allogene / autologe hematopoietische stamceltransplantaties RSV upper respiratory tract infections in HSCT patients / RSV upper airway infections in human stem cell transplant patients
Conditions
Interventions
Participants greater than or equal to (>=) 18 to less than or equal to (
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male or female - 18 to 75 years of age, inclusive - Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using any conditioning regimen - Absolute lymphocyte count (ALC) less than (=) 92 percent (%) on room air
Exclusion criteria
Exclusion criteria: - Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator - Requires supplemental oxygen at Screening or any time between Screening and randomization - Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus) within 7 days prior to or at the Screening visit, if determined by local SOC testing (additional testing is not required) - Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of JNJ 53718678 on the development of RSV lower tract respiratory infections (LRTIs) in adult hematopoietic stem cell transplant (HSCT) recipients with RSV upper respiratory tract infection (URTI), as measured by the proportion of participants who develop RSV LRTI (see definition below) per the Endpoint Adjudication Committee (EAC)*s assessment through Visit Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Participants who Develop RSV-associated Lower Respiratory Tract Complication (LRTC) Number of Participants with Adverse Events (AEs) Percentage of Participants with Abnormal Clinical Laboratory Findings Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings Percentage of Participants with Abnormal Vital Signs Findings Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC*s Assessment Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, (all-cause Mortality) Proportion of Participants Progressing to Death (All-cause Mortality), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC*s Assessment Proportion of Participants Progressing to Death (All-cause Mortality) Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC*s Assessment Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) Number of Supplemental Oxygen (O2) Free Days Incidence of Supplemental Oxygen Requirement Duration of Supplemental Oxygen Change from Baseline in Respiratory Rate Change from Baseline in Heart Rate Change from Baseline in Peripheral Capillary Oxygen Saturation (SpO2) Change from Baseline in Body Temperature Proportion of Participants Hospitalized (of Participants who Were not Hospitalized at Baseline) Proportion of Participants Re-hospitalized Total Length of Hospital Stay Total Time in the Intensive Care Unit (ICU) Incidence of Grade 3 and Grade 4 Adverse Events (AEs) Incidence of Respiratory AEs Incidence of | — |
Countries
Netherlands
Outcome results
None listed