Respiratory syncytial virus infection MedDRA version: 20.0 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female infants and children who were previously randomized in Study 64041575RSV2004 for the treatment of RSV infection and who completed the planned course of the study drug and the last study-related visit of Study 64041575RSV2004. 2. The subject’s legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing for the subject to participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 63 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject’s legally acceptable representative, ie, parent/legal guardian/caregiver, is not able to maintain reliable communication with the investigator. 2. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to evaluate in infants and children who have been treated with lumicitabine or placebo in Study 64041575RSV2004 during the follow-up period and within 2 years after the RSV infection: • The incidence of the clinical diagnosis of asthma. • The frequency of wheezing. ;Secondary Objective: The secondary objectives are to evaluate during the follow-up period in infants and children who have been treated with lumicitabine or placebo in Study 64041575RSV2004: • The frequency of wheezing over time. • The frequency of wheezing episodes over time. • The long-term safety of lumicitabine. • The frequency and type of respiratory infections. • Medical resource utilization.;Primary end point(s): • Clinical diagnosis of asthma within the first 2 years after the RSV infection, as diagnosed by a physician and reported by the parent/caregiver. • Percentage of wheezing days within the first 2 years after the RSV infection, based on information reported by the parent/caregiver.;Timepoint(s) of evaluation of this end point: Monitored throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of wheezing days per month after the RSV infection, based on information reported by the parent/caregiver. • Number of wheezing episodes after the RSV infection, based on information reported by the parent/caregiver. • Incidence of reportable AEs and SAEs among subjects, based on information reported by the parent/caregiver and judged by the investigator. Reportable AEs include AEs related to respiratory illnesses and AEs considered at least possibly related to lumicitabine or placebo by the investigator. • Number and type of respiratory infections among subjects, based on information reported by the parent/caregiver. • Medical resource utilization including the number of medical visits, emergency room visits, and hospitalizations, all for respiratory conditions only, based on information reported by the parent/caregiver.;Timepoint(s) of evaluation of this end point: Monitored throughout the study | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, New Zealand, Panama, Poland, Portugal, Slovakia, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed