RSウイルス感染症による肺炎を患う乳幼児における、血液中の試験薬(シスナトビル)の量と安全性を調べる研究
基本情報
- NCT ID
- NCT06102174
- ステータス
- 中止
- 試験のフェーズ
- 第1相
- 試験タイプ
- 介入
- 目標被験者数
- 10
- 治験依頼者名
- Pfizer
概要
The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months. These children have Lower Respiratory Tract Infection (LRTI) caused by Respiratory Syncytial Virus (RSV). LRTI is the infection to the lower airways such as lungs. This study will help inform the amount of sisunatovir to be used in future studies of sisunatovir in children. This study is seeking for participants who: * Are 1 day to less than or equal to 60 months of age * weigh more than or equal to 2.5 kilograms to less than or equal to 23 kilograms. * Have been tested to have RSV by medical tests. * show signs of LRTI. All participants in the study will receive many amounts of sisunatovir or placebo. Placebo is a pill that does not have any medicine in it. Up to 7 visits are required for the study. Some of these visits include checking participants health over the phone and/or a visit at home. The study will compare the experiences of infants and children receiving sisunatovir to identify the amount of sisunatovir to be used in future studies in infants and children.
対象疾患
介入
依頼者(Sponsor)
実施施設 (4)
地方独立行政法人山梨県立病院機構 山梨県立中央病院
Kofu, Yamanashi, Japan
大同病院
Nagoya, Aichi-ken, Japan
大阪市立総合医療センター
Osaka, Japan
Nintenkai Kagoshima Children's Hospital
Hioki, Kagoshima-ken, Japan