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

NCT00421304 | Completed Results DMC

• 1 other identifier: MI-CP141
• Study Type: interventional
• Target: 118
• Locations: 5 countries
• Sites: 35

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.

Conditions

RSV Illness in ≤12 Months of Participants

Keywords

Respiratory Syncytial Virus illness; RSV

Outcome Measures

Primary Outcomes (16)

• 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.

  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.

  Day 1

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

  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.

  Day 2

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

  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.

  Day 3

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

  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.

  Day 4

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

  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.

  Day 5

• RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6

  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.

  Day 6

• RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7

  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.

  Day 7

• RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30

  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.

  Day 30

• RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90

  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.

  Day 90

• RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180

  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.

  Day 180

• Motavizumab Concentration in Nasal Wash Aspirates at Day 0

  Motavizumab concentration in nasal wash aspirates is reported.

  Day 0

• Motavizumab Concentration in Nasal Wash Aspirates at Day 1

  Motavizumab concentration in nasal wash aspirates is reported.

  Day 1

• Motavizumab Concentration in Nasal Wash Aspirates at Day 2

  Motavizumab concentration in nasal wash aspirates is reported.

  Day 2

• Motavizumab Concentration in Nasal Wash Aspirates at Day 7

  Motavizumab concentration in nasal wash aspirates is reported.

  Day 7

• Motavizumab Concentration in Nasal Wash Aspirates at Day 30

  Motavizumab concentration in nasal wash aspirates is reported.

  Day 30

Secondary Outcomes (18)

• Duration of RSV Hospitalization

  From Randomization Day (Day 0) to Discharge Day (up to Day 30)

• Respiratory Assessment Change Score (RACS) Derived From Baseline

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

• Oxygen Saturation Level During RSV Hospitalization

  Days 0, 1, 2, 3, 7, and 30

• Heart Rate During RSV Hospitalization

  Days 0, 1, 2, 3, 7, and 30

• Respiratory Rate During RSV Hospitalization

  Days 0, 1, 2, 3, 7, and 30

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Motavizumab 30 mg/kg

EXPERIMENTAL

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

Biological: Motavizumab

Motavizumab 100 mg/kg

EXPERIMENTAL

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

Biological: Motavizumab

Interventions

Motavizumab BIOLOGICAL

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

Also known as: MEDI-524

Motavizumab 100 mg/kg; Motavizumab 30 mg/kg

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (35)

Research Site

Tucson, Arizona, 85724, United States

Location

Research Site

Long Beach, California, 90806, United States

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Research Site

Orange, California, 92868, United States

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San Diego, California, 92123, United States

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Jacksonville, Florida, United States

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Honolulu, Hawaii, 96826, United States

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Chicago, Illinois, 60612, United States

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Oak Lawn, Illinois, 60453, United States

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Boston, Massachusetts, 02111, United States

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Jackson, Mississippi, 39216-4505, United States

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Omaha, Nebraska, 68198, United States

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Brooklyn, New York, 11201, United States

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Buffalo, New York, 14222, United States

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Mineola, New York, 11501, United States

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New Hyde Park, New York, 11040, United States

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Rochester, New York, 14642, United States

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Syracuse, New York, 13210, United States

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Columbus, Ohio, 43205, United States

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Oklahoma City, Oklahoma, 73104-5066, United States

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Portland, Oregon, 97239, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77030, United States

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Salt Lake City, Utah, 84108, United States

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Seattle, Washington, 98105, United States

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Morgantown, West Virginia, 26506, United States

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Milwaukee, Wisconsin, 53226, United States

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Herston, 4029, Australia

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Independencia, Chile

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Santiago, 8360160, Chile

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Santiago, 8380418, Chile

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Santiago, Chile

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Auckland, 2025, New Zealand

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Hamilton, New Zealand

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Palmerston North, 5301, New Zealand

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Research Site

Panama City, Panama

Location

Related Publications (1)

• Ramilo O, Lagos R, Saez-Llorens X, Suzich J, Wang CK, Jensen KM, Harris BS, Losonsky GA, Griffin MP; Motavizumab Study Group. Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness. Pediatr Infect Dis J. 2014 Jul;33(7):703-9. doi: 10.1097/INF.0000000000000240.

  PMID: 24356256 DERIVED

MeSH Terms

Interventions

motavizumab

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca Clinical study Information Center

information.center@astrazeneca.com

+1-877-240-9479

Study Officials

• M. Pamela Griffin, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: January 10, 2007
• Primary Completion: September 17, 2009
• Study Completion: September 17, 2009
• Last Updated: August 27, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-07

Locations

US (26); NZ (3); PA (1); CL (4); AU (1)