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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00435227
First received: February 13, 2007
Last updated: July 2, 2012
Last verified: July 2012
  Purpose
  • The purpose of this study is to describe the effect of a single (IM) dose of motavizumab in the upper respiratory tract in children who present with RSV illness but who do not require hospitalization at the time of presentation and
  • Describe the effect of a single 30 mg/kg IM dose of motavizumab in decreasing the need for hospitalization due to worsening RSV illness in children who receive outpatient treatment
  • Describe the effect of a single 30 mg/kg IM dose of motavizumab on subsequent respiratory status as measured by the Respiratory Assessment Change Score (RACS) and change in oxygen saturation
  • For children who require hospitalization, describe the effect of motavizumab on severity of RSV illness during hospitalization [i.e., RACS, oxygen saturation, heart rate, use of supplemental oxygen, mechanical ventilation, and duration of intensive care unit (ICU) stay]
  • Describe the effect of a single 30 mg/kg IM dose of motavizumab on duration of symptoms of RSV illness (fever, coryza, cough, and parental opinion of return to normal health and activity)
  • Describe the nasal concentration of motavizumab following a single 30mg/kg dose
  • Describe the serum pharmacokinetics and immunogenicity of a single 30 mg/kg IM dose of motavizumab
  • Describe the effect of motavizumab on markers of inflammation as measured by gene microarray and cytokine levels
  • Evaluate the safety and tolerability of a single 30 mg/kg IM dose of motavizumab in the outpatient treatment of children with RSV
  • Describe the progression and severity of lower respiratory infection (LRI)

Condition Intervention Phase
Healthy
Biological: MEDI-524
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intramuscular Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Outpatient Treatment of Children With RSV Illness

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • The specific measure will be to determine viral load in the upper respiratory tract in children with RSV infection by comparing mean RT-PCR val. over time between treatment groups [ Time Frame: Days, 0,2,8-29 (if hospitalized), 30 & 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • For children with RSV illness; a) the change in RACS from baseline at randomization; b) the change in oxygen saturation over time [ Time Frame: Through Day 30 ] [ Designated as safety issue: No ]
  • Percentage of children who have progression of RSV illness that requires subsequent hospitalization. [ Time Frame: Through Day 30 ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: March 2007
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MEDI-524
Biological: MEDI-524
30 mg/kg of MEDI-524
Other Name: Motivizumab
Placebo Comparator: 2
Placebo
Other: Placebo
30 mg/kg of Placebo

Detailed Description:

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg 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.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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/min in children < 2 months and < 50 breaths/min 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 patient's parent(s) or legal guardian

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435227

  Show 24 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: M. Pamela Griffin, M.D. MedImmune LLC
  More Information

No publications provided

Responsible Party: M. Pamela Griffin, M.D, MedImmune Inc.
ClinicalTrials.gov Identifier: NCT00435227     History of Changes
Other Study ID Numbers: MI-CP146
Study First Received: February 13, 2007
Last Updated: July 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Respiratory Syncytial Viruses

ClinicalTrials.gov processed this record on April 15, 2014