Gram-Positive Bacterial Infections
Conditions
Brief summary
The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.
Interventions
DRUGTelavancin
Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days
DRUGVancomycin, nafcillin, oxacillin, or cloxacillin
Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) 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
\- Documented S. aureus bacteremia
Exclusion criteria
\- Patients who had received or would have received more than 72 hours of potentially effective systemic antistaphylococcal therapy within 7 days prior to randomization. The following agents were considered potentially effective antistaphylococcal therapy: antistaphylococcal penicillins (including nafcillin, oxacillin, or cloxacillin), cephalosporins, fluoroquinolones, glycopeptides (including vancomycin and teicoplanin) and linezolid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation | 12 weeks after start of treatment | Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size. |
Countries
United States
Participant flow
Recruitment details
Enrollment period: 14 Aug 2003 to 02 Aug 2006
Participants by arm
| Arm | Count |
|---|---|
| Telavancin Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy. | 29 |
| Standard Therapy Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy. | 29 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Death | 2 | 2 |
| Overall Study | Failed continuation criteria | 4 | 2 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Never received study treatment | 1 | 1 |
| Overall Study | Other | 4 | 4 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Telavancin | Standard Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 18 Participants | 36 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 19 | 60 years STANDARD_DEVIATION 17.9 | 60 years STANDARD_DEVIATION 17.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 7 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 22 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 21 Participants | 38 Participants |
| Region of Enrollment Argentina | 3 participants | 2 participants | 5 participants |
| Region of Enrollment Hong Kong | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Singapore | 1 participants | 3 participants | 4 participants |
| Region of Enrollment Spain | 2 participants | 3 participants | 5 participants |
| Region of Enrollment United States | 22 participants | 21 participants | 43 participants |
| Sex: Female, Male Female | 11 Participants | 14 Participants | 25 Participants |
| Sex: Female, Male Male | 18 Participants | 15 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 29 | 21 / 29 |
| serious Total, serious adverse events | 11 / 29 | 6 / 29 |
Outcome results
Primary
Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation
Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.
Time frame: 12 weeks after start of treatment
Population: The primary efficacy analysis was of the CE Population, defined as those patients meeting meeting inclusion/exclusion criteria, meeting continuation criteria, receiving assigned study drug for at least 14 days and available for assessment of response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telavancin | Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation | Cured | 7 participants |
| Telavancin | Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation | Failure | 1 participants |
| Standard Therapy | Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation | Cured | 8 participants |
| Standard Therapy | Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation | Failure | 1 participants |
95% CI: [-35.5, 31.9]the difference in the 2 eradication rate