Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Skin and Subcutaneous Tissue Bacterial Infections Clinical Trial

Official title:
A Phase 3, Multicenter, Randomized, Double-blind, Active Controlled Study to Evaluate the Efficacy + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effects of Delafloxacin versus Vancomycin plus Aztreonam in the treatment of patients with acute bacterial skin and soft tissue infections.

Clinical Trial Description

The purpose of this study is to determine if delafloxacin, an investigational drug, is safe and effective in the treatment of skin and nearby tissue infections compared with a combination of other antibiotics, vancomycin and aztreonam. ;

Study Design

Related Conditions & MeSH terms

Bacterial Infections
Communicable Diseases
Infection
Skin and Subcutaneous Tissue Bacterial Infections
Skin Structures and Soft Tissue Infections
Soft Tissue Infections

Clinical Trial Details

NCT number	NCT01984684
Study type	Interventional
Source	Melinta Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	May 2014
Completion date	January 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01421511` - TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections	Phase 3
Active, not recruiting	`NCT02572791` - Staph Household Intervention for Eradication (SHINE)	Phase 4
Completed	`NCT02796716` - Study of Accuracy of New Diagnostic Technology to Guide Rapid Antibiotic Treatment for Serious Infections	N/A
Completed	`NCT01283581` - A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections	Phase 2
Completed	`NCT01519492` - A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections Due to Staphylococci	Phase 2
Completed	`NCT02060513` - Study of Accuracy of New Diagnostic Technology to Determine Guide Rapid Antibiotic Treatment for Serious Infections	N/A
Completed	`NCT01170221` - TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.	Phase 3
Completed	`NCT01811732` - Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections	Phase 3
Completed	`NCT03964493` - TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection	Phase 2