Phase 3 Safety and Efficacy Study of I.V. Iclaprim v Linezolid in cSSSI (ASSIST-1)

Complicated Skin and Skin Structure Infection Clinical Trial

Official title:

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-1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299520
• Other study ID #: Protocol No. ICLA-08-CSI1
• Secondary ID: ASSIST-1
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2006
• Last updated: April 2, 2008
• Start date: June 2005
• Est. completion date: July 2006

Study information

• Verified date: April 2008
• Source: Arpida AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, investigator-blind, comparative Phase 3 study. Patients will receive either iclaprim or linezolid for 10 to 14 days. Patients will be evaluated daily for the first four days of study treatment and then every other day, for up to 14 days of the treatment period, at End of Therapy, the Test Of Cure visit (7 to 14 days post treatment), and a Late Follow-up (F/U) visit (7 to 14 days after the TOC visit).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complicated Skin and Skin Structure Infection
• Infection

Intervention

Drug:
• intravenous iclaprim or intravenous linezolid

Locations

Country	Name	City	State
United States	VA Medical Center	Boise	Idaho
United States	Judith Stone. M.D.	Cumberland	Maryland
United States	Infectious Disease of Indiana	Indianapolis	Indiana
United States	e-Study Site	National City	California
United States	ID Clinical Research, Ltd.	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Arpida AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Microbiological eradication rate at 7-14 days after end of therapy.
Secondary	Safety evaluations conducted during the study

External Links

•   ARPIDA AG corporate website