PMID- 34160474 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220424 IS - 2328-8957 (Print) IS - 2328-8957 (Electronic) IS - 2328-8957 (Linking) VI - 8 IP - 6 DP - 2021 Jun TI - Efficacy of Omadacycline Versus Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia by Disease Severity: Results From the OPTIC Study. PG - ofab135 LID - 10.1093/ofid/ofab135 [doi] LID - ofab135 AB - BACKGROUND: Severity/mortality risk scores and disease characteristics may assist in deciding whether patients with community-acquired bacterial pneumonia (CABP) require outpatient treatment or hospitalization. The phase 3 OPTIC (Omadacycline for Pneumonia Treatment In the Community) study enrolled patients with Pneumonia Outcomes Research Team (PORT) risk class II-IV. Omadacycline demonstrated noninferiority to moxifloxacin in adults with CABP, at early clinical response (ECR) and posttreatment evaluation (PTE). We assessed efficacy of omadacycline versus moxifloxacin in these patients based on disease severity. METHODS: Patients were randomized 1:1 to receive intravenous (IV) omadacycline (100 mg every 12 hours for 2 doses followed by 100 mg daily [q24h], with optional transition to omadacycline 300 mg orally q24h after 3 days of IV treatment) or moxifloxacin IV 400 mg q24h (with optional transition to 400 mg orally q24h after 3 days of IV treatment). Total treatment duration was 7-14 days. We compared rates of early clinical success (72-120 hours after first dose) and investigator-assessed clinical success at PTE (5-10 days after last dose) in subgroups based (1) on severity/mortality risk scores (PORT, CURB-65, systemic inflammatory response syndrome, quick Sequential [Sepsis-related] Organ Failure Assessment, modified ATS, SMART-COP) and (2) on presence of baseline radiographic characteristics, chronic obstructive pulmonary disease (COPD)/asthma, or bacteremia. RESULTS: Altogether, 774 patients (omadacycline, n = 386; moxifloxacin, n = 388) were randomized. Clinical success rates (ECR/PTE) were similar between treatment groups (across all subgroups). Efficacy across treatment groups was similar in patients with baseline radiographic characteristics or COPD/asthma, but moxifloxacin had higher clinical success rates in patients with bacteremia. CONCLUSIONS: Efficacy of omadacycline was similar to that of moxifloxacin, regardless of disease severity/mortality risk and disease characteristics. CI - (c) The Author(s) 2021. Published by Oxford University Press on behalf of Infectious Diseases Society of America. FAU - Ramirez, Julio AU - Ramirez J AD - Division of Infectious Diseases, Department of Medicine, University of Louisville, Louisville, Kentucky, USA. FAU - Deck, Daniel H AU - Deck DH AD - Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA. FAU - Eckburg, Paul B AU - Eckburg PB AD - Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA. FAU - Curran, Marla AU - Curran M AD - Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA. FAU - Das, Anita F AU - Das AF AD - AD Stats Consulting, Guerneville, California, USA. FAU - Kirsch, Courtney AU - Kirsch C AD - Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA. FAU - Manley, Amy AU - Manley A AD - Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA. FAU - Tzanis, Evan AU - Tzanis E AD - Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA. FAU - McGovern, Paul C AU - McGovern PC AD - Paratek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA. LA - eng PT - Comment PT - Journal Article DEP - 20210618 PL - United States TA - Open Forum Infect Dis JT - Open forum infectious diseases JID - 101637045 CON - Open Forum Infect Dis. 2021 Jun 18;8(6):ofab136. PMID: 34160473 PMC - PMC8212944 OTO - NOTNLM OT - community-acquired bacterial pneumonia OT - moxifloxacin OT - omadacycline OT - severity EDAT- 2021/06/24 06:00 MHDA- 2021/06/24 06:01 PMCR- 2021/06/18 CRDT- 2021/06/23 12:20 PHST- 2020/09/10 00:00 [received] PHST- 2021/03/25 00:00 [accepted] PHST- 2021/06/23 12:20 [entrez] PHST- 2021/06/24 06:00 [pubmed] PHST- 2021/06/24 06:01 [medline] PHST- 2021/06/18 00:00 [pmc-release] AID - ofab135 [pii] AID - 10.1093/ofid/ofab135 [doi] PST - epublish SO - Open Forum Infect Dis. 2021 Jun 18;8(6):ofab135. doi: 10.1093/ofid/ofab135. eCollection 2021 Jun.