The primary objective of the study is to show that in Chinese adults with CABP, a course of IV/PO treatment with omadacycline has similar clinical efficacy as the with the comparator antibiotic, IV/PO moxifloxacin. The study is designed as a bridging study, to confirm the results of the pivotal global CABP trial in an ethnically different population of Chinese.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Omadacycline IV/PO
Moxifloxacin IV/PO
Beijing Tsinghua Chang Gung Hospital/Infectious Diseases Department
Beijing, China
RECRUITINGPeking University Shougang Hospital/Respiratory and Critical Care Medicine Department
Beijing, China
RECRUITINGThe First Affiliated Hospital of Bengbu Medical College/Intensive care unit
Bengbu, China
RECRUITINGThe Central Hospital of Changsha/Department of Respiratory and Critical Care Medicine
Changsha, China
Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population.
Time frame: 18 months
Clinical response rate at the Early Clinical Response (ECR) assessment (72 to 120 hours after administration of the first dose of test article) in the mITT population.
Time frame: 72 to 120 hours
Clinical response rate at the End of Treatment (EOT) assessment in the mITT and CE population.
Time frame: 18 months
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The Third Hospital of Changsha/Respiratory and Critical Care Medicine Department
Changsha, China
RECRUITINGXiangya Hospital Central South University/Department of Respiratory and Critical Care Medicine
Changsha, China
RECRUITINGWest China Hospital of Sichuan University/Infectious Disease Center
Chengdu, China
RECRUITINGThe First People's Hospital of Foshan/Department of Respiratory and Critical Care Medicine
Foshan, China
RECRUITINGFuyang People's Hospital/Department of Respiratory and Critical Care Medicine
Fuyang, China
RECRUITINGThe First Affiliated Hospital of Gannan Medical University/Pneumology Department
Gannan, China
RECRUITING...and 30 more locations