A Phase 2 interventional study of Telavancin and Vancomycin, nafcillin, oxacillin, or cloxacillin in Gram-Positive Bacterial Infections, sponsored by Cumberland Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by Cumberland Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
49 studies on the registry are indexed under Gram-Positive Bacterial Infections; 5 are open to participants now.
This study's enrollment of 60 is below the median of 86 across 35 interventional studies indexed under Gram-Positive Bacterial Infections.
Browse Gram-Positive Bacterial Infections studies →Cumberland Pharmaceuticals is the lead sponsor of 49 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
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- 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
Drug: Telavancin
Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously
Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin
Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days
Also known as: TD-6424, VIBATIV
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.
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
Enrollment period: 14 Aug 2003 to 02 Aug 2006
| Milestone | Telavancin | Standard Therapy |
|---|---|---|
| Started | 30 | 30 |
| Completed | 14 | 17 |
| Not completed | 16 | 13 |
| Withdrew: Death | 2 | 2 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Failed continuation criteria | 4 | 2 |
| Withdrew: Other | 4 | 4 |
| Withdrew: Never received study treatment | 1 | 1 |
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.
| participants | Telavancin | Standard Therapy |
|---|---|---|
| Cured | 7 | 8 |
| Failure | 1 | 1 |
Collected over From receipt of first dose through last follow-up assessment (up to Day 98).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telavancin | — | 11/29 (37.9%) | 26/29 (89.7%) |
| Standard Therapy | — | 6/29 (20.7%) | 21/29 (72.4%) |
| Event | Telavancin | Standard Therapy |
|---|---|---|
| Abdominal PainGastrointestinal disorders | 0/29 | 1/29 |
| NauseaGastrointestinal disorders | 0/29 | 1/29 |
| VomitingGastrointestinal disorders | 0/29 | 1/29 |
| Adverse Drug ReactionGeneral disorders | 1/29 | 0/29 |
| DeathGeneral disorders | 1/29 | 0/29 |
| Multi-organ FailureGeneral disorders | 1/29 | 1/29 |
| Neuroleptic Malignant SyndromeGeneral disorders | 0/29 | 1/29 |
| PyrexiaGeneral disorders | 1/29 | 0/29 |
| HypersensitivityImmune system disorders | 0/29 | 1/29 |
| EndocarditisInfections and infestations | 0/29 | 1/29 |
| Event | Telavancin | Standard Therapy |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 3/29 | 2/29 |
| PyrexiaGeneral disorders | 3/29 | 2/29 |
| HypokalemiaMetabolism and nutrition disorders | 3/29 | 1/29 |
| DysgeusiaNervous system disorders | 3/29 | 0/29 |
| HeadacheNervous system disorders | 3/29 | 3/29 |
| Deep Vein ThrombosisVascular disorders | 3/29 | 1/29 |
| EosinophiliaBlood and lymphatic system disorders | 0/29 | 2/29 |
| DiarrhoeaGastrointestinal disorders | 0/29 | 2/29 |
| NauseaGastrointestinal disorders | 1/29 | 2/29 |
| VomitingGastrointestinal disorders | 1/29 | 2/29 |
| Age, Categorical(Participants) | Telavancin | Standard Therapy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 18 | 36 |
| >=65 years | 11 | 11 | 22 |
| Age, Continuous(years) | Telavancin | Standard Therapy | Total |
|---|---|---|---|
| Mean | 60 ± 19 | 60 ± 17.9 | 60 ± 17.9 |
| Sex: Female, Male(Participants) | Telavancin | Standard Therapy | Total |
|---|---|---|---|
| Female | 11 | 14 | 25 |
| Male | 18 | 15 | 33 |
| Ethnicity (NIH/OMB)(Participants) | Telavancin | Standard Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 7 | 14 |
| Not Hispanic or Latino | 22 | 22 | 44 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Telavancin | Standard Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 2 | 4 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 3 | 12 |
| White | 17 | 21 | 38 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Telavancin | Standard Therapy | Total |
|---|---|---|---|
| Argentina | 3 | 2 | 5 |
| Singapore | 1 | 3 | 4 |
| Spain | 2 | 3 | 5 |
| United States | 22 | 21 | 43 |
| Hong Kong | 1 | 0 | 1 |
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Telavancin
Gram-Positive Bacterial Infections →