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NCT Number: NCT00949130

Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs. established treatment of acute bacterial infection in adults.

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Key information

Conditions

Acute Bacterial Skin and Skin Structure Infections

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Military Health Center, Guatemala City, Guatemala

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with acute bacterial skin and skin structure infection (ABSSSI) with at least 3 signs or symptoms

Exclusion criteria

  • Uncomplicated acute bacterial skin and skin structure infections
  • ABSSSI suspected or proven to be due to Gram negative and/or anaerobic pathogens
  • Pregnant or lactating women
  • Inadequately controlled diabetes mellitus
  • Inadequately controlled arterial hypertension
  • Moderate-to-severe renal impairment
  • Moderate-to-severe liver disease
  • Conditions associated with immunodeficiency
  • Known hypersensitivity or any contraindication for the use of any of the 2 study drugs

Treatment and study plan

NXL103

Drug

BID for 7-14 days

Linezolid

Drug

BID for 7-14 days

Primary outcomes

  1. Clinical response at the early follow-up visit (Test of cure)

    Time frame: 7 days post therapy

Secondary outcomes

  1. Clinical outcome at the late follow-up visit

    Time frame: 21 days post therapy

  2. Clinical outcome at the end of treatment

    Time frame: 10-14 days therapy

  3. Microbiological outcome at the early follow-up visit (Test of cure)

    Time frame: 7 days post-therapy

  4. Safety Profiles (safety and tolerability)

    Time frame: throughout the study

  5. Population pharmacokinetic profile of the experimental study drug

    Time frame: Day 1-5 while on study drug

Sponsors and collaborators

Lead sponsor

Novexel Inc

Industry

Registry information

Official study title

A Multicenter,Investigator-blinded,Randomized, Comparative Study to Evaluate the Efficacy and Safety of Oral NXL103 Versus Oral Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 30, 2009
Registry last updated
Mar 18, 2010

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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