A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness

MedImmune

Status: Completed

Conditions: RSV Illness in ≤12 Months of Participants

Treatments: Biological: Motavizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00421304

MI-CP141

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study.

Treatment:

Other: Placebo

Motavizumab 30 mg/kg

Experimental group

Description:

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

Treatment:

Biological: Motavizumab

Motavizumab 100 mg/kg

Experimental group

Description:

Participants will receive a single IV dose of motavizumab 100 mg/kg on Day 0 of the study.

Treatment:

Biological: Motavizumab