Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
NCT ID: NCT02569541
Last Updated: 2020-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2015-12-31
2019-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CEM-102 (Sodium fusidate)
1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy:
* 6 months of treatment; or
* 24 months of treatment (if continued on chronic suppressive therapy)
sodium fusidate
Interventions
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sodium fusidate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bone or joint infection due to an inclusionary pathogen demonstrated from a culture from samples obtained within 6 weeks prior to enrollment
* Not a candidate, as determined by the Investigator, for suitable alternative therapy
* After completion of 1-2 weeks of the companion antibiotic, must be a suitable candidate for CEM-102 monotherapy for chronic treatment
Exclusion Criteria
* Known severe renal impairment, as indicated by estimated CrCl \<30 mL/min (by Cockcroft-Gault calculation)
* Evidence of significant liver disease: ALT \>3 × ULN or direct bilirubin \>ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)
12 Years
ALL
No
Sponsors
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Arrevus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Dobbins, MD, PhD
Role: STUDY_DIRECTOR
Melinta Therapeutics, Inc.
Locations
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Fountain Valley, California, United States
San Dimas, California, United States
Sylmar, California, United States
Torrance, California, United States
Tamarac, Florida, United States
Springfield, Illinois, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Butte, Montana, United States
Somers Point, New Jersey, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Haverford, Pennsylvania, United States
Malvern, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CE06-302
Identifier Type: -
Identifier Source: org_study_id
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