Study of Intravenous (I.V.) Iclaprim Versus Linezolid in... | NCT00303550

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

NCT00303550

Sponsor

Arpida AG

Status

Completed

Last Update Posted

Mar 27, 2007Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Skin Diseases, Bacterial

Interventions

Intravenous iclaprim
Intravenous linezolid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ASSIST-2

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 15, 2006

First Submission Date that Met QC Criteria

Mar 15, 2006

First Posted Date

Mar 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2007

Last Update Posted Date

Mar 27, 2007Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Edward Hospital & Health Services		Naperville	Illinois	60540	United States
Wyoming Medical Center

Label	URL
ARPIDA AG corporate website	View source

Condition Browse Module

MeSH Terms

ID	Term
D017192	Skin Diseases, Bacterial
D002481	Cellulitis

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D012874	Skin Diseases, Infectious

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Intravenous iclaprim	Drug
Intravenous linezolid	Drug