The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections

Mark Redell; Miguel Sierra-Hoffman; Maha Assi; Markian Bochan; David Chansolme; Anurag Gandhi; Kathleen Sheridan; Ivan Soosaipillai; Thomas Walsh; Jill Massey

doi:10.1093/ofid/ofz479

The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections

Open Forum Infect Dis. 2019 Nov 4;6(11):ofz479. doi: 10.1093/ofid/ofz479. eCollection 2019 Nov.

Authors

Mark Redell¹, Miguel Sierra-Hoffman^{2

3}, Maha Assi⁴, Markian Bochan⁵, David Chansolme⁶, Anurag Gandhi⁷, Kathleen Sheridan⁸, Ivan Soosaipillai⁹, Thomas Walsh¹⁰, Jill Massey¹

Affiliations

¹ Melinta Therapeutics, Morristown, New Jersey, USA.
² Director of Research, Texas A&M affiliated Detar Family Medicine Program & College of Medicine, Victoria, Texas, USA.
³ Texas A&M University, Bryan, Texas, USA.
⁴ IDC Clinical Research, Wichita, Kansas, USA.
⁵ Infectious Diseases of Indiana, Indianapolis, Indiana, USA.
⁶ Infectious Disease Consultants of Oklahoma City, Oklahoma City, Oklahoma, USA.
⁷ Birmingham Infectious Disease and Infusion, Birmingham, Alabama, USA.
⁸ University of Pittsburgh Physicians, Pittsburgh, Pennsylvania, USA.
⁹ Infectious Disease Associates of North Central Florida, Ocala, Florida, USA.
¹⁰ Allegheny Health Network, Pittsburgh, Pennsylvania, USA.

Abstract

Background: Oritavancin (ORI) is a long-acting lipoglycopeptide indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible Gram-positive (GP) pathogens.

Methods: Data collected from a retrospective observational program (2014-2017), Clinical and Historic Registry and Orbactiv Medical Evaluation (CHROME), describe the utilization, outcomes, and adverse events (AEs) associated with ORI in 440 patients treated at 26 US sites for ABSSSI and other GP infections.

Results: Clinical success in evaluable patients receiving at least 1 dose of oritavancin was 88.1% (386/438). In a subgroup of patients who received ORI for skin and soft tissue infections (n = 401) and bacteremia (n = 7), clinical success was achieved in 89.0% and 100%, respectively. A cohort of 32 patients received 2-10 ORI doses separated by no more than 14 days for complicated GP infections. Clinical success was observed in 30 of 32 patients (93.8%), including 10 of 11 (90.9%) patients with bone and joint infections and 7 of 8 (87.5%) patients with osteomyelitis. In the safety evaluable population, the overall rate of AEs was 6.6%.

Conclusions: We describe results from a real-world program that includes the largest multicenter, retrospective, observational study in patients who received at least 1 dose of ORI for the treatment of GP infections. This study confirms that ORI is an effective, well-tolerated antibiotic used in single and multiple doses for the treatment of ABSSSIs and complicated GP infections.

Keywords: ABSSSI; oritavancin; real-world experience; registry; skin infections.