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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
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
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
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
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
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
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
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
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
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
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
Timepoint [11] 0 0
Day 180
Primary outcome [12] 0 0
Motavizumab Concentration in Nasal Wash Aspirates at Day 0
Timepoint [12] 0 0
Day 0
Primary outcome [13] 0 0
Motavizumab Concentration in Nasal Wash Aspirates at Day 1
Timepoint [13] 0 0
Day 1
Primary outcome [14] 0 0
Motavizumab Concentration in Nasal Wash Aspirates at Day 2
Timepoint [14] 0 0
Day 2
Primary outcome [15] 0 0
Motavizumab Concentration in Nasal Wash Aspirates at Day 7
Timepoint [15] 0 0
Day 7
Primary outcome [16] 0 0
Motavizumab Concentration in Nasal Wash Aspirates at Day 30
Timepoint [16] 0 0
Day 30
Secondary outcome [1] 0 0
Duration of RSV Hospitalization
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
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
Timepoint [3] 0 0
Days 0, 1, 2, 3, 7, and 30
Secondary outcome [4] 0 0
Heart Rate During RSV Hospitalization
Timepoint [4] 0 0
Days 0, 1, 2, 3, 7, and 30
Secondary outcome [5] 0 0
Respiratory Rate During RSV Hospitalization
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
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
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
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
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)
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
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
Timepoint [12] 0 0
From randomization (Day 0) through Day 360 (approximately 12 months)
Secondary outcome [13] 0 0
Serum Concentration of Motavizumab
Timepoint [13] 0 0
Days 1, 7, 90, 180, and 360
Secondary outcome [14] 0 0
Number of Participants With Detectable Anti-motavizumab Antibodies
Timepoint [14] 0 0
Days 0, 180, and 360
Secondary outcome [15] 0 0
Change From Baseline in Serum Cytokine Levels
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
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)
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
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
Address
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 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