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Figure 1 | BMC Pulmonary Medicine

Figure 1

From: Efficacy and safety of tigecycline versus levofloxacin for community-acquired pneumonia

Figure 1

Flow diagram: disposition of patients. Patients randomized were included in the intent-to-treat (ITT) population. Those who received at least one dose of study drug comprised the modified ITT (mITT) population, and patients in the mITT population who had clinical evidence of CAP by meeting the minimal disease criteria made up the clinical modified ITT (c-mITT) population. The microbiologic modified intent-to-treat (m-mITT) population consisted of c-mITT subjects who had 1 or more baseline isolates identified. Patients in the c-mITT population were considered to be clinically evaluable (CE) if they satisfied inclusion and exclusion criteria, received no more than one dose of a non-once daily non-study antibacterial agent (single agent or combination therapy) to treat the current episode of CAP before the first dose of study drug, did not receive other concomitant systemic antimicrobial therapy unless a treatment failure, received at least 2 full days of study drug if clinical failure or 5 full days of study drug if clinical cure, were adherent with therapy (i.e., ≥ 80% but ≤ 120% of medication administered), had an assessment of cure or failure at the test-of-cure visit (10-21 days after the last dose of therapy), and the study blind was maintained. The microbiologically evaluable (ME) population included CE patients for whom at least one isolate was identified from the baseline culture that was susceptible to both test drugs and who had a microbiologic response that could be classified as eradication, persistence, or superinfection at the test-of-cure visit.

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