Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
This study has been completed.
Sponsor:
Novexel Inc
Information provided by:
Novexel Inc
ClinicalTrials.gov Identifier:
NCT00949130
First received: July 29, 2009
Last updated: March 17, 2010
Last verified: March 2010
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Purpose
The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs. established treatment of acute bacterial infection in adults.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Bacterial Skin and Skin Structure Infections |
Drug: NXL103 Drug: Linezolid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Novexel Inc:
Primary Outcome Measures:
- Clinical response at the early follow-up visit (Test of cure) [ Time Frame: 7 days post therapy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical outcome at the late follow-up visit [ Time Frame: 21 days post therapy ] [ Designated as safety issue: No ]
- Clinical outcome at the end of treatment [ Time Frame: 10-14 days therapy ] [ Designated as safety issue: No ]
- Microbiological outcome at the early follow-up visit (Test of cure) [ Time Frame: 7 days post-therapy ] [ Designated as safety issue: No ]
- Safety Profiles (safety and tolerability) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- Population pharmacokinetic profile of the experimental study drug [ Time Frame: Day 1-5 while on study drug ] [ Designated as safety issue: No ]
| Enrollment: | 180 |
| Study Start Date: | November 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NXL103
BID for 7-14 days orally
|
Drug: NXL103
BID for 7-14 days
|
|
Active Comparator: Linezolid
BID for 7-14 days orally
|
Drug: Linezolid
BID for 7-14 days
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949130
Locations
| United States, California | |
| Sharp Chula Vista Research Office | |
| Chula Vista, California, United States, 91911 | |
| Fountain Valley Regional Hospital and Medical Center | |
| Fountain Valley, California, United States, 92708 | |
| Sharp Grossmont Research Office | |
| LaMesa, California, United States, 91942 | |
| Tri-City Oceanside Office | |
| Oceanside, California, United States, 92056 | |
| United States, Georgia | |
| Southeast Regional Research Group | |
| Columbus, Georgia, United States, 31904 | |
| Southeast Regional Research Group | |
| Savannah, Georgia, United States, 31406 | |
| United States, Idaho | |
| Idaho Falls Infectious Diseases | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Minnesota | |
| Hennepin County Medical Center | |
| Minneapolis, Minnesota, United States, 55415 | |
| Infectious Diseaes MPLS-LTD | |
| Minneapolis, Minnesota, United States, 55422 | |
| United States, Montana | |
| Mercury Street Medical Group | |
| Butte, Montana, United States, 59701 | |
| United States, Pennsylvania | |
| RPS Infectious Diseases | |
| West Reading, Pennsylvania, United States, 19611 | |
| Guatemala | |
| Roosevelt Hospital | |
| Guatemala, Guatemala, 1011 | |
| Military Health Center | |
| Guatemala, Guatemala | |
| UNICAR | |
| Guatemala, Guatemala, 1011 | |
| Private Hospital | |
| Quetzaltenango, Guatemala | |
Sponsors and Collaborators
Novexel Inc
Investigators
| Study Director: | Michael Kuligowski, MD | Novexel Inc |
More Information
No publications provided
| Responsible Party: | Dr. Michael Kuligowski, Director of Clinical Research, Novexel Inc |
| ClinicalTrials.gov Identifier: | NCT00949130 History of Changes |
| Other Study ID Numbers: | NXL103/2002 |
| Study First Received: | July 29, 2009 |
| Last Updated: | March 17, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Linezolid Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013