Staphylococcal Skin Infection
Conditions
Keywords
staph, MRSA, cSSSI
Brief summary
Study 0017 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 q 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 Methicillin Resistant Staphylococcus aureus (MRSA) 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 | 7-14 days following end of antibiotic treatment | The Clinical Response for each patient was determined by the investigator by assessing a patient's clinical signs and symptoms at the specified evaluation 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: 19 January 2005 to 12 June 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. | 426 |
| Vancomycin Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days. | 429 |
| Total | 855 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Death | 4 | 5 |
| Overall Study | Lost to Follow-up | 26 | 23 |
| Overall Study | Never received study treatment | 3 | 4 |
| Overall Study | Other | 2 | 3 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 8 |
Baseline characteristics
| Characteristic | Telavancin | Total | Vancomycin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 89 Participants | 161 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 337 Participants | 694 Participants | 357 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 17.3 | 48 years STANDARD_DEVIATION 16.7 | 48 years STANDARD_DEVIATION 16.1 |
| Diabetes Status Diabetic | 94 Participants | 192 Participants | 98 Participants |
| Diabetes Status Not diabetic | 332 Participants | 663 Participants | 331 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 114 Participants | 211 Participants | 97 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 312 Participants | 644 Participants | 332 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 59 Participants | 111 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 12 Participants | 9 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 349 Participants | 702 Participants | 353 Participants |
| Region of Enrollment Australia | 18 participants | 33 participants | 15 participants |
| Region of Enrollment Belgium | 2 participants | 2 participants | 0 participants |
| Region of Enrollment Croatia | 49 participants | 100 participants | 51 participants |
| Region of Enrollment Israel | 15 participants | 27 participants | 12 participants |
| Region of Enrollment Malaysia | 5 participants | 9 participants | 4 participants |
| Region of Enrollment Russian Federation | 20 participants | 39 participants | 19 participants |
| Region of Enrollment South Africa | 11 participants | 23 participants | 12 participants |
| Region of Enrollment United States | 306 participants | 622 participants | 316 participants |
| Sex: Female, Male Female | 196 Participants | 377 Participants | 181 Participants |
| Sex: Female, Male Male | 230 Participants | 478 Participants | 248 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 358 / 426 | 335 / 429 |
| serious Total, serious adverse events | 31 / 426 | 27 / 429 |
Outcome results
Primary
Clinical Response
The Clinical Response for each patient was determined by the investigator by assessing a patient's clinical signs and symptoms at the specified evaluation 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: 7-14 days following end of antibiotic treatment
Population: Data for the all-treated (AT) population are presented. the AT and clinically evaluable (CE) populations were considered co-primary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telavancin | Clinical Response | Cure | 323 participants |
| Telavancin | Clinical Response | Not cured | 52 participants |
| Telavancin | Clinical Response | Indeterminate | 23 participants |
| Telavancin | Clinical Response | Missing | 28 participants |
| Vancomycin | Clinical Response | Missing | 34 participants |
| Vancomycin | Clinical Response | Cure | 321 participants |
| Vancomycin | Clinical Response | Indeterminate | 16 participants |
| Vancomycin | Clinical Response | Not cured | 58 participants |
95% CI: [-4.8, 6.8]