A Phase 2/3 interventional study of sodium fusidate in Refractory Bone or Joint Infections, sponsored by Arrevus Inc.. Completed at 19 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-01-30.
Sponsored by Arrevus Inc. · Phase 2/3, Interventional, and Treatment
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
Prospective, open-label, non-randomized, single-arm trial to evaluate the safety and effectiveness of CEM-102 for chronic antibiotic suppressive therapy of bone or joint infections. Subjects enrolling in this study must have a refractory staphylococcal bone or joint infection that requires suppressive antibiotic therapy (e.g. having an infection that cannot be managed by complete removal of the infected bone or foreign material, a refractory infection not responding to previous treatment, or not being a candidate for long-term intravenous antibiotic therapy).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 30 is below the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Arrevus Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Drug: sodium fusidate
Also known as: CEM-102, fusidic acid
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
Time frame: 6 months after start of treatment
Safety and Tolerability
Number of participants with TEAEs, SAEs, deaths, and discontinuations due to AEs. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
Time frame: Entire study period - up to 24 months
Clinical Success at 9 Months
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 9-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
Time frame: 9 months after start of treatment
Clinical Success at 12 Months
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 12-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
Time frame: 12 months after start of treatment
Clinical Success at 15 Months
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 15-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
Time frame: 15 months after start of treatment
Clinical Success at 18 Months
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 18-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
Time frame: 18 months after start of treatment
Clinical Success at 21 Months
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 21-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
Time frame: 21 months after start of treatment
Clinical Success at 24 Months
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 24-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
Time frame: 24 months after start of treatment
| Milestone | CEM-102 (Sodium Fusidate) |
|---|---|
| Started | 30 |
| Completed | 9 |
| Not completed | 21 |
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
| Participants | CEM-102 (Sodium Fusidate) |
|---|---|
| Clinical Success | 18 |
| Clinical Failure | 9 |
| Indeterminate | 3 |
Number of participants with TEAEs, SAEs, deaths, and discontinuations due to AEs. Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported.
| Participants | CEM-102 (Sodium Fusidate) |
|---|---|
| Treatment Emergent AE (TEAE) | 29 |
| Severe TEAE | 12 |
| TEAE Related to Study Drug | 7 |
| TEAE Leading to Study Discontinuation | 9 |
| TEAE Leading to Study Drug Discontinuation | 12 |
| TE Serious Adverse Event (SAE) | 15 |
| TE SAE with outcome of death | 0 |
| TE SAE Related to Study Drug | 0 |
| TE SAE Leading to Study Discontinuation | 7 |
| TE SAE Leading to Study Drug Discontinuation | 9 |
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 9-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
| Participants | CEM-102 (Sodium Fusidate) |
|---|---|
| Clinical Success | 15 |
| Clinical Failure | 11 |
| Indeterminate | 4 |
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 12-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
| Participants | CEM-102 (Sodium Fusidate) |
|---|---|
| Clinical Success | 10 |
| Clinical Failure | 15 |
| Indeterminate | 5 |
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 15-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
| Participants | CEM-102 (Sodium Fusidate) |
|---|---|
| Clinical Success | 8 |
| Clinical Failure | 17 |
| Indeterminate | 5 |
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 18-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
| Participants | CEM-102 (Sodium Fusidate) |
|---|---|
| Clinical Success | 8 |
| Clinical Failure | 16 |
| Indeterminate | 6 |
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 21-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
| Participants | CEM-102 (Sodium Fusidate) |
|---|---|
| Clinical Success | 6 |
| Clinical Failure | 17 |
| Indeterminate | 7 |
Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 24-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
| Participants | CEM-102 (Sodium Fusidate) |
|---|---|
| Clinical Success | 7 |
| Clinical Failure | 17 |
| Indeterminate | 6 |
Collected over 24 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CEM-102 (Sodium Fusidate) | 0/30 (0%) | 15/30 (50%) | 27/30 (90%) |
| Event | CEM-102 (Sodium Fusidate) |
|---|---|
| Device related infectionInfections and infestations | 4/30 |
| Cardiac failure congestiveCardiac disorders | 3/30 |
| Atrial fibrillationCardiac disorders | 2/30 |
| SyncopeNervous system disorders | 2/30 |
| BradycardiaCardiac disorders | 1/30 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/30 |
| Arthritis infectiveInfections and infestations | 1/30 |
| DiverticulitisInfections and infestations | 1/30 |
| PneumoniaInfections and infestations | 1/30 |
| PyelonephritisInfections and infestations | 1/30 |
| Event | CEM-102 (Sodium Fusidate) |
|---|---|
| Urinary tract infectionInfections and infestations | 9/30 |
| AnaemiaBlood and lymphatic system disorders | 4/30 |
| NauseaGastrointestinal disorders | 4/30 |
| Oedema peripheralGeneral disorders | 4/30 |
| Peripheral swellingGeneral disorders | 4/30 |
| PyrexiaGeneral disorders | 4/30 |
| DyspepsiaGastrointestinal disorders | 3/30 |
| HypokalemiaMetabolism and nutrition disorders | 3/30 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/30 |
| Vision blurredEye disorders | 2/30 |
Intent-to-Treat (ITT) Population included all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.
| Age, Continuous(years) | CEM-102 (Sodium Fusidate) |
|---|---|
| Mean | 61 ± 13.4 |
| Sex: Female, Male(Participants) | CEM-102 (Sodium Fusidate) |
|---|---|
| Female | 10 |
| Male | 20 |
| Ethnicity (NIH/OMB)(Participants) | CEM-102 (Sodium Fusidate) |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 28 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | CEM-102 (Sodium Fusidate) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 27 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | CEM-102 (Sodium Fusidate) |
|---|---|
| United States | 30 |
| Height(cm) | CEM-102 (Sodium Fusidate) |
|---|---|
| Mean | 174.5 ± 11.54 |
| Weight(kg) | CEM-102 (Sodium Fusidate) |
|---|---|
| Mean | 87.4 ± 22.12 |
| BMI(kg/m2) | CEM-102 (Sodium Fusidate) |
|---|---|
| Mean | 28.7 ± 6.79 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Arrevus Inc.