PMID- 31844635 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220411 IS - 2328-8957 (Print) IS - 2328-8957 (Electronic) IS - 2328-8957 (Linking) VI - 6 IP - 11 DP - 2019 Nov TI - The CHROME Study, a Real-world Experience of Single- and Multiple-Dose Oritavancin for Treatment of Gram-Positive Infections. PG - ofz479 LID - 10.1093/ofid/ofz479 [doi] LID - ofz479 AB - 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. CI - (c) The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America. FAU - Redell, Mark AU - Redell M AD - Melinta Therapeutics, Morristown, New Jersey, USA. FAU - Sierra-Hoffman, Miguel AU - Sierra-Hoffman M AD - Director of Research, Texas A&M affiliated Detar Family Medicine Program & College of Medicine, Victoria, Texas, USA. AD - Texas A&M University, Bryan, Texas, USA. FAU - Assi, Maha AU - Assi M AD - IDC Clinical Research, Wichita, Kansas, USA. FAU - Bochan, Markian AU - Bochan M AD - Infectious Diseases of Indiana, Indianapolis, Indiana, USA. FAU - Chansolme, David AU - Chansolme D AD - Infectious Disease Consultants of Oklahoma City, Oklahoma City, Oklahoma, USA. FAU - Gandhi, Anurag AU - Gandhi A AD - Birmingham Infectious Disease and Infusion, Birmingham, Alabama, USA. FAU - Sheridan, Kathleen AU - Sheridan K AD - University of Pittsburgh Physicians, Pittsburgh, Pennsylvania, USA. FAU - Soosaipillai, Ivan AU - Soosaipillai I AD - Infectious Disease Associates of North Central Florida, Ocala, Florida, USA. FAU - Walsh, Thomas AU - Walsh T AD - Allegheny Health Network, Pittsburgh, Pennsylvania, USA. FAU - Massey, Jill AU - Massey J AD - Melinta Therapeutics, Morristown, New Jersey, USA. LA - eng PT - Journal Article DEP - 20191104 PL - United States TA - Open Forum Infect Dis JT - Open forum infectious diseases JID - 101637045 PMC - PMC6903788 OTO - NOTNLM OT - ABSSSI OT - oritavancin OT - real-world experience OT - registry OT - skin infections EDAT- 2019/12/18 06:00 MHDA- 2019/12/18 06:01 PMCR- 2019/11/04 CRDT- 2019/12/18 06:00 PHST- 2019/08/15 00:00 [received] PHST- 2019/11/01 00:00 [accepted] PHST- 2019/12/18 06:00 [entrez] PHST- 2019/12/18 06:00 [pubmed] PHST- 2019/12/18 06:01 [medline] PHST- 2019/11/04 00:00 [pmc-release] AID - ofz479 [pii] AID - 10.1093/ofid/ofz479 [doi] PST - epublish SO - Open Forum Infect Dis. 2019 Nov 4;6(11):ofz479. doi: 10.1093/ofid/ofz479. eCollection 2019 Nov.