TEFLARO CABP Study Designs1,2
Type of trial:
Two randomized, multicenter, multinational, double-blind, noninferiority trials
1231 adults with a diagnosis of CABP
TEFLARO — 600 mg administered IV over 1 hour every 12 hours for 5-7 days; Ceftriaxone
— 1g ceftriaxone administered IV over 30 minutes every 24 hours for 5-7 days
CABP Trial 1, two doses on Day 1 of oral clarithromycin 500 mg every 12 hours; CABP Trial 2,
no adjunctive macrolide therapy
TEFLARO Study Populations
Day 4 Population (mITT)*
A microbiological intent-to-treat population (mITT population) containing only subjects
with a confirmed bacterial pathogen at baseline.
Test of Cure (TOC) Populations†
All randomized subjects who received any amount of study drug.
Modified Intent-to-treat Efficacy
All subjects in the MITT population who were in PORT Risk Class III or IV at baseline.
All subjects in the MITTE population who demonstrated sufficient adherence to the protocol.
Sufficient adherence is defined as patients who met the minimal disease criteria for CABP and
for whom sufficient information regarding the CABP was available to determine the patient's outcome.
All subjects in the CE population who had at least one typical bacterial pathogen identified
at baseline from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).