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

Sponsored by:	MedImmune LLC
Information provided by:	MedImmune LLC
ClinicalTrials.gov Identifier:	NCT00435227

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 II

Drug Information available for: MEDI-524

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Safety/Efficacy Study
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

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
1: Experimental MEDI-524	Biological: MEDI-524 30 mg/kg of MEDI-524
2: Placebo Comparator 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:	MedImmune Inc. ( M. Pamela Griffin, M.D )
Study ID Numbers:	MI-CP146
Study First Received:	February 13, 2007
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00435227 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by MedImmune LLC:

Respiratory Syncytial Viruses

Study placed in the following topic categories:

Antibodies, Monoclonal
Virus Diseases
Antibodies
Healthy
Immunoglobulins

ClinicalTrials.gov processed this record on May 07, 2009