How effective is Synercid for different infections?
Seven phase III development studies of quinupristin/dalfopristin (Synercid) sponsored by the drug's manufacturer, Rhone-Poulenc Rorer in Collegeville, PA, examined the efficacy of the new drug for these three indications:
· nosocomial pneumonia;
· community-acquired pneumonia (CAP);
· complicated skin and skin-structure infection (C-SSSI).
In addition, an emergency-use program (EUP) was conducted, mostly for patients with vancomycin-resistant Enterococcus faecium (VREF) infection.
A regimen of 7.5 mg/kg of quinupristin/ dalfopristin every 12 hours was administered to CAP and C-SSSI patients. Patients with nosocomial pneumonia and in the EUP received 7.5 mg/kg of the drug every eight hours.
Quinupristin/dalfopristin was compared to vancomycin in patients with nosocomial pneumonia; it was compared to ceftriaxone plus erythromycin in CAP patients; and it was compared to vancomycin or oxacillin/cefazoline for C-SSSI patients.
The efficacy of quinupristin/dalfopristin in patients with a positive blood culture at study entry in each indication is shown in the accompanying table (see chart, p. 57) as the "Bacteriologic Response Rate." Please note that there is a "N/A" comparator bacteriologic response for EUP and VREF patients because they had resistant infections, and there were no other antimicrobial agents available to treat them.