Acute Bacterial Skin and Skin Structure InfectionsPhase 2NCT00949130
Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
A Phase 2 study testing NXL103 and Linezolid in people with Acute Bacterial Skin and Skin Structure Infections, run by Novexel Inc at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Bacterial Skin and Skin Structure Infections
- What is being tested?
- NXL103 and Linezolid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Nov 2009to Mar 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with acute bacterial skin and skin structure infection (ABSSSI) with at least 3 signs or symptoms
Who cannot join
- 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
Show all 9Show fewer
- Moderate-to-severe liver disease
- Conditions associated with immunodeficiency
- Known hypersensitivity or any contraindication for the use of any of the 2 study drugs
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States11 sites
Mercury Street Medical Group
Butte, Montana, 59701
Sharp Chula Vista Research Office
Chula Vista, California, 91911
Southeast Regional Research Group
Columbus, Georgia, 31904
Fountain Valley Regional Hospital and Medical Center
Fountain Valley, California, 92708
Idaho Falls Infectious Diseases
Idaho Falls, Idaho, 83404
Sharp Grossmont Research Office
La Mesa, California, 91942
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Infectious Diseaes MPLS-LTD
Minneapolis, Minnesota, 55422
Tri-City Oceanside Office
Oceanside, California, 92056
Southeast Regional Research Group
Savannah, Georgia, 31406
RPS Infectious Diseases
West Reading, Pennsylvania, 19611
Guatemala4 sites
Roosevelt Hospital
Guatemala City, 1011
UNICAR
Guatemala City, 1011
Military Health Center
Guatemala City
Private Hospital
Quetzaltenango
About this study
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)
The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs. established treatment of acute bacterial infection in adults.
- Being tested
- NXL103, Linezolid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXL103Drug
BID for 7-14 days
LinezolidDrug
BID for 7-14 days
| Study group | Role | What they receive |
|---|---|---|
| NXL103 | Experimental | BID for 7-14 days orally Receives: Drug: NXL103 |
| Linezolid | Active comparator | BID for 7-14 days orally Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response at the early follow-up visit (Test of cure)
Measured: 7 days post therapy
Secondary outcomes (5)
Clinical outcome at the late follow-up visit
Measured: 21 days post therapy
Clinical outcome at the end of treatment
Measured: 10-14 days therapy
Microbiological outcome at the early follow-up visit (Test of cure)
Measured: 7 days post-therapy
Safety Profiles (safety and tolerability)
Measured: throughout the study
Population pharmacokinetic profile of the experimental study drug
Measured: Day 1-5 while on study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bacterial Skin and Skin Structure InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novexel Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Kuligowski, MD, Study director, Novexel Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949130
- Sponsor's protocol ID
- NXL103/2002
- Status last verified
- Mar 2010
- First submitted
- 29 Jul 2009
- Last updated
- 18 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00949130
- Acronym / sponsor ID
- NXL103/2002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Novexel IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs. established treatment of acute bacterial infection in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NXL103 | Experimental | Drug: NXL103BID for 7-14 days orally |
| Linezolid | Active comparator | Drug: LinezolidBID for 7-14 days orally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with acute bacterial skin and skin structure infection (ABSSSI) with at least 3 signs or symptoms
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NXL103BID for 7-14 days | Drug | NXL103 |
| LinezolidBID for 7-14 days | Drug | Linezolid |
Primary outcome
Clinical response at the early follow-up visit (Test of cure)
Time frame: 7 days post therapy
5 secondary outcomes
Clinical outcome at the late follow-up visit
Time frame: 21 days post therapy
Clinical outcome at the end of treatment
Time frame: 10-14 days therapy
Microbiological outcome at the early follow-up visit (Test of cure)
Time frame: 7 days post-therapy
Safety Profiles (safety and tolerability)
Time frame: throughout the study
Population pharmacokinetic profile of the experimental study drug
Time frame: Day 1-5 while on study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kuligowski, MD study director
Novexel Inc
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NXL103 and Linezolid in people with Acute Bacterial Skin and Skin Structure Infections, run by Novexel Inc at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response at the early follow-up visit (Test of cure) (time frame: 7 days post therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2010.