A study to investigate the effects of lumicitabine (JNJ-64041575) in hospitalized infants and children infected with Respiratory Syncytial Virus (RSV)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

• Male or female infants and children =28 days to =36 months of age, defined at the time of randomization.
• Subjects hospitalized (or in ER) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization.
• Subjects diagnosed with RSV infection using a PCR-based molecular diagnostic assay, with or without coinfection with another respiratory pathogen (respiratory virus or bacteria).
• Subjects who have an acute respiratory illness with signs and symptoms consistent with a viral infection (eg, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset =5 days from the anticipated time of randomization.
• With the exception of the symptoms related to the RSV infection or defined comorbid condition for severe RSV disease (prematurity at birth [subject’s gestational age was <37 weeks; for infants <1 year old at randomization], bronchopulmonary dysplasia,congenital heart disease, other congenital diseases, Down syndrome, neuromuscular impairment, or cystic fibrosis), subjects must be medically stable on the basis of physical examination, medical history, vital signs/SpO2, and ECG performed at screening.
• The subject’s estimated glomerular filtration rate (eGFR) is not below the lower limit of normal for the subject’s age (Schwartz equation calculation).
Are the trial subjects under 18? yes
Number of subjects for this age range: 180
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

• Subjects who are not expected to survive for more than 48 hours.
• Subjects who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization.
• Subjects who received (within 12 months prior to screening) or who are currently on a waiting list for a bone marrow, stem cell, or solid organ transplant, who received radiation or chemotherapy, or who are currently taking immunosuppressive medication.
• Subjects who have a known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as a known human immunodeficiency virus infection.
• Subjects who have a history of or concurrent illness (beyond a defined comorbid condition for severe RSV disease) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject, or that could prevent, limit, or confound the protocol-specified assessments.
• Subjects aged =28 days to 35 days with <8.0 g/dL (Grade 3) hemoglobin or a cardiac failure secondary to anemia (Grade 4) and subjects aged =36 days to 36 months with <7.0 g/dL (Grade 3) hemoglobin or cardiac failure secondary to anemia (Grade 4).
• Subjects aged =28 days to 60 days with <899/mm3 absolute neutrophil count) and subjects aged =61 days to =36 months with <399/mm3 absolute neutrophil count.
• Subjects aged =28 days to =36 months with <49,999/mm3 platelet count (Grade 3/4).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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