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Acute Bacterial Skin and Skin Structure InfectionsPhase 3NCT02570490

Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

A Phase 3 study testing sodium fusidate and linezolid in people with Acute Bacterial Skin and Skin Structure Infections, run by Arrevus Inc. at 62 sites in 2 countries.

Completed

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

Official record
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Trial summary

Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
sodium fusidate and linezolid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
716 participants
Where
62 sitesin 2 countries
Study dates
Nov 2015to Nov 2016
Phase
Phase 3
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Adolescents between 12 to 18 years old must weigh >60 kg
  • Patients diagnosed with ABSSSI with at least one systemic sign of infection
  • Diagnosed with cellulitis, major cutaneous abscess, or wound infections (traumatic or surgical)
  • Surface redness, edema or induration must be of a minimum surface area of 75 cm2, or extending ≥5 cm from the peripheral margin of the abscess
  • Suspected or documented ABSSSI caused by a Gram-positive pathogen

Who cannot join

  • Involving a chronic diabetic foot infection (diabetic foot ulcer)
  • Involving burns
  • Involving an anatomical location (e.g. perirectal area) where the incidence of Gram-negative and/or anaerobic pathogen involvement is likely
  • Documented bacteremia associated with the current ABSSSI
  • Known severe renal impairment, as indicated by estimated CrCl <30 mL/min (by Cockcroft-Gault calculation)
  • Evidence of significant liver disease: ALT >3x ULN, or direct bilirubin >ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)

Trial locations and contacts

62 sites in 2 countries.

62 sites in 2 countries

United States60 sites

  • Study site

    Anaheim, California, 92804

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Baker, Louisiana, 70714

  • Study site

    Bakersfield, California, 93301

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Buena Park, California, 90620

  • Study site

    Butte, Montana, 59701

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Columbus, Georgia, 31904

  • Study site

    DeBary, Florida, 32713

  • Study site

    DeLand, Florida, 32720

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Doral, Florida, 33126

  • Study site

    Doral, Florida, 33166

  • Study site

    Eunice, Louisiana, 70535

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Gonzales, Texas, 78629

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77011

  • Study site

    Houston, Texas, 77084

  • Study site

    Houston, Texas, 77093

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    La Mesa, California, 91942

  • Study site

    La Palma, California, 90623

  • Study site

    Lancaster, South Carolina, 29720

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Long Beach, California, 90813

  • Study site

    Los Angeles, California, 90020

  • Study site

    Lutherville, Maryland, 21093

  • Study site

    Miami, Florida, 33015

  • Study site

    Miami, Florida, 33126

  • Study site

    Miami, Florida, 33144

  • Study site

    Miami, Florida, 33155

  • Study site

    Miami, Florida, 33175

  • Study site

    Miami Lakes, Florida, 33014

  • Study site

    Modesto, California, 95350

  • Study site

    National City, California, 91950

  • Study site

    Oceanside, California, 92056

  • Study site

    Orlando, Florida, 32806

  • Study site

    Philadelphia, Pennsylvania, 19103

  • Study site

    Rapid City, South Dakota, 57702

  • Study site

    Riverside, California, 92506

  • Study site

    Royal Oak, Michigan, 48703

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 89109

  • Study site

    San Diego, California, 91911

  • Study site

    San Diego, California, 91942

  • Study site

    San Diego, California, 92114

  • Study site

    San Diego, California, 92120

  • Study site

    San Dimas, California, 91773

  • Study site

    Savannah, Georgia, 31401

  • Study site

    Somers Point, New Jersey, 08244

  • Study site

    South Miami, Florida, 33143

  • Study site

    Splendora, Texas, 77372

  • Study site

    St Louis, Missouri, 63128

  • Study site

    Stockton, California, 95204

  • Study site

    Summerville, South Carolina, 29485

  • Study site

    Sylmar, California, 91342

  • Study site

    Teaneck, New Jersey, 07666

  • Study site

    West Palm Beach, Florida, 33401

Other trials in United States

Puerto Rico2 sites

  • Study site

    San Juan, 00909-3004

  • Study site

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Oral Sodium Fusidate (CEM-102) Compared to Oral Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infections

Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI

Read the detailed description

The primary objective is to demonstrate the non-inferiority of oral CEM-102 (loading dose regimen of 1500 mg every 12 hours for 2 doses, followed by 600 mg every 12 hours thereafter) compared to oral linezolid (600 mg every 12 hours), each administered for 10 days, for Early Clinical Response (ECR) in the intent to treat (ITT) analysis set in subjects with acute bacterial skin and skin structure infections (ABSSSI). Subjects with an ABSSSI caused by suspected or documented Gram-positive pathogen(s) at baseline will be randomized 1:1 to study treatment

Being tested
sodium fusidate, linezolid
Keywords
fusidic acid, skin infection
Medical subject headings
Cellulitis

What participants receive

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

  • sodium fusidateDrug

    Also called CEM-102

  • linezolidDrug

Study groups in NCT02570490
Study groupRoleWhat they receive
CEM-102 (Sodium fusidate)Experimental1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy (10 days total)
Receives: Drug: sodium fusidate
LinezolidActive comparator600 mg by mouth every 12 hours for 10 days
Receives: Drug: linezolid

What is being measured

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

  1. Proportion of subjects with a response for Early Clinical Response

    Proportion of subjects with a response for Early Clinical Response (ECR), defined as alive and achieved ≥ 20% reduction from baseline in the lesion size at 48-72 hours after start of study drug, without receipt of additional non-study antibiotic therapy.

    Measured: 48 to 72 hours after starting treatment

Secondary outcomes (2)

  1. Proportion of subjects with clinical success at Post-treatment Evaluation

    Proportion of subjects with clinical success at PTE, in the ITT and clinically evaluable (CE) analysis sets.

    Measured: 7 to 14 days after end of treatment

  2. Incidence of adverse events [Safety and tolerability], Clinical Laboratory Evaluations

    Incidence of adverse events, vital sign changes, physical exam changes, and clinical laboratory evaluations will be presented by study arm

    Measured: Up to 24 months

Timeline

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

  1. First posted7 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
716 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02570490
Sponsor's protocol ID
CE06-301
Status last verified
Jun 2017
First submitted
5 Oct 2015
Last updated
19 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sodium fusidate and linezolid in people with Acute Bacterial Skin and Skin Structure Infections, run by Arrevus Inc. at 62 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 5 inclusion and 6 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 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Proportion of subjects with a response for Early Clinical Response (time frame: 48 to 72 hours after starting treatment). 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 NCT02570490.

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 19 Apr 2019.

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