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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEM-102 (Sodium fusidate) | Experimental | 1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium fusidate | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Entire study period - up to 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Dobbins, MD, PhD | Melinta Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fountain Valley | California | 92708 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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:
sodium fusidate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2017 |
Not provided
Not provided
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| 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 |
| 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 | 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 | 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 | 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 | 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 | 24 months after start of treatment |
| San Dimas |
| California |
| 91773 |
| United States |
| Sylmar | California | 91432 | United States |
| Torrance | California | 90502 | United States |
| Tamarac | Florida | 33321 | United States |
| Springfield | Illinois | 62703 | United States |
| Louisville | Kentucky | 40202 | United States |
| Baltimore | Maryland | 21218 | United States |
| Boston | Massachusetts | 02111 | United States |
| Detroit | Michigan | 48202 | United States |
| Butte | Montana | 59701 | United States |
| Somers Point | New Jersey | 08244 | United States |
| Charlotte | North Carolina | 28207 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cleveland | Ohio | 44195 | United States |
| Haverford | Pennsylvania | 19041 | United States |
| Malvern | Pennsylvania | 19355 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Houston | Texas | 77030 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Intent-to-Treat (ITT) Population included all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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:
sodium fusidate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m2 |
| ||||||||||||||||||||||
| Infection Type and Location | Count of Participants | Participants |
| |||||||||||||||||||||||
| Risk Factors for BJI | Count of Participants | Participants |
| |||||||||||||||||||||||
| Baseline Pathogen | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study. | Posted | Count of Participants | Participants | 6 months after start of treatment |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety population - all enrolled subjects who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Entire study period - up to 24 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study. | Posted | Count of Participants | Participants | 9 months after start of treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study. | Posted | Count of Participants | Participants | 12 months after start of treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study. | Posted | Count of Participants | Participants | 15 months after start of treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study. | Posted | Count of Participants | Participants | 18 months after start of treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study. | Posted | Count of Participants | Participants | 21 months after start of treatment |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study. | Posted | Count of Participants | Participants | 24 months after start of treatment |
|
|
24 months
Adverse events are reported for members of the Safety Population, comprised of enrolled subjects who received at least 1 dose of study drug. 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
sodium fusidate | 0 | 30 | 15 | 30 | 27 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA V18.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA V18.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA V18.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V18.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA V18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V18.1 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA V18.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA V18.1 | Non-systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA V18.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Yellow nail syndrome | Skin and subcutaneous tissue disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Abscess drainage | Surgical and medical procedures | MedDRA V18.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA V18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA V18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V18.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA V18.1 | Non-systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA V18.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA V18.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V18.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA V18.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA V18.1 | Non-systematic Assessment |
|
The Sponsor has the right to first publication of results, which would be made in conjunction with the PIs from all appropriate sites. Thereafter, PIs may publish results provided the PI submits the proposed publication to the Sponsor for review at least 60 days prior to the date of the proposed publication. The Sponsor may remove information that is considered confidential and/or proprietary and delay the proposed publication for an additional 60 days to enable filing of patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carl Kraus, MD (CEO) | Arrevus, Inc. | 9193665503 | ckraus@arrevus.com |
| Jan 9, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010019 | Osteomyelitis |
| ID | Term |
|---|---|
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005672 | Fusidic Acid |
| ID | Term |
|---|---|
| D002775 | Cholestadienols |
| D002774 | Cholestadienes |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Prosthetic joint infection - knee |
|
| Prosthetic joint infection - hip |
|
| Prosthetic joint infection - shoulder |
|
| Prosthetic joint infection - other |
|
| Other orthopedic hardware |
|
| Decubitis ulcers from Immobility |
|
| Previous PJI in Another Anatomical Location |
|
| Staphylococcus epidermidis |
|
| coagulase-negative Staphylococcus |
|
| Corynebacterium striatum/simulans |
|
| Cutibacterium acnes |
|
| Streptococcus agalactiae |
|
| Title | Measurements |
|---|---|
|
|
| Participants |
|
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| Participants |
|
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| Participants |
|
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| Participants |
|
|
| Participants |
|
|
| Participants |
|
|