Trial · NCT00129766
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of RSV Hospitalization (Includes Deaths by RSV) | Days 0 - 150 | RSV hospitalization was defined as 1) a respiratory hospitalization with a positive RSV test (primary), 2) a new onset of lower respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial), or 3) death demonstrated to have been caused by RSV (by autopsy or clinical history and virologic evidence). |
| Primary | Number of Participants Reporting Any Adverse Events (AEs) | Days 0 - 150 | Number of participants reporting one or more AEs |
| Primary | Number of Participants Reporting Any Related AEs | Days 0 - 150 | Number of participants reporting one or more AEs considered related to study drug by the investigator |
| Primary | Number of Participants Reporting Any Serious Adverse Events (SAEs) | Days 0 - 150 | Number of participants reporting one or more SAEs |
| Primary | Number of Participants Reporting Any Related SAEs | Days 0 - 150 | Number of participants reporting one or more SAEs considered related to study drug by the investigator |
| Primary | Number of Participants Reporting AEs by Highest Severity Grade | Days 0 - 150 | Adverse events events were graded by severity; Level 1, 2, 3, or 4 |
| Primary | Number of Participants Who Discontinued Study Drug Due to AEs | Days 0 - 150 | |
| Primary | Number of Participants Who Died | Days 0 - 150 | |
| Primary | Number of Participants Reporting Changes in Vital Signs From Baseline | Days 0 - 150 | Vital signs that were in a higher toxicity grade than observed at baseline were to be recorded as AEs |
| Secondary | The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI) | Day 0 - 150 | LRI was defined as an event of bronchiolitis or pneumonia or the occurance of a lower tract infectious illness as determined by the PI based on medical history, signs, and symptoms. |
| Secondary | The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups | Days 0 - 150 | The RSV-specific LRI was defined as an outpatient medically-attended LRI associated with a positive RSV test and was not inclusive of events that required hospitalization. |
| Secondary | The Incidence of Medically-attended Otitis Media (OM) Infections | Days 0 - 150 | Otitis media (OM) was to be recorded as the diagnosis if the following terms were used by the medical care provider: acute OM, acute tympanic membrane (TM) perforation, bulging TM, red TM with fever, OM with effusion, or middle ear effusion. A new episode was defined as a physician-diagnosed OM in either ear after a normal middle ear exam of the ear in question or an episode of acute OM greater than or equal to 21 days after resolution of the previous episode. A diagnosis of persistent middle ear effusion was not to be recorded as a new OM event. |
| Secondary | The Frequency of Prescribed Antibiotics for Medically-attended LRI | Days 0 - 150 | The average number of presciptions per event per subject was summarized for each treatment group. |
| Secondary | The Frequency of Prescribed Antibiotics for Medically-attended OM Infections | Days 0 - 150 | The average number of presciptions per event per subject was summarized for each treatment group. |
| Secondary | The Number of Participants With Anti-motavizumab Antibodies | Day 0 - 120 | Detection of anti-motavizumab antibodies was defined as a titer with a dilution value equal to or greater than 1:10. |
| Secondary | The Serum Concentrations of Motavizumab at Day 0 | Day 0 | Mean serum concentrations of motavizumab at Day 0 |
| Secondary | The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1 | 30 days post Dose 1 | Mean serum concentrations of motavizumab at 30 days post Dose 1 |
| Secondary | The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2 | 30 days post Dose 2 | Mean serum concentrations of motavizumab at 30 days post Dose 2 |
| Secondary | The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3 | 30 days post Dose 3 | Mean serum concentrations of motavizumab at 30 days post Dose 3 |
| Secondary | The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4 | 30 days post Dose 4 | Mean serum concentrations of motavizumab at 30 days post Dose 4 |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00129766/registered