Clinical trial NCT00421304: A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate a Single Intravenous Dose of Motavizumab (MEDI-524), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), for the Treatment of Children Hospitalized With RSV Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: RSV Illness in ≤12 Months of Participants
Keywords: Respiratory Syncytial Virus illness
RSV
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 118
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The primary objective of this study is to describe the effect of a single 30 mg/kg or 100 mg/kg intravenous (IV) dose of Motavizumab compared to placebo on study drug levels and viral load as measured by cultivatable virus and real-time reverse transcriptase-polymerase chain reaction (RT-PCR) in the upper respiratory tract in previously healthy children ≤12 months of age who are hospitalized with lower respiratory tract illness.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: Day 0
measure: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1
timeFrame: Day 1
measure: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2
timeFrame: Day 2
measure: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3
timeFrame: Day 3
measure: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4
timeFrame: Day 4
measure: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5
timeFrame: Day 5
measure: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6
timeFrame: Day 6
measure: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7
timeFrame: Day 7
measure: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30
timeFrame: Day 30
measure: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90
timeFrame: Day 90
measure: RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180
timeFrame: Day 180
measure: Motavizumab Concentration in Nasal Wash Aspirates at Day 0
timeFrame: Day 0
measure: Motavizumab Concentration in Nasal Wash Aspirates at Day 1
timeFrame: Day 1
measure: Motavizumab Concentration in Nasal Wash Aspirates at Day 2
timeFrame: Day 2
measure: Motavizumab Concentration in Nasal Wash Aspirates at Day 7
timeFrame: Day 7
measure: Motavizumab Concentration in Nasal Wash Aspirates at Day 30
timeFrame: Day 30
Secondary outcomes:
measure: Duration of RSV Hospitalization
timeFrame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
measure: Respiratory Assessment Change Score (RACS) Derived From Baseline
timeFrame: Baseline (Day 0), Days 1, 2, 3, 7, and 30
measure: Oxygen Saturation Level During RSV Hospitalization
timeFrame: Days 0, 1, 2, 3, 7, and 30
measure: Heart Rate During RSV Hospitalization
timeFrame: Days 0, 1, 2, 3, 7, and 30
measure: Respiratory Rate During RSV Hospitalization
timeFrame: Days 0, 1, 2, 3, 7, and 30
measure: Number of Participants With Supplemental Oxygen Use During RSV Hospitalization
timeFrame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
measure: Duration of Supplemental Oxygen Use During RSV Hospitalization
timeFrame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
measure: Number of Participants on Mechanical Ventilation During RSV Hospitalization
timeFrame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
measure: Duration of Mechanical Ventilation During RSV Hospitalization
timeFrame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
measure: Number of Participants Admitted to the Intensive Care Unit (ICU)
timeFrame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
measure: Duration of ICU Stay During RSV Hospitalization
timeFrame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
measure: Number of Participants With Medically-attended Wheezing Episodes
timeFrame: From randomization (Day 0) through Day 360 (approximately 12 months)
measure: Serum Concentration of Motavizumab
timeFrame: Days 1, 7, 90, 180, and 360
measure: Number of Participants With Detectable Anti-motavizumab Antibodies
timeFrame: Days 0, 180, and 360
measure: Change From Baseline in Serum Cytokine Levels
timeFrame: Baseline (Day 0, pre-dose) through Day 360
measure: Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels
timeFrame: Baseline (Day 0, pre-dose) through Day 180
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From the start of study drug (Day 0) through Day 90
measure: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
timeFrame: From the start of study drug (Day 0) through Day 30
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Long Beach
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Oak Lawn
country: United States
facility: Research Site
state: Illinois
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Jackson
country: United States
facility: Research Site
state: Mississippi
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Mineola
country: United States
facility: Research Site
state: New York
city: New Hyde Park
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Syracuse
country: United States
facility: Research Site
state: New York
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Herston
country: Australia
facility: Research Site
city: Independencia
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Auckland
country: New Zealand
facility: Research Site
city: Hamilton
country: New Zealand
facility: Research Site
city: Palmerston North
country: New Zealand
facility: Research Site
city: Ciudad de Panama
country: Panama
facility: Research Site
Study officials:
affiliation: MedImmune LLC
name: M. Pamela Griffin, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.