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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00421304




Registration number
NCT00421304
Ethics application status
Date submitted
9/01/2007
Date registered
11/01/2007
Date last updated
27/08/2021

Titles & IDs
Public title
A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness
Secondary ID [1] 0 0
MI-CP141
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
RSV Illness in =12 Months of Participants 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Motavizumab
Other interventions - Placebo

Placebo comparator: Placebo - Participants will receive a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.

Experimental: Motavizumab 30 mg/kg - Participants will receive a single IV dose of motavizumab 30 mg/kg on Day 0 of the study.

Experimental: Motavizumab 100 mg/kg - Participants will receive a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.


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

Other interventions: Placebo
A single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Assessment method [1] 0 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.
Timepoint [1] 0 0
Day 0
Primary outcome [2] 0 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Day 1
Primary outcome [3] 0 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Day 2
Primary outcome [4] 0 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Day 3
Primary outcome [5] 0 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Day 4
Primary outcome [6] 0 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Day 5
Primary outcome [7] 0 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Day 6
Primary outcome [8] 0 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
Day 7
Primary outcome [9] 0 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
Day 30
Primary outcome [10] 0 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
Day 90
Primary outcome [11] 0 0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
Day 180
Primary outcome [12] 0 0
Motavizumab Concentration in Nasal Wash Aspirates at Day 0
Assessment method [12] 0 0
Motavizumab concentration in nasal wash aspirates is reported.
Timepoint [12] 0 0
Day 0
Primary outcome [13] 0 0
Motavizumab Concentration in Nasal Wash Aspirates at Day 1
Assessment method [13] 0 0
Motavizumab concentration in nasal wash aspirates is reported.
Timepoint [13] 0 0
Day 1
Primary outcome [14] 0 0
Motavizumab Concentration in Nasal Wash Aspirates at Day 2
Assessment method [14] 0 0
Motavizumab concentration in nasal wash aspirates is reported.
Timepoint [14] 0 0
Day 2
Primary outcome [15] 0 0
Motavizumab Concentration in Nasal Wash Aspirates at Day 7
Assessment method [15] 0 0
Motavizumab concentration in nasal wash aspirates is reported.
Timepoint [15] 0 0
Day 7
Primary outcome [16] 0 0
Motavizumab Concentration in Nasal Wash Aspirates at Day 30
Assessment method [16] 0 0
Motavizumab concentration in nasal wash aspirates is reported.
Timepoint [16] 0 0
Day 30
Secondary outcome [1] 0 0
Duration of RSV Hospitalization
Assessment method [1] 0 0
Duration of RSV hospitalization is reported.
Timepoint [1] 0 0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Secondary outcome [2] 0 0
Respiratory Assessment Change Score (RACS) Derived From Baseline
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Baseline (Day 0), Days 1, 2, 3, 7, and 30
Secondary outcome [3] 0 0
Oxygen Saturation Level During RSV Hospitalization
Assessment method [3] 0 0
Oxygen saturation level during RSV hospitalization is reported.
Timepoint [3] 0 0
Days 0, 1, 2, 3, 7, and 30
Secondary outcome [4] 0 0
Heart Rate During RSV Hospitalization
Assessment method [4] 0 0
Heart rate during RSV hospitalization is reported.
Timepoint [4] 0 0
Days 0, 1, 2, 3, 7, and 30
Secondary outcome [5] 0 0
Respiratory Rate During RSV Hospitalization
Assessment method [5] 0 0
Respiratory rate during RSV hospitalization is reported.
Timepoint [5] 0 0
Days 0, 1, 2, 3, 7, and 30
Secondary outcome [6] 0 0
Number of Participants With Supplemental Oxygen Use During RSV Hospitalization
Assessment method [6] 0 0
Number of participants with supplemental oxygen use during RSV hospitalization is reported.
Timepoint [6] 0 0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Secondary outcome [7] 0 0
Duration of Supplemental Oxygen Use During RSV Hospitalization
Assessment method [7] 0 0
Duration of supplemental oxygen use during RSV hospitalization is reported.
Timepoint [7] 0 0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Secondary outcome [8] 0 0
Number of Participants on Mechanical Ventilation During RSV Hospitalization
Assessment method [8] 0 0
Number of participants on mechanical ventilation during RSV hospitalization is reported.
Timepoint [8] 0 0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Secondary outcome [9] 0 0
Duration of Mechanical Ventilation During RSV Hospitalization
Assessment method [9] 0 0
Duration of mechanical ventilation during RSV hospitalization is reported.
Timepoint [9] 0 0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Secondary outcome [10] 0 0
Number of Participants Admitted to the Intensive Care Unit (ICU)
Assessment method [10] 0 0
Number of participants admitted to ICU is reported.
Timepoint [10] 0 0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Secondary outcome [11] 0 0
Duration of ICU Stay During RSV Hospitalization
Assessment method [11] 0 0
Duration of ICU stay during RSV hospitalization is reported.
Timepoint [11] 0 0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Secondary outcome [12] 0 0
Number of Participants With Medically-attended Wheezing Episodes
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
From randomization (Day 0) through Day 360 (approximately 12 months)
Secondary outcome [13] 0 0
Serum Concentration of Motavizumab
Assessment method [13] 0 0
Motavizumab concentration in serum is reported.
Timepoint [13] 0 0
Days 1, 7, 90, 180, and 360
Secondary outcome [14] 0 0
Number of Participants With Detectable Anti-motavizumab Antibodies
Assessment method [14] 0 0
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.
Timepoint [14] 0 0
Days 0, 180, and 360
Secondary outcome [15] 0 0
Change From Baseline in Serum Cytokine Levels
Assessment method [15] 0 0
Timepoint [15] 0 0
Baseline (Day 0, pre-dose) through Day 360
Secondary outcome [16] 0 0
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels
Assessment method [16] 0 0
Change from baseline in upper respiratory tract (nasal wash) cytokine levels are reported.
Timepoint [16] 0 0
Baseline (Day 0, pre-dose) through Day 180
Secondary outcome [17] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Assessment method [17] 0 0
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.
Timepoint [17] 0 0
From the start of study drug (Day 0) through Day 90
Secondary outcome [18] 0 0
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Assessment method [18] 0 0
Timepoint [18] 0 0
From the start of study drug (Day 0) through Day 30

Eligibility
Key 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
Minimum age
0 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/09/2009
Sample size
Target
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Hawaii
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
United States of America
State/province [16] 0 0
West Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Chile
State/province [18] 0 0
Independencia
Country [19] 0 0
Chile
State/province [19] 0 0
Santiago
Country [20] 0 0
New Zealand
State/province [20] 0 0
Auckland
Country [21] 0 0
New Zealand
State/province [21] 0 0
Hamilton
Country [22] 0 0
New Zealand
State/province [22] 0 0
Palmerston North
Country [23] 0 0
Panama
State/province [23] 0 0
Ciudad de Panama

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedImmune LLC
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
M. Pamela Griffin, M.D.
Address 0 0
MedImmune LLC
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00421304