A Phase 2 interventional study of Telavancin and Vancomycin or antistaphylococcal penicillin in Infections, Gram-Positive Bacterial, Abscess and Burns, 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
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 169 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Cumberland Pharmaceuticals is the lead sponsor of 47 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.
Counted across the registry records on this site, refreshed daily.
Patients must have a diagnosis of one of the following complicated skin and skin structure infections with either a suspected or confirmed Gram positive organism as the major cause of the infection:
Exclusion Criteria:
Drug: Telavancin
cSSSI - complicated skin and skin structure infections
Drug: Vancomycin or antistaphylococcal penicillin
Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days
Also known as: VIBATIV, TD-6424
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.
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 the Test-of-Cure (TOC) visit. * Indeterminate: Inability to determine outcome.
Time frame: 7-14 days following end of antibiotic treatment
Enrollment Period: 05Jun03 to 20Jan04
| Milestone | Telavancin | Standard of Care for cSSSI |
|---|---|---|
| Started | 84 | 85 |
| Completed | 79 | 74 |
| Not completed | 5 | 11 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Lost to follow-up | 1 | 4 |
| Withdrew: Other | 1 | 1 |
| Withdrew: Never received study treatment | 0 | 2 |
* 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 the Test-of-Cure (TOC) visit. * Indeterminate: Inability to determine outcome.
| participants | Telavancin | Standard of Care for cSSSI |
|---|---|---|
| Cured | 66 | 66 |
| Failure | 6 | 3 |
| Indeterminate | 0 | 0 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Telavancin | — | 3/84 (3.6%) | 46/84 (54.8%) |
| Standard of Care for cSSSI | — | 9/83 (10.8%) | 50/83 (60.2%) |
| Event | Telavancin | Standard of Care for cSSSI |
|---|---|---|
| CellulitisInfections and infestations | 0/84 | 3/83 |
| Subcutaneous AbscessInfections and infestations | 0/84 | 1/83 |
| Wound AbscessInfections and infestations | 0/84 | 1/83 |
| Wound dehiscenceInjury, poisoning and procedural complications | 0/84 | 1/83 |
| Inguinal massMusculoskeletal and connective tissue disorders | 0/84 | 1/83 |
| Vaginal HaemorrhageReproductive system and breast disorders | 0/84 | 1/83 |
| Angioneurotic OedemaSkin and subcutaneous tissue disorders | 0/84 | 1/83 |
| Necrotizing FasciitisInfections and infestations | 1/84 | 0/83 |
| Wound InfectionInfections and infestations | 1/84 | 0/83 |
| GangreneVascular disorders | 1/84 | 0/83 |
| Event | Telavancin | Standard of Care for cSSSI |
|---|---|---|
| NauseaGastrointestinal disorders | 13/84 | 11/83 |
| HeadacheNervous system disorders | 9/84 | 8/83 |
| VomitingGastrointestinal disorders | 8/84 | 3/83 |
| Aspartate Aminotransferase increasedInvestigations | 1/84 | 6/83 |
| AnxietyPsychiatric disorders | 6/84 | 2/83 |
| ConstipationGastrointestinal disorders | 3/84 | 5/83 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/84 | 1/83 |
| Urinary Tract InfectionInfections and infestations | 4/84 | 4/83 |
| Alanine Aminotransferase increasedInvestigations | 0/84 | 4/83 |
| InsomniaPsychiatric disorders | 0/84 | 4/83 |
| Age, Categorical(Participants) | Telavancin | Standard of Care for cSSSI | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 80 | 78 | 158 |
| >=65 years | 4 | 5 | 9 |
| Age, Continuous(years) | Telavancin | Standard of Care for cSSSI | Total |
|---|---|---|---|
| Mean | 44.6 ± 13.9 | 44.3 ± 13.5 | 44.4 ± 13.7 |
| Sex: Female, Male(Participants) | Telavancin | Standard of Care for cSSSI | Total |
|---|---|---|---|
| Female | 30 | 37 | 67 |
| Male | 54 | 46 | 100 |
| Ethnicity (NIH/OMB)(Participants) | Telavancin | Standard of Care for cSSSI | Total |
|---|---|---|---|
| Hispanic or Latino | 15 | 10 | 25 |
| Not Hispanic or Latino | 68 | 72 | 140 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Telavancin | Standard of Care for cSSSI | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 4 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 6 | 5 | 11 |
| Black or African American | 21 | 20 | 41 |
| White | 38 | 41 | 79 |
| More than one race | 13 | 14 | 27 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Region of Enrollment(participants) | Telavancin | Standard of Care for cSSSI | Total |
|---|---|---|---|
| United States | 59 | 58 | 117 |
| South Africa | 25 | 25 | 50 |
| Diabetes Status(participants) | Telavancin | Standard of Care for cSSSI | Total |
|---|---|---|---|
| Diabetic | 25 | 19 | 44 |
| Non-Diabetic | 59 | 64 | 123 |
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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Cumberland Pharmaceuticals