MedTrace Logo

A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections

NCT01283581 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2019-10-16

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials

Conditions

  • Skin and Subcutaneous Tissue Bacterial Infections

Interventions

DRUG

Delafloxacin

300mg IV every 12 hours for 5-14 days

DRUG

Linezolid

600mg IV every 12 hours for 5-14 days

DRUG

Vancomycin

15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days

Sponsors & Collaborators

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Hopkins, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01283581 on ClinicalTrials.gov