"Palivizumab Therapy for RSV-bronchiolitis"

Sponsor

Hamad Medical Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT02442427

Collaborator

(none)

420

Enrollment

Location

Arms

Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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".

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus-bronchiolitis	Drug: Palivizumab Other: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

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)

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge [3 weeks]

Secondary Outcome Measures

Time to medical readiness for discharge [4 weeks]
Revisit to any medical facility for the same illness [4 weeks]
Admission to PICU during initial admission [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.