Study of Intravenous (I.V.) Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections [cSSSI] (ASSIST-2)

Phase 3, Randomized, Investigator-Blind, Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections (ASSIST-2)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00303550

Enrollment

Unknown

Registered

2006-03-17

Start date

2006-03-31

Completion date

Unknown

Last updated

2007-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Diseases, Bacterial

Keywords

skin infection, complicated skin infection, skin structure infection, Complicated Skin and Skin Structure Infection

Brief summary

The study is now completed

Detailed description

Primary Objective: The primary objective of this study is to compare the clinical cure rates of iclaprim and linezolid at the test of cure (TOC) visit (7 to 14 days after the end of treatment). Secondary Objectives: The secondary objectives of this study are to compare iclaprim with linezolid regarding: * Clinical efficacy at the end of study medication treatment; * Time to resolution of systemic and local signs and symptoms of complicated skin and skin structure infection (cSSSI); * Clinical outcome in the microbiologically evaluable (ME) population; * Bacteriologic outcome in the ME population; * Bacteriologic eradication rates of Baseline (BL) pathogens; * Clinical outcome in the modified intent-to-treat (MITT) population; * Bacteriologic outcome in the MITT population; * Baseline in vitro susceptibility of isolated pathogens in the ME population; and * Safety and tolerability of iclaprim treatment.

Interventions

DRUGIntravenous iclaprim

DRUGIntravenous linezolid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of an infection consistent with complicated skin and skin structure infection due to a gram positive pathogen.

Exclusion criteria

* Known or suspected hypersensitivity to any study medication or other related anti-infective medication * Any known or suspected condition or concurrent treatment contraindicated by the prescribing information * Previous enrollment in this study * Treatment with any investigational drug within 30 days before enrollment

Design outcomes

Primary

Measure	Time frame
Clinical cure rate (the ratio of number of clinically cured patients to the total number of patients in the population) at 7 to 14 days after the end of therapy	—

Secondary

Measure	Time frame
Microbiological eradication rate at 7-14 days after end of therapy	—
Safety evaluations conducted during the study	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026