Infections, Gram-positive Bacterial
Conditions
Keywords
Abscess, Burns, Cellulitis, Ulcer, Wound infections
Brief summary
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.
Interventions
DRUGTelavancin
Telavancin 7.5 mg/kg/day, amended to 10 mg/kg/day, IV (intravenously) for up to 14 days
Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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 soft tissue infections and either a suspected or confirmed Gram positive organism * 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 Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population | 7 to 14 days following completion of antibiotic treatment | * Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary. * Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit * Indeterminate: Inability to determine outcome. |
Countries
United States
Participant flow
Recruitment details
Enrollment Period: 20Feb2004 to 09SEP2004
Participants by arm
| Arm | Count |
|---|---|
| Telavancin Telavancin 10 mg/kg every 24 hours intravenously | 100 |
| Standard of Care for cSSSI Standard therapy \[nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously\] | 95 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 6 | 3 |
| Overall Study | Never received study treatment | 3 | 3 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Telavancin | Standard of Care for cSSSI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 4 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 92 Participants | 91 Participants | 183 Participants |
| Age, Continuous | 44.7 years STANDARD_DEVIATION 13.7 | 42.3 years STANDARD_DEVIATION 10.8 | 43.6 years STANDARD_DEVIATION 12.4 |
| Diabetes Status Diabetic | 18 participants | 14 participants | 32 participants |
| Diabetes Status Not Diabetic | 82 participants | 81 participants | 163 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 17 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 86 Participants | 78 Participants | 164 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 30 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 24 Participants | 19 Participants | 43 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 41 Participants | 43 Participants | 84 Participants |
| Region of Enrollment South Africa | 42 participants | 41 participants | 83 participants |
| Region of Enrollment United States | 58 participants | 54 participants | 112 participants |
| Sex: Female, Male Female | 45 Participants | 33 Participants | 78 Participants |
| Sex: Female, Male Male | 55 Participants | 62 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 56 / 100 | 54 / 95 |
| serious Total, serious adverse events | 7 / 100 | 3 / 95 |
Outcome results
Primary
Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
* Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary. * Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit * Indeterminate: Inability to determine outcome.
Time frame: 7 to 14 days following completion of antibiotic treatment
Population: The CE population was a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of cure or failure. The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telavancin | Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population | Cured | 74 participants |
| Telavancin | Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population | Failure | 3 participants |
| Standard of Care for cSSSI | Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population | Cured | 72 participants |
| Standard of Care for cSSSI | Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population | Failure | 5 participants |
Comparison: 95% Confidence Interval: -0.0527 to 0.1102 No estimated value Parameter that was estimated: Risk Differencep-value: 0.53182-sided 95% confidence interval calculat