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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00061633
Other study ID # I6424-202a
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2003
Est. completion date January 2004

Study information

Verified date January 2019
Source Cumberland Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 169
Est. completion date January 2004
Est. primary completion date January 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

- infected burn (see exclusion criteria for important qualifications)

- deep/extensive cellulitis

- infected ulcer (see exclusion criteria for important qualifications)

- wound infections

- Patients must be expected to require at least 4 days of intravenous antibiotic treatment

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Telavancin
Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days
Vancomycin or antistaphylococcal penicillin
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.

Locations

Country Name City State
United States eStudy Site, 3450 Bonita Road, Ste 201 Chula Vista California

Sponsors (1)

Lead Sponsor Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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 the Test-of-Cure (TOC) visit.
Indeterminate: Inability to determine outcome.
7-14 days following end of antibiotic treatment
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