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薬剤耐性肺結核の治療におけるクアボデピスタット含有レジメンの研究

基本情報

NCT ID
NCT07209761
ステータス
募集中
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
532
治験依頼者名
Otsuka Pharmaceutical Development & Commercialization, Inc.

概要

This study aims to assess quabodepistat-based treatment regimens for RR/MDR-TB. The study will enroll adults and adolescents with rifampicin-resistant or multidrug-resistant pulmonary TB. The main goal is to see if a new drug called quabodepistat, when combined with other TB drugs, can shorten treatment duration to 4 months and be as effective and safer than current WHO endorsed treatment regimen given for 6-months. The study will compare different drug combinations in two groups of patients: those whose TB is sensitive to fluoroquinolones and those whose TB is resistant to fluoroquinolones. Participants will be randomly assigned to receive either the new treatment or the standard treatment. The study will last for 16 months for each participant and will measure how well the treatments work and how safe they are.

対象疾患

Pulmonary Tuberculosis

介入

BPaQM(DRUG)
BPaLM(DRUG)
BPaQ(DRUG)
BPaL(DRUG)

依頼者(Sponsor)

実施施設 (1)

公益財団法人結核予防会 複十字病院

Kiyose, Tokyo, Japan(NOT_YET_RECRUITING)