A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness

MedImmune LLC118 enrolled

Overview

The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.

The primary objective of this study is to describe the effect of a single 30 mg/kg or 100 mg/kg intravenous (IV) dose of Motavizumab compared to placebo on study drug levels and viral load as measured by cultivatable virus and real-time reverse transcriptase-polymerase chain reaction (RT-PCR) in the upper respiratory tract in previously healthy children ≤12 months of age who are hospitalized with lower respiratory tract illness.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

118

Conditions

RSV Illness in ≤12 Months of Participants

Interventions

MotavizumabBIOLOGICAL

A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study.

PlaceboOTHER

A single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 12 Months

Medical Language ↔ Plain English

Inclusion Criteria: Children must meet all of the following criteria: * Previously healthy * Age less or equal to 12 months at the time of randomization * Gestational age more or equal to 36 weeks * Hospitalized for lower respiratory tract illness (i.e., RSV bronchiolitis and/or pneumonia) * Documented positive RSV test within 48 hours prior to randomization * Randomization within 12 hours of the decision to hospitalize a child for RSV illness * Written informed consent obtained from the participant's parent(s)/legal guardian Exclusion Criteria: Children must have none of the following: * Prior receipt of or receiving ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization * Any use of systemic or inhaled steroids within the past 30 days prior to randomization * Intubation for ventilatory support at randomization * Any medically significant underlying ongoing chronic illness or organ system dysfunction, or other known acute illness except for RSV infection * Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency * Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed) * Mechanical ventilation at any time prior to the onset of the current RSV infection * Congenital heart disease \[children with medically or surgically closed patent ductus arteriosis (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed\] * Previous reaction to IVIG, blood products, or other foreign proteins * Prior use of intravenous immunoglobulin (IVIG), palivizumab (SynagisÒ), or other immunoglobulin products within the past 2 months * Currently receiving other investigational agents or have received any other investigational agents within the 3 months prior to randomization * Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV

Locations (35)

Outcomes

Primary Outcomes

Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children less than or equal to (\<=12) months of age who are hospitalized with lower respiratory tract illness.

Time frame: Day 0

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1

The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.

Time frame: Day 1

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2

Time frame: Day 2

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3

Time frame: Day 3

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4

Time frame: Day 4

RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Duration of RSV Hospitalization

Duration of RSV hospitalization is reported.

Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)

Respiratory Assessment Change Score (RACS) Derived From Baseline

The RACS assesses changes in wheezing and retractions as measured by respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of less than or equal to (\<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration.

Time frame: Baseline (Day 0), Days 1, 2, 3, 7, and 30

Oxygen Saturation Level During RSV Hospitalization

Oxygen saturation level during RSV hospitalization is reported.

Time frame: Days 0, 1, 2, 3, 7, and 30

Heart Rate During RSV Hospitalization

Heart rate during RSV hospitalization is reported.

Time frame: Days 0, 1, 2, 3, 7, and 30

Respiratory Rate During RSV Hospitalization

Respiratory rate during RSV hospitalization is reported.

Time frame: Days 0, 1, 2, 3, 7, and 30

Number of Participants With Supplemental Oxygen Use During RSV Hospitalization

Number of participants with supplemental oxygen use during RSV hospitalization is reported.

Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)

Duration of Supplemental Oxygen Use During RSV Hospitalization

Duration of supplemental oxygen use during RSV hospitalization is reported.

Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)

Number of Participants on Mechanical Ventilation During RSV Hospitalization

Number of participants on mechanical ventilation during RSV hospitalization is reported.

Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)

Duration of Mechanical Ventilation During RSV Hospitalization

Duration of mechanical ventilation during RSV hospitalization is reported.

Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)

Number of Participants Admitted to the Intensive Care Unit (ICU)

Number of participants admitted to ICU is reported.

Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)

Duration of ICU Stay During RSV Hospitalization

Duration of ICU stay during RSV hospitalization is reported.

Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)

Number of Participants With Medically-attended Wheezing Episodes

Wheezing episodes are considered medically-attended wheezing episodes if the medical care provider verifies and documents wheezing in the medical record or, in the case of hospitalization, the medical care provider assigns a discharge diagnosis of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode is the one that occurs for more than 2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Medically-attended wheezing episodes were calculated and reported in the range of 0 to 9 events.

Time frame: From randomization (Day 0) through Day 360 (approximately 12 months)

Serum Concentration of Motavizumab

Motavizumab concentration in serum is reported.

Time frame: Days 1, 7, 90, 180, and 360

Number of Participants With Detectable Anti-motavizumab Antibodies

Number of participants with detectable anti-motavizumab antibodies are reported. Detection is defined as an anti-motavizumab antibody titer with a dilution value of 1:30 or greater.

Time frame: Days 0, 180, and 360

Change From Baseline in Serum Cytokine Levels

Time frame: Baseline (Day 0, pre-dose) through Day 360

Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels

Change from baseline in upper respiratory tract (nasal wash) cytokine levels are reported.

Time frame: Baseline (Day 0, pre-dose) through Day 180

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Time frame: From the start of study drug (Day 0) through Day 90

Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs

Time frame: From the start of study drug (Day 0) through Day 30