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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 visit

Clinical 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

Page last updated: August 23, 2015

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