ABSSSI Patient Demographics and Study Design
These hypothetical case studies present examples of types of patients who may benefit from TEFLARO.
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 3 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.
NOTE: BMI, body mass index (calculated as the weight in kilograms divided by the square of
height in meters); SD, standard deviation.
*Includes patients with surgical procedures performed <24 hours before first dose or randomization
and <48 hours after first dose.
Adapted from Corey GR et al. Clin Infect Dis. 2010. Reproduced with permission of the Infectious
Diseases Society of America.
*TEFLARO is indicated for ABSSSI due to MRSA. It is not indicated for CABP due to MRSA.
MSSA=Methicillin-susceptible Staphylococcus aureus.
MRSA=Methicillin-resistant Staphylococcus aureus.
*There are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at a TOC time point.
Etest® is a registered trademark of BioMérieux
§MSSA=Methicillin-susceptible Staphylococcus aureus.
Clinical efficacy of TEFLARO in treating CABP due to MRSA has not been studied.