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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014