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Article: Oritavancin Versus Daptomycin for Osteomyelitis Treatment After Surgical Debridement.

Van Hise, Nicholas W / Petrak, Russell M / Shah, Kairav / Diaz, Melina / Chundi, Vishnu / Redell, Mark

2024 Volume 13, Issue 3, Page(s) 535–547

Abstract: Introduction: Weekly intravenous (IV) oritavancin and daily daptomycin were compared in an outpatient setting following extensive surgical debridement for treating patients with osteomyelitis.: Methods: This was a retrospective, observational study ... ...

Abstract	Introduction: Weekly intravenous (IV) oritavancin and daily daptomycin were compared in an outpatient setting following extensive surgical debridement for treating patients with osteomyelitis. Methods: This was a retrospective, observational study of patients diagnosed with acute osteomyelitis. Exclusion criteria were the use of Gram-negative antibiotic therapy, use of antibiotics for more than 48 h prior to oritavancin or daptomycin or prior use of > 2 doses of oritavancin or more than 4 weeks of daptomycin. Clinical success was resolution or improvement of symptoms and no further treatment. Data were analyzed with Chi-square test or Fisher's exact test. Results: Consecutive outpatients (n = 150) with acute osteomyelitis who were treated with oritavancin or daptomycin (1:1) following extensive surgical debridement were identified. Staphylococcus aureus was the most common pathogen (n = 117). No patient in either group received prior antibiotic therapy (previous 30 days) or was hospitalized within 90 days prior to surgical debridement. Twenty-one (28%) patients prescribed oritavancin had chronic kidney disease, seven of whom were receiving hemodialysis or peritoneal dialysis. Compared to oritavancin, patients prescribed daptomycin had higher rates of all-cause readmission [odds ratio (OR) 2.89; p < 0.001], more infection-related readmission (OR 3.19; p < 0.001), and greater likelihood of receiving antibiotics post-discontinuation of initial therapy (OR 2.13; p < 0.001). Repeat surgical debridement was required for 68.0% with daptomycin vs. 23.1% with oritavancin (p < 0.001). Conclusions: Oritavancin demonstrated a significantly higher rate of clinical success compared to daptomycin, with lower all-cause and infection-related readmissions, reduced need for repeat surgical debridement, and fewer additional antibiotic requirements.
Language	English
Publishing date	2024-02-29
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2701611-0
ISSN	2193-6382 ; 2193-8229
ISSN (online)	2193-6382
ISSN	2193-8229
DOI	10.1007/s40121-024-00925-2
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Article: Treatment of Acute Osteomyelitis with Once-Weekly Oritavancin: A Two-Year, Multicenter, Retrospective Study.

Van Hise, Nicholas W / Chundi, Vishnu / Didwania, Vishal / Anderson, Michael / McKinsey, David / Roig, Ingrid / Sharma, Akhilesh / Petrak, Russell M

Drugs - real world outcomes

2020 Volume 7, Issue Suppl 1, Page(s) 41–45

Abstract: Background: Acute osteomyelitis is typically caused by Gram-positive pathogens, commonly antibiotic-resistant Staphylococcus species. Standard antibiotic treatment is challenging due to required multiple daily doses, therapeutic drug monitoring, and ... ...

Abstract	Background: Acute osteomyelitis is typically caused by Gram-positive pathogens, commonly antibiotic-resistant Staphylococcus species. Standard antibiotic treatment is challenging due to required multiple daily doses, therapeutic drug monitoring, and parenteral administration for at least 4 weeks. Oritavancin is a long-acting lipoglycopeptide antibiotic approved as a single 1200 mg dose for the treatment of adult patients with acute bacterial skin and skin structure infections. Objective: To characterize the real-world use, efficacy, and safety of oritavancin in adult patients with acute osteomyelitis. Methods: This was a 2-year, multicenter, retrospective, descriptive study of patients treated for acute osteomyelitis with weekly doses of oritavancin. End of therapy evaluation (ETE) was defined as evaluation at 7-10 days after the last dose of oritavancin, and post-therapy assessment (PTE) was at 3 months and 6 months. At ETE and PTE, patients were interviewed via telephone for clinical outcomes, using a standard questionnaire. Electronic medical record review was also conducted. Results: 134 patients were treated with oritavancin for acute osteomyelitis across 20 different Metro Infectious Disease Consultants infusion centers in six states. Of total positive cultures, 71.9% (92/128) were methicillin-resistant Staphylococcus aureus (MRSA) from deep wounds, bone, or joint culture; an additional nine (6.7%) of 134 patients presented with concomitant MRSA bacteremia. Oritavancin was administered via intravenous catheter; patients received an initial treatment of 1200 mg and then 800 mg weekly thereafter for a total number of doses of four (n = 118) or five (n = 16). 118 patients (88.1%) of the baseline 134 patients achieved clinical success at the ETE timepoint. 130 patients were available for PTE at 3 months and 6 months. Overall, relapse or persistent infection was diagnosed in 13/134 (9.7%) patients. Nine (6.7%) of 134 patients were admitted to the hospital during the follow-up period but none for osteomyelitis. Adverse events were reported in five (3.7%) patients including hypoglycemia-related symptoms (three patients), tachycardia (one patient), and tachycardia with chest pain (one patient). None of these patients were hospitalized due to adverse events, and all patients eventually finished their treatment regimens. Conclusion: This is the largest real-world clinical study of adult patients treated with oritavancin for acute osteomyelitis. Use of oritavancin for acute osteomyelitis infection resulted in a high rate of positive clinical outcomes and a low incidence of adverse events, thereby providing potential for a convenient, effective, and safe therapeutic option. Future prospective and comparative studies are needed to validate these findings.
Language	English
Publishing date	2020-06-26
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2806600-5
ISSN	2198-9788 ; 2199-1154
ISSN (online)	2198-9788
ISSN	2199-1154
DOI	10.1007/s40801-020-00195-7
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Article ; Online: Early Tocilizumab Dosing Is Associated With Improved Survival in Critically Ill Patients Infected With Severe Acute Respiratory Syndrome Coronavirus-2.

Petrak, Russell M / Van Hise, Nicholas W / Skorodin, Nathan C / Fliegelman, Robert M / Chundi, Vishnu / Didwania, Vishal / Han, Alice / Harting, Brian P / Hines, David W

Critical care explorations

2021 Volume 3, Issue 4, Page(s) e0395

Abstract: To identify the most efficacious timing for tocilizumab administration in critically ill patients infected with severe acute respiratory syndrome coronavirus-2.: Design: Observational multicenter cohort study.: Setting: A total of 23 acute care ... ...

Abstract	To identify the most efficacious timing for tocilizumab administration in critically ill patients infected with severe acute respiratory syndrome coronavirus-2. Design: Observational multicenter cohort study. Setting: A total of 23 acute care hospitals in four states. Patients: One-hundred eighteen patients admitted between March 13, 2020, and April 16, 2020. Eighty-one patients received tocilizumab, and 37 were untreated and served as a control group. Measurements and main results: The main outcome was mortality and was analyzed by timing of tocilizumab dosing. Early dosing was defined as a tocilizumab dose administered prior to or within 1 day of intubation. Late dosing was defined as a dose administered greater than 1 day after intubation. A control group that was treated only with standard of care, and without tocilizumab, was used for comparison. Early tocilizumab therapy was associated with a statistically significant decrease in mortality as compared to patients who were untreated ( Conclusions: Early tocilizumab administration was associated with decreased mortality in critically ill severe acute respiratory syndrome coronavirus-2 patients, but a potential detriment was suggested by dosing later in a patient's course.
Language	English
Publishing date	2021-03-29
Publishing country	United States
Document type	Journal Article
ISSN	2639-8028
ISSN (online)	2639-8028
DOI	10.1097/CCE.0000000000000395
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Article: A Real-World Assessment of Clinical Outcomes and Safety of Eravacycline: A Novel Fluorocycline.

Van Hise, Nicholas / Petrak, Russell M / Skorodin, Nathan C / Fliegelman, Robert M / Anderson, Michael / Didwania, Vishal / Han, Alice / Shah, Kairav / Chundi, Vishnu / Hines, David / Roig, Ingrid / Kalra, Apoorv

Infectious diseases and therapy

2020 Volume 9, Issue 4, Page(s) 1017–1028

Abstract: Background: Eravacycline is a novel fluorocycline approved for treatment of intraabdominal infections, with a broad spectrum of activity against a range of pathogens including multidrug-resistant species, including ESBL- or KPC-producing isolates. It is ...

Abstract	Background: Eravacycline is a novel fluorocycline approved for treatment of intraabdominal infections, with a broad spectrum of activity against a range of pathogens including multidrug-resistant species, including ESBL- or KPC-producing isolates. It is approved for twice-daily dosing with no need for adjustment in renal dysfunction. In the concomitant administration with CYP 3A4-inducing drugs, eravacycline dosing should be modified. Objective: To evaluate the efficacy and safety of eravacycline in a range of infections such as intraabdominal infections, pneumonia and diabetic foot infections in seriously ill patients. Methods: A retrospective observational cohort study using electronic patient records of 50 consecutive patients administered eravacycline during inpatient acute care admission or as part of outpatient antibiotic therapy (OPAT). Results: Therapy of 1.5 mg/kg q24h was initiated in the hospital in most patients, although some of the less sick were managed in the office or OPAT setting. All patients concluded their management outside of the hospital. Of the 50 patients, 47 (94%) achieved clinical resolution of their infection and 3 (6%) clinical failures occurred. Only three (6%) patients did not have comorbidities, three had a single comorbidity (6%), and the majority (88%) of patients had two or more comorbidities. Most common infections were intraabdominal (36%), pneumonia (18%), diabetic foot (12%), spontaneous bacterial peritonitis (8%) and empyema (8%). Almost half of infections had more than one pathogen isolated, and resistant isolates were frequent. The drug was well tolerated with only two reports of nausea, which did not result in treatment discontinuation, and in 30 days of post-eravacycline therapy only one case of Clostridiodes difficile. Conclusions: In this real-world setting, eravacycline demonstrated a similar high level of clinical efficacy as seen in clinical trials, 94%, in a variety of infections, including against multidrug-resistant bacteria, and was well tolerated.
Language	English
Publishing date	2020-10-15
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2701611-0
ISSN	2193-6382 ; 2193-8229
ISSN (online)	2193-6382
ISSN	2193-8229
DOI	10.1007/s40121-020-00351-0
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Article: Value and Clinical Impact of an Infectious Disease-Supervised Outpatient Parenteral Antibiotic Therapy Program.

Petrak, Russell M / Skorodin, Nathan C / Fliegelman, Robert M / Hines, David W / Chundi, Vishnu V / Harting, Brian P

Open forum infectious diseases

2016 Volume 3, Issue 4, Page(s) ofw193

Abstract: Background. ...

Abstract	Background.
Language	English
Publishing date	2016-10-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofw193
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Article ; Online: Tocilizumab as a Therapeutic Agent for Critically Ill Patients Infected with SARS-CoV-2.

Petrak, Russell M / Skorodin, Nathan C / Van Hise, Nicholas W / Fliegelman, Robert M / Pinsky, Jonathan / Didwania, Vishal / Anderson, Michael / Diaz, Melina / Shah, Kairav / Chundi, Vishnu V / Hines, David W / Harting, Brian P / Sidwha, Kamo / Yu, Brian / Brune, Paul / Owaisi, Anjum / Beezhold, David / Kent, Joseph / Vais, Dana /

Han, Alice / Gowda, Neethi / Sahgal, Nishi / Silverman, Jan / Stake, Jonathan / Nepomuceno, Jenie / Heddurshetti, Renuka

Clinical and translational science

2021 Volume 14, Issue 6, Page(s) 2146–2151

Abstract: Tocilizumab is an IL-6 receptor antagonist with the ability to suppress the cytokine storm in critically ill patients infected with severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). We evaluated patients treated with tocilizumab for a SARS- ... ...

Abstract	Tocilizumab is an IL-6 receptor antagonist with the ability to suppress the cytokine storm in critically ill patients infected with severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). We evaluated patients treated with tocilizumab for a SARS-CoV-2 infection who were admitted between March 13, 2020, and April 16, 2020. This was a multicenter study with data collected by chart review both retrospectively and concurrently. Parameters evaluated included age, sex, race, use of mechanical ventilation (MV), usage of steroids and vasopressors, inflammatory markers, and comorbidities. Early dosing was defined as a tocilizumab dose administered prior to or within 1 day of intubation. Late dosing was defined as a dose administered > 1 day after intubation. In the absence of MV, the timing of the dose was related to the patient's date of admission only. We evaluated 145 patients. The average age was 58.1 years, 64% were men, 68.3% had comorbidities, and 60% received steroid therapy. Disposition of patients was 48.3% discharged and 29.3% died, of which 43.9% were African American. MV was required in 55.9%, of which 34.5% died. Avoidance of MV (P = 0.002) and increased survival (P < 0.001) was statistically associated with early dosing. Tocilizumab therapy was effective at decreasing mortality and should be instituted early in the management of critically ill patients with coronavirus disease 2019) COVID-19).
MeSH term(s)	Antibodies, Monoclonal, Humanized/therapeutic use ; COVID-19/drug therapy ; COVID-19/immunology ; COVID-19/mortality ; COVID-19/therapy ; COVID-19/virology ; Critical Illness/mortality ; Critical Illness/therapy ; Cytokine Release Syndrome/immunology ; Cytokine Release Syndrome/mortality ; Cytokine Release Syndrome/therapy ; Cytokine Release Syndrome/virology ; Female ; Hospital Mortality ; Humans ; Male ; Middle Aged ; Respiration, Artificial/statistics & numerical data ; Retrospective Studies ; SARS-CoV-2/immunology ; Severity of Illness Index ; Time Factors ; Time-to-Treatment ; Treatment Outcome
Chemical Substances	Antibodies, Monoclonal, Humanized ; tocilizumab (I031V2H011)
Keywords	covid19
Language	English
Publishing date	2021-10-27
Publishing country	United States
Document type	Journal Article ; Multicenter Study
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.12894
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Article ; Online: 2018 Infectious Diseases Society of America Clinical Practice Guideline for the Management of Outpatient Parenteral Antimicrobial Therapy.

Norris, Anne H / Shrestha, Nabin K / Allison, Genève M / Keller, Sara C / Bhavan, Kavita P / Zurlo, John J / Hersh, Adam L / Gorski, Lisa A / Bosso, John A / Rathore, Mobeen H / Arrieta, Antonio / Petrak, Russell M / Shah, Akshay / Brown, Richard B / Knight, Shandra L / Umscheid, Craig A

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2018 Volume 68, Issue 1, Page(s) 1–4

Abstract: A panel of experts was convened by the Infectious Diseases Society of America to update the 2004 clinical practice guideline on outpatient parenteral antimicrobial therapy (OPAT) [1]. This guideline is intended to provide insight for healthcare ... ...

Abstract	A panel of experts was convened by the Infectious Diseases Society of America to update the 2004 clinical practice guideline on outpatient parenteral antimicrobial therapy (OPAT) [1]. This guideline is intended to provide insight for healthcare professionals who prescribe and oversee the provision of OPAT. It considers various patient features, infusion catheter issues, monitoring questions, and antimicrobial stewardship concerns. It does not offer recommendations on the treatment of specific infections. The reader is referred to disease- or organism-specific guidelines for such support.
MeSH term(s)	Administration, Intravenous/methods ; Americas ; Anti-Infective Agents/administration & dosage ; Communicable Diseases/drug therapy ; Drug Therapy/methods ; Drug Utilization/standards ; Humans ; Injections/methods ; Outpatients
Chemical Substances	Anti-Infective Agents
Language	English
Publishing date	2018-12-13
Publishing country	United States
Document type	Journal Article ; Practice Guideline ; Research Support, Non-U.S. Gov't
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciy867
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Article ; Online: 2018 Infectious Diseases Society of America Clinical Practice Guideline for the Management of Outpatient Parenteral Antimicrobial Therapy.

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2018 Volume 68, Issue 1, Page(s) e1–e35

Abstract: A panel of experts was convened by the Infectious Diseases Society of America (IDSA) to update the 2004 clinical practice guideline on outpatient parenteral antimicrobial therapy (OPAT) [1]. This guideline is intended to provide insight for healthcare ... ...

Abstract	A panel of experts was convened by the Infectious Diseases Society of America (IDSA) to update the 2004 clinical practice guideline on outpatient parenteral antimicrobial therapy (OPAT) [1]. This guideline is intended to provide insight for healthcare professionals who prescribe and oversee the provision of OPAT. It considers various patient features, infusion catheter issues, monitoring questions, and antimicrobial stewardship concerns. It does not offer recommendations on the treatment of specific infections. The reader is referred to disease- or organism-specific guidelines for such support.
MeSH term(s)	Administration, Intravenous/methods ; Americas ; Anti-Infective Agents/administration & dosage ; Communicable Diseases/drug therapy ; Drug Therapy/methods ; Drug Utilization/standards ; Humans ; Injections/methods ; Outpatients ; Practice Guidelines as Topic
Chemical Substances	Anti-Infective Agents
Language	English
Publishing date	2018-11-13
Publishing country	United States
Document type	Journal Article ; Practice Guideline ; Research Support, Non-U.S. Gov't
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciy745
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Tocilizumab as a Therapeutic Agent for Critically Ill Patients Infected with SARS‐CoV‐2

Petrak, Russell M. / Skorodin, Nathan C. / Van Hise, Nicholas W. / Fliegelman, Robert M. / Pinsky, Jonathan / Didwania, Vishal / Anderson, Michael / Diaz, Melina / Shah, Kairav / Chundi, Vishnu V. / Hines, David W. / Harting, Brian P. / Sidwha, Kamo / Yu, Brian / Brune, Paul / Owaisi, Anjum / Beezhold, David / Kent, Joseph / Vais, Dana /

Han, Alice / Gowda, Neethi / Sahgal, Nishi / Silverman, Jan / Stake, Jonathan / Nepomuceno, Jenie / Heddurshetti, Renuka

Clinical and Translational Science ; ISSN 1752-8054 1752-8062

2020

Keywords	General Pharmacology, Toxicology and Pharmaceutics ; General Biochemistry, Genetics and Molecular Biology ; General Neuroscience ; General Medicine ; covid19
Language	English
Publisher	Wiley
Publishing country	us
Document type	Article ; Online
DOI	10.1111/cts.12894
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Tocilizumab as a Therapeutic Agent for Critically Ill Patients Infected with SARS‐CoV‐2

Russell M. Petrak / Nathan C. Skorodin / Nicholas W. Van Hise / Robert M. Fliegelman / Jonathan Pinsky / Vishal Didwania / Michael Anderson / Melina Diaz / Kairav Shah / Vishnu V. Chundi / David W. Hines / Brian P. Harting / Kamo Sidwha / Brian Yu / Paul Brune / Anjum Owaisi / David Beezhold / Joseph Kent / Dana Vais /

Alice Han / Neethi Gowda / Nishi Sahgal / Jan Silverman / Jonathan Stake / Jenie Nepomuceno / Renuka Heddurshetti

Clinical and Translational Science, Vol 14, Iss 6, Pp 2146-

2021 Volume 2151

Abstract: Tocilizumab is an IL‐6 receptor antagonist with the ability to suppress the cytokine storm in critically ill patients infected with severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2). We evaluated patients treated with tocilizumab for a SARS‐ ... ...

Abstract	Tocilizumab is an IL‐6 receptor antagonist with the ability to suppress the cytokine storm in critically ill patients infected with severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2). We evaluated patients treated with tocilizumab for a SARS‐CoV‐2 infection who were admitted between March 13, 2020, and April 16, 2020. This was a multicenter study with data collected by chart review both retrospectively and concurrently. Parameters evaluated included age, sex, race, use of mechanical ventilation (MV), usage of steroids and vasopressors, inflammatory markers, and comorbidities. Early dosing was defined as a tocilizumab dose administered prior to or within 1 day of intubation. Late dosing was defined as a dose administered > 1 day after intubation. In the absence of MV, the timing of the dose was related to the patient’s date of admission only. We evaluated 145 patients. The average age was 58.1 years, 64% were men, 68.3% had comorbidities, and 60% received steroid therapy. Disposition of patients was 48.3% discharged and 29.3% died, of which 43.9% were African American. MV was required in 55.9%, of which 34.5% died. Avoidance of MV (P = 0.002) and increased survival (P < 0.001) was statistically associated with early dosing. Tocilizumab therapy was effective at decreasing mortality and should be instituted early in the management of critically ill patients with coronavirus disease 2019) COVID‐19).
Keywords	Therapeutics. Pharmacology ; RM1-950 ; Public aspects of medicine ; RA1-1270
Subject code	610 ; 616
Language	English
Publishing date	2021-11-01T00:00:00Z
Publisher	Wiley
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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