NCT00061633

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2003

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
6 years until next milestone

Results Posted

Study results publicly available

January 11, 2010

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

May 30, 2003

Results QC Date

December 2, 2009

Last Update Submit

January 14, 2019

Conditions

Infections, Gram-Positive BacterialAbscessBurnsCellulitisUlcerWound Infections

Outcome Measures

Primary Outcomes (1)

  • 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.

    7-14 days following end of antibiotic treatment

Study Arms (2)

Telavancin

EXPERIMENTAL
Drug: Telavancin

Standard of care for cSSSI

ACTIVE COMPARATOR

cSSSI - complicated skin and skin structure infections

Drug: Vancomycin or antistaphylococcal penicillin

Interventions

TelavancinDRUG

Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days

Also known as: VIBATIV, TD-6424
Telavancin
Vancomycin or antistaphylococcal penicillinDRUG

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.

Standard of care for cSSSI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • major abscess requiring surgical incision and drainage

You may not qualify if:

  • deep/extensive cellulitis
  • wound infections
  • Patients must be expected to require at least 4 days of intravenous antibiotic treatment
  • Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for \> 24 hours within 7 days prior to the first dose of study medication unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days).
  • Burns involving \> 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

eStudy Site, 3450 Bonita Road, Ste 201

Chula Vista, California, 91910, United States

Location

MeSH Terms

Conditions

Gram-Positive Bacterial InfectionsAbscessBurnsCellulitisUlcerWound Infection

Interventions

telavancinVancomycin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSuppurationInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesSkin Diseases, InfectiousConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs
Organization
Theravance, Inc
sbarriere@theravance.com
650-808-6132

Study Officials

  • G. Ralph Corey, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2003

First Posted

June 2, 2003

Study Start

June 1, 2003

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

January 16, 2019

Results First Posted

January 11, 2010

Record last verified: 2019-01

Locations

US(1)