TEFLARO ABSSSI Study Designs1,2
Type of trial:
Two identical randomized, multicenter, multinational, double-blind, noninferiority trials
1396 adults with clinically documented complicated skin and skin structure infection
TEFLARO — 600 mg administered IV over 1 hour every 12 hours for 5-14 days;
Vancomycin plus aztreonam — 1g vancomycin administered IV over 1 hour followed
by 1g aztreonam administered IV over 1 hour every 12 hours for 5-14 days
Treatment duration was 5 to 14 days. A switch to oral therapy was not allowed
TEFLARO Study Populations
Day 4 Population*
The analysis evaluated patients with lesion size ≥75 cm2 and having one of
the following infection types:
— Major abscess with ≥5 cm of surrounding erythema
— Wound infection
— Deep/extensive cellulitis
Test of Cure (TOC) Populations†
All randomized subjects who received any amount of study drug.
Patients in the MITT population who demonstrated sufficient adherence to the protocol.
Sufficient adherence is defined as patients who met the minimal clinical disease criteria
for cSSSI and all evaluability criteria, including subjects who received at least the
pre-specified minimal amount of the intended dose and duration of study drug therapy, for
which sufficient information regarding the cSSSI site is available to determine the subject's
outcome, and for which there were no confounding factors that interfered with the assessment
of that outcome.
This population consists of a subset of subjects from the CE population who had at least one
bacterial pathogen identified from a blood culture or culture of an adequate microbiological
sample obtained from the cSSSI site at the baseline and who had susceptibility testing
performed on at least one of the isolated baseline pathogens.