Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Information source: Novexel Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Bacterial Skin and Skin Structure Infections
Intervention: NXL103 (Drug); Linezolid (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novexel Inc Official(s) and/or principal investigator(s): Michael Kuligowski, MD, Study Director, Affiliation: Novexel Inc
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Clinical response at the early follow-up visit (Test of cure)
Secondary outcome: Clinical outcome at the late follow-up visitClinical outcome at the end of treatment Microbiological outcome at the early follow-up visit (Test of cure) Safety Profiles (safety and tolerability) Population pharmacokinetic profile of the experimental study drug
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Military Health Center, Guatemala, Guatemala
Roosevelt Hospital, Guatemala 1011, Guatemala
UNICAR, Guatemala 1011, Guatemala
Private Hospital, Quetzaltenango, Guatemala
Sharp Chula Vista Research Office, Chula Vista, California 91911, United States
Fountain Valley Regional Hospital and Medical Center, Fountain Valley, California 92708, United States
Sharp Grossmont Research Office, LaMesa, California 91942, United States
Tri-City Oceanside Office, Oceanside, California 92056, United States
Southeast Regional Research Group, Columbus, Georgia 31904, United States
Southeast Regional Research Group, Savannah, Georgia 31406, United States
Idaho Falls Infectious Diseases, Idaho Falls, Idaho 83404, United States
Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States
Infectious Diseaes MPLS-LTD, Minneapolis, Minnesota 55422, United States
Mercury Street Medical Group, Butte, Montana 59701, United States
RPS Infectious Diseases, West Reading, Pennsylvania 19611, United States
Additional Information
Starting date: November 2009
Last updated: March 17, 2010
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