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A Study for Patients With Complicated Skin and Skin Structure Infections

NCT00514527 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2008-08-14

No results posted yet for this study

Summary

Two Phase III trials to demonstrate the efficacy and safety of oritavancin in the treatment of complicated skin and skin structure infections (cSSSI) have been completed.

The pharmacokinetic profile of oritavancin in humans suggests that oritavancin has the potential to be used safely and effectively when given either as a single dose or as an infrequent dose for cSSSI. Data from animals support this theory.

SIMPLIFI has been designed to evaluate the efficacy and safety of either a single dose of oritavancin or an infrequent dose of oritavancin (First dose on Day one with an option for a second dose on Day five) compared to the previously studied dosing regimen of 200mg oritavancin given once daily for 3 to 7 days.

Conditions

  • Staphylococcal Skin Infections
  • Wounds and Injuries
  • Abscess
  • Cellulitis
  • Streptococcal Infections

Interventions

DRUG

oritavancin

Oritavancin as a single, infrequent or daily dose.

Sponsors & Collaborators

  • Targanta Therapeutics Corporation

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-04-30
Completion
2008-05-31

Countries

  • United States
  • Australia
  • India
  • Italy
  • Romania
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00514527 on ClinicalTrials.gov