NCT02442427

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 27, 2018

Status Verified

January 1, 2018

Enrollment Period

3.4 years

First QC Date

May 10, 2015

Last Update Submit

February 26, 2018

Conditions

Respiratory Syncytial Virus-bronchiolitis

Keywords

Respiratory syncytial virusPalivizumabBronchiolitisTreatment

Outcome Measures

Primary Outcomes (1)

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

    3 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

Palivizumab

ACTIVE COMPARATOR

A single dose of IV palivizumab

Drug: Palivizumab

Placebo

PLACEBO COMPARATOR

An equivalent volume of 0.9% normal saline.

Other: Placebo

Interventions

PalivizumabDRUG

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.

Also known as: Monoclonal antibody
Palivizumab
PlaceboOTHER

An equal volume of 0.9% normal saline

Also known as: 0.9% Normal saline
Placebo

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

Location

Related Publications (1)

  • Alansari K, Toaimah FH, Almatar DH, El Tatawy LA, Davidson BL, Qusad MIM. Monoclonal Antibody Treatment of RSV Bronchiolitis in Young Infants: A Randomized Trial. Pediatrics. 2019 Mar;143(3):e20182308. doi: 10.1542/peds.2018-2308. Epub 2019 Feb 13.

    PMID: 30760509DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

PalivizumabAntibodies, MonoclonalSaline Solution

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Dr. Khalid Alansari

    Hamad Medical Corporation, Doha, Qatar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2015

First Posted

May 13, 2015

Study Start

September 1, 2014

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 27, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

QA(1)