A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness

NCT00435227 | Terminated Phase 2 Results DMC

• 1 other identifier: MI-CP146
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 31

Brief Summary

This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization. Using 1:1 randomization, 30 mg/kg motavizumab or placebo will be administered as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study has been confirmed.

Conditions

Participants Less Than 12 Months of Age With RSV Illness

Keywords

Respiratory Syncytial Viruses; RSV

Outcome Measures

Primary Outcomes (4)

• Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract of RSV-infected Participants as Measured by Reverse Transcriptase-polymerase Chain Reaction (RT-PCR) at Day 0

  The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.

  Day 0

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

  The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.

  Day 2

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

  The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.

  Day 30

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

  The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.

  Day 90

Secondary Outcomes (18)

• Percentage of Participants Who Have Progression of RSV Illness That Requires Subsequent Hospitalization

  From Randomiation (Day 0) Up to Day 30

• Respiratory Assessment Change Score (RACS) Derived From Baseline

  Baseline (Day 0); and Days 2, 7, and 30

• Change From Baseline in Oxygen Saturation Level

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

• Change in RACS of RSV-infected Outpatient Participants Who Subsequently Required Hospitalization

  Baseline (Day 0) to Day 30

• Oxygen Saturation Levels in RSV-infected Outpatient Participants Who Subsequently Required Hospitalization

  Baseline (Day 0) to Day 30

Study Arms (2)

Motavizumab

EXPERIMENTAL

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

Biological: Motavizumab

Placebo

PLACEBO COMPARATOR

Participants will receive a single IM dose of placebo matched to motavizumab on Day 0 of the study.

Other: Placebo

Interventions

Motavizumab BIOLOGICAL

A single IM dose of 30 mg/kg will be administered on Day 0 of the study.

Also known as: MEDI-524

Motavizumab

Placebo OTHER

A single IM 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:

• Previously healthy
• Age ≤12 months at the time of randomization
• Weight ≤10 kg at the time of randomization
• Gestational age ≥36 weeks
• RSV illness (must have coryza) documented by a positive RSV test at the time of evaluation
• Documented stable clinical condition that does not require hospitalization (oxygen saturation ≥ 95%; respiratory rate \< 60 breaths/minute in children \< 2 months and \< 50 breaths/minute in children 2-12 months)
• Respiratory Distress Assessment Instrument (RDAI) score of ≤ 6 (there can be no more than 1 point assigned for each of the 6 assessment categories) at baseline evaluation
• Randomization within 4 hours of being evaluated with a positive Binax® RSV test
• Written informed consent obtained from the participant's parent(s) or legal guardian

You may not qualify if:

• Prior receipt of or receiving treatment with steroids (except topical steroids) prior to randomization
• Prior medically diagnosed RSV infection
• Prior receipt of or receiving anti-viral treatment for the current episode of RSV infection prior to randomization
• Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than the acute RSV infection
• Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
• Requirement for supplemental oxygen (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 \[children with medically or surgically closed patent ductus arteriosus (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed\]
• Previous reaction to intravenous immunoglobulin (IVIG), blood products, or other foreign proteins
• Prior use of IVIG, RSV-IGIV (RespiGam®), motavizumab or other immunoglobulin products within the past 2 months
• Prior use of palivizumab (Synagis®) within the past 2 months
• Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
• Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (31)

Research Site

Tucson, Arizona, United States

Location

Research Site

Jonesboro, Arkansas, 72401, United States

Location

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Jonesboro, Arkansas, United States

Location

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Little Rock, Arkansas, 72202, United States

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Little Rock, Arkansas, United States

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Orange, California, 92868, United States

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San Diego, California, 92103, United States

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Miami, Florida, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30342, United States

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Augusta, Georgia, 30912, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, 02111, United States

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Detroit, Michigan, 48201, United States

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Las Vegas, Nevada, 89107, United States

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Paterson, New Jersey, 07503, United States

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Brooklyn, New York, 11203-2098, United States

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Buffalo, New York, 14222-2099, United States

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The Bronx, New York, United States

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Youngstown, Ohio, 44051, United States

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Oklahoma City, Oklahoma, 73104, United States

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Nashville, Tennessee, 37232-2581, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77030, United States

Location

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Richmond, Virginia, 23298, United States

Location

West Virginia University Pediactric Center

Charleston, West Virginia, 25302, United States

Location

Research Site

Charleston, West Virginia, 72205, United States

Location

Research Site

Huntington, West Virginia, 25701-3655, United States

Location

Research Site

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Interventions

motavizumab

Limitations and Caveats

On 21Feb2008, the study was terminated earlier than planned completion time due to an inability to enroll planned number of participants. Due to low enrollment, the data for outcome measure of "Duration of symptoms of RSV illness" was not collected.

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: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 14, 2007
• Study Start: March 20, 2007
• Primary Completion: May 31, 2008
• Study Completion: May 31, 2008
• Last Updated: August 17, 2021
• Results First Posted: August 17, 2021

Record last verified: 2021-07

Locations

US (31)