Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
An Open-Label, Non-Randomized, Single-Arm, Multi-Center Study to Evaluate Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections in Subjects for Whom Chronic Antibiotic Suppressive Therapy is Indicated
1 other identifier
interventional
30
1 country
19
Brief Summary
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2015
Typical duration for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 6, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2019
CompletedResults Posted
Study results publicly available
January 30, 2020
CompletedJanuary 30, 2020
January 1, 2020
1.9 years
October 5, 2015
January 9, 2020
January 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Success at 6 Months
Number of participants in the intent to treat (ITT) analysis set who meet all the criteria for clinical success at the 6-Month Visit. Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia
6 months after start of treatment
Secondary Outcomes (7)
Safety and Tolerability
Entire study period - up to 24 months
Clinical Success at 9 Months
9 months after start of treatment
Clinical Success at 12 Months
12 months after start of treatment
Clinical Success at 15 Months
15 months after start of treatment
Clinical Success at 18 Months
18 months after start of treatment
- +2 more secondary outcomes
Study Arms (1)
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: * 6 months of treatment; or * 24 months of treatment (if continued on chronic suppressive therapy)
Interventions
Eligibility Criteria
You may qualify if:
- Adolescents between 12 and 18 years must weigh \>60 kg
- 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
You may not qualify if:
- Requires concomitant treatment with OATP1B1 and OATP1B3 substrates, in particular, statins (HMG-CoA reductase inhibitors)
- Known severe renal impairment, as indicated by estimated CrCl \<30 mL/min (by Cockcroft-Gault calculation)
- Evidence of significant liver disease: ALT \>3 Ă— ULN or direct bilirubin \>ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arrevus Inc.lead
Study Sites (19)
Unknown Facility
Fountain Valley, California, 92708, United States
Unknown Facility
San Dimas, California, 91773, United States
Unknown Facility
Sylmar, California, 91432, United States
Unknown Facility
Torrance, California, 90502, United States
Unknown Facility
Tamarac, Florida, 33321, United States
Unknown Facility
Springfield, Illinois, 62703, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Baltimore, Maryland, 21218, United States
Unknown Facility
Boston, Massachusetts, 02111, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Butte, Montana, 59701, United States
Unknown Facility
Somers Point, New Jersey, 08244, United States
Unknown Facility
Charlotte, North Carolina, 28207, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Haverford, Pennsylvania, 19041, United States
Unknown Facility
Malvern, Pennsylvania, 19355, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carl Kraus, MD (CEO)
- Organization
- Arrevus, Inc.
Study Officials
- STUDY DIRECTOR
Robert Dobbins, MD, PhD
Melinta Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 6, 2015
Study Start
December 1, 2015
Primary Completion
October 17, 2017
Study Completion
February 21, 2019
Last Updated
January 30, 2020
Results First Posted
January 30, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share