Staphylococcal Skin Infection
Conditions
Keywords
cSSSI (complicated Skin and Skin Structure Infections), Staph (Staphylococcus), MRSA (Methicillin-resistant Staphylococcus Aureus)
Brief summary
Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
Interventions
DRUGTelavancin
Telavancin 10 mg/kg/day, IV for up to 14 days.
DRUGVancomycin
Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection: * major abscess requiring surgical incision and drainage; * infected burn (see
Exclusion criteria
for important qualifications); * deep/extensive cellulitis; * infected ulcer (see
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response | 7 to 14 days after the last antibiotic dose | The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome. |
Countries
United States
Participant flow
Recruitment details
Enrollment Period: 18 February 2005 to 31 May 2006
Participants by arm
| Arm | Count |
|---|---|
| Telavancin Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days. | 458 |
| Vancomycin Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days. | 481 |
| Total | 939 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 5 |
| Overall Study | Death | 3 | 3 |
| Overall Study | Lost to Follow-up | 20 | 28 |
| Overall Study | Other | 5 | 4 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 9 |
Baseline characteristics
| Characteristic | Vancomycin | Total | Telavancin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 102 Participants | 183 Participants | 81 Participants |
| Age, Categorical Between 18 and 65 years | 379 Participants | 756 Participants | 377 Participants |
| Age, Continuous | 49.9 years STANDARD_DEVIATION 17 | 49.5 years STANDARD_DEVIATION 16.6 | 49.2 years STANDARD_DEVIATION 16.1 |
| Diabetes Status Diabetic | 118 Participants | 231 Participants | 113 Participants |
| Diabetes Status Not diabetic | 363 Participants | 708 Participants | 345 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 84 Participants | 163 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 397 Participants | 776 Participants | 379 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 16 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 44 Participants | 82 Participants | 38 Participants |
| Race (NIH/OMB) Black or African American | 74 Participants | 143 Participants | 69 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 8 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 343 Participants | 679 Participants | 336 Participants |
| Region of Enrollment Argentina | 33 participants | 68 participants | 35 participants |
| Region of Enrollment Canada | 29 participants | 64 participants | 35 participants |
| Region of Enrollment Chile | 2 participants | 3 participants | 1 participants |
| Region of Enrollment France | 2 participants | 2 participants | 0 participants |
| Region of Enrollment Germany | 4 participants | 4 participants | 0 participants |
| Region of Enrollment Italy | 1 participants | 3 participants | 2 participants |
| Region of Enrollment Korea, Republic of | 16 participants | 30 participants | 14 participants |
| Region of Enrollment Lithuania | 6 participants | 18 participants | 12 participants |
| Region of Enrollment Peru | 1 participants | 5 participants | 4 participants |
| Region of Enrollment Poland | 43 participants | 81 participants | 38 participants |
| Region of Enrollment South Africa | 6 participants | 12 participants | 6 participants |
| Region of Enrollment Spain | 3 participants | 5 participants | 2 participants |
| Region of Enrollment Taiwan | 25 participants | 45 participants | 20 participants |
| Region of Enrollment United Kingdom | 0 participants | 2 participants | 2 participants |
| Region of Enrollment United States | 310 participants | 597 participants | 287 participants |
| Sex: Female, Male Female | 187 Participants | 387 Participants | 200 Participants |
| Sex: Female, Male Male | 294 Participants | 552 Participants | 258 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 377 / 503 | 341 / 509 |
| serious Total, serious adverse events | 38 / 503 | 15 / 509 |
Outcome results
Primary
Clinical Response
The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.
Time frame: 7 to 14 days after the last antibiotic dose
Population: Data for the all-treated population (AT) are presented. The AT and clinically evaluable (CE) populations were considered co-primary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telavancin | Clinical Response | Not cured | 59 patients |
| Telavancin | Clinical Response | Missing | 24 patients |
| Telavancin | Clinical Response | Indeterminate | 17 patients |
| Telavancin | Clinical Response | Cure | 358 patients |
| Vancomycin | Clinical Response | Indeterminate | 20 patients |
| Vancomycin | Clinical Response | Not cured | 57 patients |
| Vancomycin | Clinical Response | Cure | 364 patients |
| Vancomycin | Clinical Response | Missing | 40 patients |
95% CI: [-2.9, 7.9]2-sided 95% confidence interval