Clinical trial NCT00949130: Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Bacterial Skin and Skin Structure Infections
Lead sponsor: Novexel Inc
Sponsor class: INDUSTRY
First posted: 2009-07-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Clinical response at the early follow-up visit (Test of cure)
timeFrame: 7 days post therapy
Secondary outcomes:
measure: Clinical outcome at the late follow-up visit
timeFrame: 21 days post therapy
measure: Clinical outcome at the end of treatment
timeFrame: 10-14 days therapy
measure: Microbiological outcome at the early follow-up visit (Test of cure)
timeFrame: 7 days post-therapy
measure: Safety Profiles (safety and tolerability)
timeFrame: throughout the study
measure: Population pharmacokinetic profile of the experimental study drug
timeFrame: Day 1-5 while on study drug
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Sharp Chula Vista Research Office
state: California
city: Fountain Valley
country: United States
facility: Fountain Valley Regional Hospital and Medical Center
state: California
city: LaMesa
country: United States
facility: Sharp Grossmont Research Office
state: California
city: Oceanside
country: United States
facility: Tri-City Oceanside Office
state: California
city: Columbus
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Savannah
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Idaho Falls
country: United States
facility: Idaho Falls Infectious Diseases
state: Idaho
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Infectious Diseaes MPLS-LTD
state: Minnesota
city: Butte
country: United States
facility: Mercury Street Medical Group
state: Montana
city: West Reading
country: United States
facility: RPS Infectious Diseases
state: Pennsylvania
city: Guatemala
country: Guatemala
facility: Roosevelt Hospital
city: Guatemala
country: Guatemala
facility: UNICAR
city: Guatemala
country: Guatemala
facility: Military Health Center
city: Quetzaltenango
country: Guatemala
facility: Private Hospital
Study officials:
affiliation: Novexel Inc
name: Michael Kuligowski, MD
role: STUDY_DIRECTOR
References: