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Completed

NCT Number: NCT00299520

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

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).

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Key information

Conditions

Complicated Skin and Skin Structure Infection Cellulitis Connective Tissue Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

e-Study Site, National City, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous iclaprim or intravenous linezolid

Drug

Primary outcomes

  1. 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

  1. Microbiological eradication rate at 7-14 days after end of therapy.

  2. Safety evaluations conducted during the study

Sponsors and collaborators

Lead sponsor

Arpida AG

Industry

Registry information

Official study 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)

Important dates

Study start
2005
Study completion
2006
First posted
Mar 7, 2006
Registry last updated
Apr 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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