Daptomycin (Page 8 of 10)

14 CLINICAL TRIALS

14.1 Complicated Skin and Skin Structure Infections

Adults with cSSSI

Adult patients with clinically documented complicated skin and skin structure infections (cSSSI) (Table 15) were enrolled in two randomized, multinational, multicenter, investigator-blinded trials comparing Daptomycin for Injection (4 mg/kg IV q24h) with either vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g IV per day). Patients could switch to oral therapy after a minimum of 4 days of IV treatment if clinical improvement was demonstrated. Patients known to have bacteremia at baseline were excluded. Patients with creatinine clearance (CLCR ) between 30 and 70 mL/min were to receive a lower dose of Daptomycin for Injection as specified in the protocol; however, the majority of patients in this subpopulation did not have the dose of Daptomycin for Injection adjusted.

Table 15: Investigator’s Primary Diagnosis in the cSSSI Trials in Adult Patients (Population: ITT)
*
Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses).
The majority of cases were subsequently categorized as complicated cellulitis, major abscesses, or traumatic wound infections.

Primary Diagnosis

Adult Patients (Daptomycin for Injection / Comparator * )

Study 9801

N=264 / N=266

Study 9901

N=270 / N=292

Pooled

N=534 / N=558

Wound Infection

99 (38%) / 116 (44%)

102 (38%) / 108 (37%)

201 (38%) / 224 (40%)

Major Abscess

55 (21%) / 43 (16%)

59 (22%) / 65 (22%)

114 (21%) / 108 (19%)

Ulcer Infection

71 (27%) / 75 (28%)

53 (20%) / 68 (23%)

124 (23%) / 143 (26%)

Other Infection

39 (15%) / 32 (12%)

56 (21%) / 51 (18%)

95 (18%) / 83 (15%)

One trial was conducted primarily in the United States and South Africa (study 9801), and the second was conducted at non-US sites only (study 9901). The two trials were similar in design but differed in patient characteristics, including history of diabetes and peripheral vascular disease. There were a total of 534 adult patients treated with Daptomycin for Injection and 558 treated with comparator in the two trials. The majority (89.7%) of patients received IV medication exclusively.

The efficacy endpoints in both trials were the clinical success rates in the intent-to-treat (ITT) population and in the clinically evaluable (CE) population. In study 9801, clinical success rates in the ITT population were 62.5% (165/264) in patients treated with Daptomycin for Injection and 60.9% (162/266) in patients treated with comparator drugs. Clinical success rates in the CE population were 76.0% (158/208) in patients treated with Daptomycin for Injection and 76.7% (158/206) in patients treated with comparator drugs. In study 9901, clinical success rates in the ITT population were 80.4% (217/270) in patients treated with Daptomycin for Injection and 80.5% (235/292) in patients treated with comparator drugs. Clinical success rates in the CE population were 89.9% (214/238) in patients treated with Daptomycin for Injection and 90.4% (226/250) in patients treated with comparator drugs.

The success rates by pathogen for microbiologically evaluable patients are presented in Table 16.

Table 16: Clinical Success Rates by Infecting Pathogen in the cSSSI Trials in Adult Patients (Population: Microbiologically Evaluable)
*
Comparator: vancomycin (1 g IV q12h) or an anti-staphylococcal semi-synthetic penicillin (i.e., nafcillin, oxacillin, cloxacillin, or flucloxacillin; 4 to 12 g/day IV in divided doses).
As determined by the central laboratory.

Pathogen

Success Rate n/N (%)

Daptomycin for Injection

Comparator *

Methicillin-susceptible Staphylococcus aureus (MSSA)

170/198 (86%)

180/207 (87%)

Methicillin-resistant Staphylococcus aureus (MRSA)

21/28 (75%)

25/36 (69%)

Streptococcus pyogenes

79/84 (94%)

80/88 (91%)

Streptococcus agalactiae

23/27 (85%)

22/29 (76%)

Streptococcus dysgalactiae subsp. equisimilis

8/8 (100%)

9/11 (82%)

Enterococcus faecalis (vancomycin-susceptible only)

27/37 (73%)

40/53 (76%)

Pediatric use information is approved for Merck & Co., Inc.’s Cubicin (daptomycin for injection). However, due to Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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