Bacterial InfectionsPhase 2ABSSSINCT02269319

MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection

A Phase 2 study testing MRX-I and Linezolid in people with Bacterial Infections, run by MicuRx.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bacterial Infections
What is being tested?: MRX-I and Linezolid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: No sites listed yet
Study dates: Feb 2015to Sep 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Who cannot join

Uncomplicated skin infections
Severe sepsis or septic shock
ABSSSI solely due to gram-negative pathogens
Prior systemic antibiotics within 96 hours of randomization

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of MRX-I Versus Linezolid in Adult Subjects With Acute Bacterial Skin and Skin Structure Infection

The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections

Conditions: Bacterial Infections
Being tested: MRX-I, Linezolid
Keywords: ABSSSI, MRX-I, Acute Bacterial Skin and Skin Structure Infections
Medical subject headings: Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRX-IDrug
Oral MRX-I 800mg given twice a day for 10 days
LinezolidDrug
Also called Zyvox
Oral linezolid 600mg given twice a day for 10 days

Study groups in NCT02269319
Study group	Role	What they receive
MRX-I	Experimental	MRX-I tablets 800 mg given twice a day for 10 days Receives: Drug: MRX-I
Linezolid	Active comparator	Linezolid 600 mg given twice a day for 10 days Receives: Drug: Linezolid

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline
- Did not receive a systemic antibacterial agent with activity against gram-positive organisms
- Did not die of any cause up to EA
Measured: 48-72 hours

Secondary outcomes (1)

Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline
Measured: Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Sep 2015

First posted21 Oct 2014 (estimated)
Study startFeb 2015
Primary completionAug 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bacterial 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02269319
Sponsor's protocol ID: MRX-I-03
Acronym: ABSSSI
Status last verified: Jan 2017
First submitted: 11 Oct 2014
Last updated: 4 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Bacterial Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of MRX-I Versus Linezolid in Adult Subjects With Acute Bacterial Skin and Skin Structure Infection
ClinicalTrials.gov ID: NCT02269319
Acronym / sponsor ID: ABSSSI / MRX-I-03
Conditions: Bacterial Infections
Keywords: ABSSSI, MRX-I, Acute Bacterial Skin and Skin Structure Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: MicuRxIndustry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: Aug 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 21 Oct 2014 (estimated)
Results: Posted 4 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MRX-I	Experimental	Drug: MRX-IMRX-I tablets 800 mg given twice a day for 10 days
Linezolid	Active comparator	Drug: LinezolidLinezolid 600 mg given twice a day for 10 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Key exclusion criteria (4 listed)

Uncomplicated skin infections
Severe sepsis or septic shock
ABSSSI solely due to gram-negative pathogens
Prior systemic antibiotics within 96 hours of randomization

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
MRX-IOral MRX-I 800mg given twice a day for 10 days	Drug	MRX-I
LinezolidAlso: ZyvoxOral linezolid 600mg given twice a day for 10 days	Drug	Linezolid

Primary outcome

Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline
Time frame: 48-72 hours
* Did not receive a systemic antibacterial agent with activity against gram-positive organisms * Did not die of any cause up to EA

1 secondary outcome

Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline
Time frame: Day 10

Results and safety

Results posted to the registry on 4 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MRX-I	80	75
Linezolid	40	36

Primary outcome: Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline

Time frame: 48-72 hours. Count of participants. Unit: Participants

Measure	MRX-I n = 80	Linezolid n = 40
Value	72	35

Population analysed: Intent-to-Treat (ITT)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 39 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRX-I	1 of 80 (1.3%)	47 of 80 (58.8%)	0 of 80
Linezolid	0 of 40 (0%)	12 of 40 (30%)	0 of 40

Limitations and caveats (from the sponsor): Proof of concept study was limited in size and scope. Given the number of male to female subjects, the interpretation of the results were limited. Since the duration of therapy was up to 10 days, assessment of long-term safety risks was limited.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bacterial Infections

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MRX-I and Linezolid in people with Bacterial Infections, run by MicuRx.

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 2 inclusion and 4 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline (time frame: 48-72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02269319.

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 4 Nov 2024.