A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory S… (NCT03959488) | Clinical Trial Compass
CompletedPhase 2/3
A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children
United States925 participantsStarted 2019-07-30
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.
Who can participate
Age range0 Years – 1 Year
SexALL
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Inclusion criteria
✓. For the preterm cohort (excluding subjects with CLD or hemodynamically significant CHD): preterm infants in their first year of life and born ≤ 35 weeks 0 days GA eligible to receive palivizumab in accordance with national or local guidelines, including those with:
✓. Uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus, or
✓. Aortic stenosis, pulmonic stenosis, or coarctation of the aorta alone
✓. For the CLD/CHD cohort:
✓. Subjects with CLD - infants in their first year of life and a diagnosis of CLD of prematurity requiring medical intervention/management (ie, supplemental oxygen, bronchodilators, or diuretics) within the 6 months prior to randomization
✓. Subjects with CHD - infants in their first year of life and documented, hemodynamically significant CHD (must be unoperated or partially corrected CHD) Note: Infants with hemodynamically significant acyanotic cardiac lesions must have pulmonary hypertension (≥ 40 mmHg measured pressure in the pulmonary artery) or the need for daily medication to manage CHD
✓. Infants who are entering their first RSV season at the time of screening
✓. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA, EU Data Privacy Directive in the EU) obtained from the subject's parent(s)/legal representative(s) prior to performing any protocol-related procedures, including screening evaluations
Exclusion criteria
✕. Any fever (≥ 100.4°F \[≥ 38.0°C\], regardless of route) or acute illness within 7 days prior to randomization
What they're measuring
1
Safety and Tolerability of MEDI8897 as Assessed by the Occurrence of All Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) and New Onset Chronic Disease (NOCD)
✕. Any history of LRTI or active LRTI prior to, or at the time of, randomization
✕. Known history of RSV infection or active RSV infection prior to, or at the time of, randomization
✕. Hospitalization at the time of randomization, unless discharge is expected within the 7 days after randomization
✕. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, CPAP, or other mechanical respiratory or cardiac support at the time of randomization
✕. Anticipated cardiac surgery within 2 weeks after randomization
✕. Anticipated survival of \< 6 months after randomization