NCT00949130

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 18, 2010

Status Verified

March 1, 2010

Enrollment Period

4 months

First QC Date

July 29, 2009

Last Update Submit

March 17, 2010

Conditions

Acute Bacterial Skin and Skin Structure Infections

Outcome Measures

Primary Outcomes (1)

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

    7 days post therapy

Secondary Outcomes (5)

  • Clinical outcome at the late follow-up visit

    21 days post therapy

  • Clinical outcome at the end of treatment

    10-14 days therapy

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

    7 days post-therapy

  • Safety Profiles (safety and tolerability)

    throughout the study

  • Population pharmacokinetic profile of the experimental study drug

    Day 1-5 while on study drug

Study Arms (2)

NXL103

EXPERIMENTAL

BID for 7-14 days orally

Drug: NXL103

Linezolid

ACTIVE COMPARATOR

BID for 7-14 days orally

Drug: Linezolid

Interventions

NXL103DRUG

BID for 7-14 days

NXL103
LinezolidDRUG

BID for 7-14 days

Linezolid

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Sharp Chula Vista Research Office

Chula Vista, California, 91911, United States

Location

Fountain Valley Regional Hospital and Medical Center

Fountain Valley, California, 92708, United States

Location

Sharp Grossmont Research Office

La Mesa, California, 91942, United States

Location

Tri-City Oceanside Office

Oceanside, California, 92056, United States

Location

Southeast Regional Research Group

Columbus, Georgia, 31904, United States

Location

Southeast Regional Research Group

Savannah, Georgia, 31406, United States

Location

Idaho Falls Infectious Diseases

Idaho Falls, Idaho, 83404, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Infectious Diseaes MPLS-LTD

Minneapolis, Minnesota, 55422, United States

Location

Mercury Street Medical Group

Butte, Montana, 59701, United States

Location

RPS Infectious Diseases

West Reading, Pennsylvania, 19611, United States

Location

Roosevelt Hospital

Guatemala City, 1011, Guatemala

Location

UNICAR

Guatemala City, 1011, Guatemala

Location

Military Health Center

Guatemala City, Guatemala

Location

Private Hospital

Quetzaltenango, Guatemala

Location

MeSH Terms

Interventions

flopristin, linopristin drug combinationLinezolid

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael Kuligowski, MD

    Novexel Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 18, 2010

Record last verified: 2010-03

Locations

GU(4)US(11)