Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
MI-CP141
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
RSV Illness in =12 Months of Participants
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - 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.
Other interventions: 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.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
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
Query!
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.
Query!
Timepoint [1]
0
0
Day 0
Query!
Primary outcome [2]
0
0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1
Query!
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.
Query!
Timepoint [2]
0
0
Day 1
Query!
Primary outcome [3]
0
0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2
Query!
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.
Query!
Timepoint [3]
0
0
Day 2
Query!
Primary outcome [4]
0
0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3
Query!
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.
Query!
Timepoint [4]
0
0
Day 3
Query!
Primary outcome [5]
0
0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4
Query!
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.
Query!
Timepoint [5]
0
0
Day 4
Query!
Primary outcome [6]
0
0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5
Query!
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.
Query!
Timepoint [6]
0
0
Day 5
Query!
Primary outcome [7]
0
0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6
Query!
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.
Query!
Timepoint [7]
0
0
Day 6
Query!
Primary outcome [8]
0
0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7
Query!
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.
Query!
Timepoint [8]
0
0
Day 7
Query!
Primary outcome [9]
0
0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30
Query!
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.
Query!
Timepoint [9]
0
0
Day 30
Query!
Primary outcome [10]
0
0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90
Query!
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.
Query!
Timepoint [10]
0
0
Day 90
Query!
Primary outcome [11]
0
0
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180
Query!
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.
Query!
Timepoint [11]
0
0
Day 180
Query!
Primary outcome [12]
0
0
Motavizumab Concentration in Nasal Wash Aspirates at Day 0
Query!
Assessment method [12]
0
0
Motavizumab concentration in nasal wash aspirates is reported.
Query!
Timepoint [12]
0
0
Day 0
Query!
Primary outcome [13]
0
0
Motavizumab Concentration in Nasal Wash Aspirates at Day 1
Query!
Assessment method [13]
0
0
Motavizumab concentration in nasal wash aspirates is reported.
Query!
Timepoint [13]
0
0
Day 1
Query!
Primary outcome [14]
0
0
Motavizumab Concentration in Nasal Wash Aspirates at Day 2
Query!
Assessment method [14]
0
0
Motavizumab concentration in nasal wash aspirates is reported.
Query!
Timepoint [14]
0
0
Day 2
Query!
Primary outcome [15]
0
0
Motavizumab Concentration in Nasal Wash Aspirates at Day 7
Query!
Assessment method [15]
0
0
Motavizumab concentration in nasal wash aspirates is reported.
Query!
Timepoint [15]
0
0
Day 7
Query!
Primary outcome [16]
0
0
Motavizumab Concentration in Nasal Wash Aspirates at Day 30
Query!
Assessment method [16]
0
0
Motavizumab concentration in nasal wash aspirates is reported.
Query!
Timepoint [16]
0
0
Day 30
Query!
Secondary outcome [1]
0
0
Duration of RSV Hospitalization
Query!
Assessment method [1]
0
0
Duration of RSV hospitalization is reported.
Query!
Timepoint [1]
0
0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Query!
Secondary outcome [2]
0
0
Respiratory Assessment Change Score (RACS) Derived From Baseline
Query!
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.
Query!
Timepoint [2]
0
0
Baseline (Day 0), Days 1, 2, 3, 7, and 30
Query!
Secondary outcome [3]
0
0
Oxygen Saturation Level During RSV Hospitalization
Query!
Assessment method [3]
0
0
Oxygen saturation level during RSV hospitalization is reported.
Query!
Timepoint [3]
0
0
Days 0, 1, 2, 3, 7, and 30
Query!
Secondary outcome [4]
0
0
Heart Rate During RSV Hospitalization
Query!
Assessment method [4]
0
0
Heart rate during RSV hospitalization is reported.
Query!
Timepoint [4]
0
0
Days 0, 1, 2, 3, 7, and 30
Query!
Secondary outcome [5]
0
0
Respiratory Rate During RSV Hospitalization
Query!
Assessment method [5]
0
0
Respiratory rate during RSV hospitalization is reported.
Query!
Timepoint [5]
0
0
Days 0, 1, 2, 3, 7, and 30
Query!
Secondary outcome [6]
0
0
Number of Participants With Supplemental Oxygen Use During RSV Hospitalization
Query!
Assessment method [6]
0
0
Number of participants with supplemental oxygen use during RSV hospitalization is reported.
Query!
Timepoint [6]
0
0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Query!
Secondary outcome [7]
0
0
Duration of Supplemental Oxygen Use During RSV Hospitalization
Query!
Assessment method [7]
0
0
Duration of supplemental oxygen use during RSV hospitalization is reported.
Query!
Timepoint [7]
0
0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Query!
Secondary outcome [8]
0
0
Number of Participants on Mechanical Ventilation During RSV Hospitalization
Query!
Assessment method [8]
0
0
Number of participants on mechanical ventilation during RSV hospitalization is reported.
Query!
Timepoint [8]
0
0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Query!
Secondary outcome [9]
0
0
Duration of Mechanical Ventilation During RSV Hospitalization
Query!
Assessment method [9]
0
0
Duration of mechanical ventilation during RSV hospitalization is reported.
Query!
Timepoint [9]
0
0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Query!
Secondary outcome [10]
0
0
Number of Participants Admitted to the Intensive Care Unit (ICU)
Query!
Assessment method [10]
0
0
Number of participants admitted to ICU is reported.
Query!
Timepoint [10]
0
0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Query!
Secondary outcome [11]
0
0
Duration of ICU Stay During RSV Hospitalization
Query!
Assessment method [11]
0
0
Duration of ICU stay during RSV hospitalization is reported.
Query!
Timepoint [11]
0
0
From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Query!
Secondary outcome [12]
0
0
Number of Participants With Medically-attended Wheezing Episodes
Query!
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.
Query!
Timepoint [12]
0
0
From randomization (Day 0) through Day 360 (approximately 12 months)
Query!
Secondary outcome [13]
0
0
Serum Concentration of Motavizumab
Query!
Assessment method [13]
0
0
Motavizumab concentration in serum is reported.
Query!
Timepoint [13]
0
0
Days 1, 7, 90, 180, and 360
Query!
Secondary outcome [14]
0
0
Number of Participants With Detectable Anti-motavizumab Antibodies
Query!
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.
Query!
Timepoint [14]
0
0
Days 0, 180, and 360
Query!
Secondary outcome [15]
0
0
Change From Baseline in Serum Cytokine Levels
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
Baseline (Day 0, pre-dose) through Day 360
Query!
Secondary outcome [16]
0
0
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels
Query!
Assessment method [16]
0
0
Change from baseline in upper respiratory tract (nasal wash) cytokine levels are reported.
Query!
Timepoint [16]
0
0
Baseline (Day 0, pre-dose) through Day 180
Query!
Secondary outcome [17]
0
0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Query!
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.
Query!
Timepoint [17]
0
0
From the start of study drug (Day 0) through Day 90
Query!
Secondary outcome [18]
0
0
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Query!
Assessment method [18]
0
0
Query!
Timepoint [18]
0
0
From the start of study drug (Day 0) through Day 30
Query!
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
Query!
Minimum age
0
Months
Query!
Query!
Maximum age
12
Months
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/01/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
17/09/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
118
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Herston
Query!
Recruitment postcode(s) [1]
0
0
4029 - Herston
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Hawaii
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Massachusetts
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Mississippi
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Nebraska
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Ohio
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Oklahoma
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Oregon
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Utah
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Washington
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
West Virginia
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Wisconsin
Query!
Country [18]
0
0
Chile
Query!
State/province [18]
0
0
Independencia
Query!
Country [19]
0
0
Chile
Query!
State/province [19]
0
0
Santiago
Query!
Country [20]
0
0
New Zealand
Query!
State/province [20]
0
0
Auckland
Query!
Country [21]
0
0
New Zealand
Query!
State/province [21]
0
0
Hamilton
Query!
Country [22]
0
0
New Zealand
Query!
State/province [22]
0
0
Palmerston North
Query!
Country [23]
0
0
Panama
Query!
State/province [23]
0
0
Ciudad de Panama
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
MedImmune LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00421304
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
M. Pamela Griffin, M.D.
Query!
Address
0
0
MedImmune LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00421304
Download to PDF