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CLINICAL STUDIES

Non-comparative Trials

In the non-comparative trials, patients often presented with multiple co-morbidities and/or physiologic impairments, and may have been intolerant to or failed other antibacterial therapies.

Vancomycin-Resistant Enterococcus faecium

Results are available from four non-comparative studies of Synercid (7.5 mg/kg q.h. for the treatment of vancomycin-resistant Enterococcus faecium (VREF) (N=1222). Three of these studies were prospective, the fourth consisted of a collection of individual emergency-use requests.

Of the 1,222 patients, 27% did not have a specific site of infection identified, but presented with proof growth of VREF in two or more blood cultures. Ninety percent (90%) of these patients had clearance of their VREF bacteremia within the first 48 to 72 hours of therapy.

Because of the emergency use nature of the VREF trials and the variability in data collection in these severely ill patients, the percentage of patients found to be evaluable was 24.4%. The overall efficacy rate (defined as clinical success and eradication of the initial pathogen) in the evaluable patients (n=298) was 52.3%. The most common sites of infection included intra-abdominal, skin and skin structure, and the urinary tract. In these subgroups, the efficacy rates for the evaluable patients having the most complete documentation were 46.3% (n=67), 66.7% (n=15), and 73.9% (n=23), respectively.

The most common adverse reactions considered related to Synercid use were myalgias and arthralgias. (See ADVERSE REACTIONS.) All-cause mortality in the 4 studies ranged from 49.5% to 54.0%.

COMPARATIVE TRIALS

Complicated Skin and Skin Structure Infections

Two randomized, open-label, controlled clinical trials of Synercid (7.5 mg/kg q12h intravenously [iv]) in the treatment of complicated skin and skin structure infections were performed. The comparator drug was oxacillin (2g q6h iv) in the first study (JRV 304) and cefazolin (1g q8h iv) in the second study (JRV 305); however, in both studies vancomycin (1g q12h iv) could be substituted for the specified comparator if the causative pathogen was suspected or confirmed methicillin-resistant staphylococcus or if the patient was allergic to penicillins, cephalosporins or carbapenems. Study JRV 304 enrolled 450 patients (n = 229 Synercid; n= 221 Comparator) and Study JRV 305 enrolled 443 patients (n = 221 Synercid; n = 222 Comparator).

In the first study, 105 patients (45.9%) and 106 patients (48.0%) in the Synercid and Comparator arms, respectively, were found to be clinically evaluable. For the second study, these values were 113 (51.1%) and 120 (54.1%) patients in the Synercid and Comparator arms, respectively. Patients were found not to be clinically evaluable for reasons such as: wrong diagnosis, lower extremity infection in patients with diabetes or peripheral vascular disease since these infections were assumed to include aerobic gram-negative and anaerobic organisms, no specimen for culture obtained, insufficient therapy, no test of cure assessment, etc.

For the patients found to be clinically evaluable, in Study JRV 304 the success rate was 49.5% in the Synercid arm and 51.9% in the Comparator arm. In Study JRV 305, the success rates were 66.4% and 64.2% in the Synercid and Comparator arms, respectively.

The following table shows the clinical success rate (combined results from two clinical trials) in the clinically evaluable population. Due to the small numbers of patients in the subsets, statistical conclusions could not be reached.

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