Trial · NCT00421304
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Day 0 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR 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. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 | Day 1 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 | Day 2 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3 | Day 3 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4 | Day 4 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5 | Day 5 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6 | Day 6 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7 | Day 7 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30 | Day 30 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90 | Day 90 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| Primary | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180 | Day 180 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| Primary | Motavizumab Concentration in Nasal Wash Aspirates at Day 0 | Day 0 | Motavizumab concentration in nasal wash aspirates is reported. |
| Primary | Motavizumab Concentration in Nasal Wash Aspirates at Day 1 | Day 1 | Motavizumab concentration in nasal wash aspirates is reported. |
| Primary | Motavizumab Concentration in Nasal Wash Aspirates at Day 2 | Day 2 | Motavizumab concentration in nasal wash aspirates is reported. |
| Primary | Motavizumab Concentration in Nasal Wash Aspirates at Day 7 | Day 7 | Motavizumab concentration in nasal wash aspirates is reported. |
| Primary | Motavizumab Concentration in Nasal Wash Aspirates at Day 30 | Day 30 | Motavizumab concentration in nasal wash aspirates is reported. |
| Secondary | Duration of RSV Hospitalization | From Randomization Day (Day 0) to Discharge Day (up to Day 30) | Duration of RSV hospitalization is reported. |
| Secondary | Respiratory Assessment Change Score (RACS) Derived From Baseline | Baseline (Day 0), Days 1, 2, 3, 7, and 30 | The RACS assesses changes in wheezing and retractions as measured by respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of less than or equal to (\<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration. |
| Secondary | Oxygen Saturation Level During RSV Hospitalization | Days 0, 1, 2, 3, 7, and 30 | Oxygen saturation level during RSV hospitalization is reported. |
| Secondary | Heart Rate During RSV Hospitalization | Days 0, 1, 2, 3, 7, and 30 | Heart rate during RSV hospitalization is reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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