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| ID | Type | Description | Link |
|---|---|---|---|
| DAP-OST-06-02 | Other Identifier | Cubist Study Number |
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This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daptomycin 6 mg/kg | Experimental | Daptomycin (6 mg/kg every 24 hours [q24h]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week). |
|
| Daptomycin 8 mg/kg | Experimental | Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week). |
|
| Comparator | Active Comparator | Vancomycin was administered at 1 gram every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daptomycin | Drug | 6 mg/kg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L) | Number of subjects with CPK >500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory. | From the 3rd day of therapy to 1 week post last dose (approximately week 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Notable Laboratory Abnormalities | Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range. | From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alistair Wheeler, MD | Cubist Pharmaceuticals, 65 Hayden Ave, Lexington, MA 02421, USA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS College of Medicine | Little Rock | Arkansas | 72205-7199 | United States | ||
| South Denver Infectious Disease Associates, PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22908174 | Derived | Byren I, Rege S, Campanaro E, Yankelev S, Anastasiou D, Kuropatkin G, Evans R. Randomized controlled trial of the safety and efficacy of Daptomycin versus standard-of-care therapy for management of patients with osteomyelitis associated with prosthetic devices undergoing two-stage revision arthroplasty. Antimicrob Agents Chemother. 2012 Nov;56(11):5626-32. doi: 10.1128/AAC.00038-12. Epub 2012 Aug 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daptomycin 6 mg/kg | Daptomycin (6 mg/kg every 24 hours [q24h]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week). |
| FG001 | Daptomycin 8 mg/kg | Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Completed Study Drug Treatment |
|
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| daptomycin |
| Drug |
8 mg/kg |
|
|
| vancomycin | Drug | 1 gram |
|
|
| teicoplanin | Drug | 6 mg/kg; used only at UK sites |
|
|
| nafcillin | Drug | 1-2 gram |
|
|
| oxacillin | Drug | 1-2 gram |
|
|
| flucloxacillin | Drug | 1-2 mg |
|
|
| Overall Clinical Outcome |
The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable. |
| Approximately 6 weeks post last dose (approximately week 12) |
| Microbiological Response | Sponsor's assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population. | Approximately 6 weeks post last dose (approximately week 12) |
| Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) | The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion. | Day 4 (steady state) |
| Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss) | The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion. | Day 4 (steady state) |
| Englewood |
| Colorado |
| 80133 |
| United States |
| Kane and Davis Associates | Washington D.C. | District of Columbia | 20016 | United States |
| Infectious Disease Association of Tampa Bay | Tampa | Florida | 33606 | United States |
| Idaho Falls Infectious Diseases, PLLC | Idaho Falls | Idaho | 83404 | United States |
| Rush St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62794 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Sierra Infectious Disease | Reno | Nevada | 89502 | United States |
| Dartmouth-Hitchcock Medical center | Lebanon | New Hampshire | 03756 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Summa Health Systems | Akron | Ohio | 44304 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Regional Infectious Diseases-Infusion Center | Lima | Ohio | 45801 | United States |
| Lehigh Valley Hospital Trauma and Critical Care Research | Allentown | Pennsylvania | 18103 | United States |
| Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Gundersen Clinic, LTD | La Crosse | Wisconsin | 54601 | United States |
| Federal National Institution of Science "Russian Ilizarov Scientific Center" "Restorative Traumatology and Orthopedics" of Rosmedtechnology | Kurgan | 640014 | Russia |
| National Healthcare Institution of Moscow "City Clinical Hospital #64" | Moscow | 117292 | Russia |
| Federal Healthcare Institute "Novosibirsk Scientific Research Institute of Traumatology and Orthopedy Rosmeditechnology" | Novosibirsk | 630091 | Russia |
| National Educational Institution of Higher Professional Education "Saint Petersburg State Medical Academy n.a. Mechnikov of Roszdrav" | Saint Petersburg | 195067 | Russia |
| Russian Research Institute of Traumatology and Orthopedy | Saint Petersburg | 197046 | Russia |
| National Healthcare Institution "Samara Regional Clinical Hospital n.a. Kalinin" | Samara | 443095 | Russia |
| Nuffield Orthopaedics Centre, Bone Infection Unit | Headington, Oxford | Oxfordshire | OX37LD | United Kingdom |
| The Royal Infirmary of Edinburgh at Little France | Edinburgh | Scotland | EH164SA | United Kingdom |
| Brownlee Centre - Gartnavel General Hospital | Glasgow | Scotland | G120YN | United Kingdom |
| FG002 | Comparator | Vancomycin was administered at 1 gram (gm)every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week). |
| Received First Dose |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Completed Test of Cure (TOC) Visit |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Daptomycin 6 mg/kg | Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week). |
| BG001 | Daptomycin 8 mg/kg | Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week). |
| BG002 | Comparator | Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Safety/Intent to Treat Population (1 patient included in the Overall Number of Baseline Participants was randomized to comparator but not treated) | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Safety/Intent to Treat Population (1 patient included in the Overall Number of Baseline Participants was randomized to comparator but not treated) | 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 | Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L) | Number of subjects with CPK >500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory. | Safety Population | Posted | Number | Participants | From the 3rd day of therapy to 1 week post last dose (approximately week 7) |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Safety - Notable Laboratory Abnormalities | Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range. | Safety Population | Posted | Number | Participants | From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Clinical Outcome | The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable. | Modified Intent-to-Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection. | Posted | Number | Participants | Approximately 6 weeks post last dose (approximately week 12) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Microbiological Response | Sponsor's assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population. | Modified Intent to Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection. | Posted | Number | Participants | Approximately 6 weeks post last dose (approximately week 12) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) | The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion. | Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group. | Posted | Median | Full Range | µg/mL | Day 4 (steady state) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss) | The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion. | Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group. | Posted | Median | Full Range | µg•hr/mL | Day 4 (steady state) |
|
|
From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daptomycin 6 mg/kg | Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week). | 8 | 25 | 23 | 25 | ||
| EG001 | Daptomycin 8 mg/kg | Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week). | 4 | 24 | 18 | 24 | ||
| EG002 | Comparator | Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week). | 8 | 25 | 22 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Wound necrosis | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Device dislocation | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Dislocation of joint prosthesis | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
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| Arthritis infective | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
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| Urine output decreased | Investigations | MedDRA 9.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
The first publication is initiated by Cubist. If first publication not published within 1 year of study conclusion or termination, Investigator has right to publish and disclose the Data. Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Cubist at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ed Campanaro, VP Clinical Operations | Cubist Pharmaceuticals, Inc. | 781-860-8318 | ed.campanaro@cubist.com |
| ID | Term |
|---|---|
| D010019 | Osteomyelitis |
| ID | Term |
|---|---|
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017576 | Daptomycin |
| D014640 | Vancomycin |
| D017334 | Teicoplanin |
| D009254 | Nafcillin |
| D010068 | Oxacillin |
| D005436 | Floxacillin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D000077427 | Lipoglycopeptides |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003023 | Cloxacillin |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Microbiologic failure |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|