Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in CABP symptoms. Response is determined programmatically using investigator's assessment of the CABP symptoms. The severity of the participant's CABP symptoms was evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Subject Symptom Severity Guidance Framework for Investigator Assessment. An indeterminate response is defined as one that could not be adequately inferred because the participant was not assessed because they withdrew consent, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in 2CABP symptoms, worsening of CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event requiring alternative antibacterial treatment, or death

Time frame: 72 to 120 hours after the first dose of test article

Population: ITT population

At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred.

Time frame: 5 to 10 days after the last dose of test article

Population: ITT Population

At the PTE Visit, the investigator indicates one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred.

Time frame: 5 to 10 days after the last dose of test article

Population: CE-PTE Population consisted of all ITT participants who received test article, have a qualifying Community-Acquired Bacterial Pneumonia (CABP), an assessment of outcome, and meet all other evaluability criteria.