N/A
N=118
A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
RSV Illness in ≤12 Months of Participants
Bottom Line
View on ClinicalTrials.gov: NCT00421304 ↗Enrolled (actual)
118
Serious AEs
16.8%
Results posted
Aug 2021
Primary outcome: Primary: 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 — 8.13; 8.05; 8.15 log10 copies/mL — p=0.218
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motavizumab (Biological); Placebo (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
8.13; 8.05; 8.15 | 0.218 |
| PRIMARY RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 |
7.61; 7.54; 7.40 | 0.257 |
| PRIMARY RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 |
6.95; 6.68; 6.59 | 0.591 |
| PRIMARY RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3 |
6.12; 6.11; 5.95 | 0.894 |
| PRIMARY RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4 |
6.00; 5.76; 5.41 | 0.397 |
| PRIMARY RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5 |
5.52; 5.26; 5.31 | 0.322 |
| PRIMARY RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6 |
5.63; 5.25; 5.60 | 0.847 |
| PRIMARY RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7 |
4.86; 4.73; 4.52 | 0.653 |
| PRIMARY RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30 |
3.03; 3.05; 2.96 | 0.988 |
| PRIMARY RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90 |
2.66; 2.55; 2.50 | 0.280 |
| PRIMARY RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180 |
2.68; 2.52; 2.50 | 0.742 |
| PRIMARY Motavizumab Concentration in Nasal Wash Aspirates at Day 0 |
0.93; 0.00 | 1.000 |
| PRIMARY Motavizumab Concentration in Nasal Wash Aspirates at Day 1 |
4673.3; 10087 | 0.050 |
| PRIMARY Motavizumab Concentration in Nasal Wash Aspirates at Day 2 |
2341.2; 7436.7 | 0.008 sig |
| PRIMARY Motavizumab Concentration in Nasal Wash Aspirates at Day 7 |
966.37; 2464.2 | 0.012 sig |
| PRIMARY Motavizumab Concentration in Nasal Wash Aspirates at Day 30 |
431.21; 1934.5 | <0.001 sig |
| SECONDARY Duration of RSV Hospitalization |
3.55; 3.98; 4.46 | — |
| SECONDARY Respiratory Assessment Change Score (RACS) Derived From Baseline |
-1.81; -1.36; -2.11; -2.14; -3.51; -3.61 | — |
| SECONDARY Oxygen Saturation Level During RSV Hospitalization |
96.8; 97.5; 97.1; 97.3; 98.1; 97.2 | — |
| SECONDARY Heart Rate During RSV Hospitalization |
148.6; 155.6; 157.6; 146.0; 145.9; 145.9 | — |
| SECONDARY Respiratory Rate During RSV Hospitalization |
46.86; 49.28; 51.78; 44.35; 48.67; 48.00 | — |
| SECONDARY Number of Participants With Supplemental Oxygen Use During RSV Hospitalization |
24; 30; 29 | — |
| SECONDARY Duration of Supplemental Oxygen Use During RSV Hospitalization |
3.5; 4.1; 4.4 | — |
| SECONDARY Number of Participants on Mechanical Ventilation During RSV Hospitalization |
0; 2; 2 | — |
| SECONDARY Duration of Mechanical Ventilation During RSV Hospitalization |
7.81; 4.64 | — |
| SECONDARY Number of Participants Admitted to the Intensive Care Unit (ICU) |
0; 3; 3 | — |
| SECONDARY Duration of ICU Stay During RSV Hospitalization |
7.3; 5.0 | — |
| SECONDARY Number of Participants With Medically-attended Wheezing Episodes |
2; 0; 2; 19; 20; 18 | — |
| SECONDARY Serum Concentration of Motavizumab |
298.73; 863.05; 192.87; 640.36; 11.39; 30.81 | — |
| SECONDARY Number of Participants With Detectable Anti-motavizumab Antibodies |
1; 1; 11; 10; 21; 14 | — |
| SECONDARY Change From Baseline in Serum Cytokine Levels |
-3.005; 0.48; 48.943; -266.925; -107.834; -171.278 | — |
| SECONDARY Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels |
-2607.852; -2575.906; -1772.376; -91761.764; -97050.821; -69391.250 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
33; 28; 32; 6; 6; 7 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs |
0; 1; 0; 0; 0; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00421304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.