiratory Syncytial Virus-bronchiolitis Drug: Palivizumab Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Respiratory Syncytial Virus Bronchiolitis in Young Infants With Humanized Monoclonal Antibody: A Randomized Clinical Trial (Palivizumab Study)

Resource links provided by NLM:


Further study details as provided by Hamad Medical Corporation:

Primary Outcome Measures:
  • Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • Time to medical readiness for discharge [ Time Frame: 4 weeks ]
  • Revisit to any medical facility for the same illness [ Time Frame: 4 weeks ]
  • Admission to PICU during initial admission [ Time Frame: 4 weeks ]

Estimated Enrollment: 420
Study Start Date: September 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Monoclonal antibody
Placebo Comparator: Placebo
An equivalent volume of 0.9% normal saline.
Other: Placebo
An equal volume of 0.9% normal saline
Other Name: 0.9% Normal saline

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442427


Contacts
Contact: Dr. Khalid Alansari 55336166 kalansari1@hmc.org.qa
Contact: Dr. Fatihi Toaimah 55628623 fsoliman2@yahoo.com

Locations
Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar, 3050
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
Principal Investigator: Dr. Khalid Alansari Hamad Medical Corporation, Doha, Qatar
  More Information

Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT02442427     History of Changes
Other Study ID Numbers: 14302/14
First Submitted: May 10, 2015
First Posted: May 13, 2015
Last Update Posted: August 30, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hamad Medical Corporation:
Respiratory syncytial virus
Palivizumab
Bronchiolitis
Treatment

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Antibodies
Antibodies, Monoclonal
Palivizumab
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents


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