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細菌性肺炎患者におけるBAYQ3939の安全性、有効性、薬物動態/薬力学を評価する第III相試験

基本情報

NCT ID
NCT01561794
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
44
治験依頼者名
Bayer

概要

The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration \[MIC\] and Mutant Prevention Concentration \[MPC\]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in hospitalized patients with bacterial pneumonia or secondary infection of chronic respiratory disease with severe disease or a poor response to other antimicrobials. In addition, the efficacy of the ciprofloxacin, in terms of clinical response and microbiological response, will be investigated, but as a secondary endpoint.

対象疾患

Pneumonia

介入

Ciprofloxacin (Cipro, BAYQ3939)(DRUG)

依頼者(Sponsor)