EFFICACY AND SAFETY OF LEFAMULIN VS MOXIFLOXACIN FOR ATYPICAL RESPIRATORY PATHOGENS IN ADULTS WITH COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA: POOLED RESULTS FROM THE LEFAMULIN EVALUATION AGAINST PNEUMONIA (LEAP) 1 AND LEAP 2 DOUBLE-BLIND NONINFERIORITY PHASE-3 CLINICAL TRIALS

Abstract Background The objective of this analysis was to evaluate the efficacy and safety of oritavancin compared with vancomycin for patients with acute bacterial skin and skin structure infections (ABSSSIs) who received treatment in the outpatient setting in the Phase 3 SOLO clinical trials. Methods SOLO I and SOLO II were 2 identically designed comparative, multicenter, double-blind, randomized studies to evaluate the efficacy and safety of a single 1200-mg dose of intravenous (IV) oritavancin versus 7–10 days of twice-daily IV vancomycin for the treatment of ABSSSI. Protocols were amended to allow enrolled patients to complete their entire course of antimicrobial therapy in an outpatient setting. The primary efficacy outcome was a composite endpoint (cessation of spread or reduction in size of the baseline lesion, absence of fever, and no rescue antibiotic at early clinical evaluation [ECE]) (48 to 72 hours). Key secondary endpoints included investigator-assessed clinical cure 7 to 14 days after end of treatment (posttherapy evaluation [PTE]) and 20% or greater reduction in lesion area at ECE. Safety was assessed until day 60. Results Seven hundred ninety-two patients (oritavancin, 392; vancomycin, 400) received entire course of treatment in the outpatient setting. Efficacy response rates at ECE and PTE were similar (primary composite endpoint at ECE: 80.4% vs 77.5% for oritavancin and vancomycin, respectively) as was incidence of adverse events. Five patients (1.3%) who received oritavancin and 9 (2.3%) vancomycin patients were subsequently admitted to a hospital. Conclusions Oritavancin provides a single-dose alternative to multidose vancomycin for treatment of ABSSSI in the outpatient setting.

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SAFETY AND TOLERABILITY OF LEFAMULIN VS MOXIFLOXACIN IN ADULTS WITH COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA: RESULTS OF THE LEFAMULIN EVALUATION AGAINST PNEUMONIA (LEAP) 1 AND LEAP 2 DOUBLE-BLIND NONINFERIORITY PHASE-3 CLINICAL TRIALS

CHEST Journal ◽

10.1016/j.chest.2019.08.1030 ◽

2019 ◽

Vol 156 (4) ◽

pp. A1127-A1128

Author(s):

Christian Sandrock ◽

Jennifer Schranz ◽

Lisa Goldberg ◽

Elizabeth Alexander ◽

Gregory Moran ◽

...

Keyword(s):

Clinical Trials ◽

Bacterial Pneumonia ◽

Phase 3 ◽

Double Blind

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929d Eluxadoline for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: Results of 2 Randomized, Double-blind, Placebo-Controlled Phase 3 Clinical Trials of Efficacy and Safety

Gastroenterology ◽

10.1016/s0016-5085(14)60568-0 ◽

2014 ◽

Vol 146 (5) ◽

pp. S-159 ◽

Cited By ~ 5

Author(s):

Anthony Lembo ◽

Scott Dove ◽

David Andrae ◽

J. Michael Davenport ◽

Gail McIntyre ◽

...

Keyword(s):

Clinical Trials ◽

Irritable Bowel Syndrome ◽

Efficacy And Safety ◽

Phase 3 ◽

Double Blind ◽

Double Blind Placebo ◽

Irritable Bowel

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A Phase-3 Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults with Community-acquired Bacterial Pneumonia (DEFINE-CABP)

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz514 ◽

2019 ◽

Cited By ~ 2

Author(s):

Juan P Horcajada ◽

Robert A Salata ◽

Rodolfo Álvarez-Sala ◽

Floarea Mimi Nitu ◽

Laura Lawrence ◽

...

Keyword(s):

Clinical Response ◽

Bacterial Pneumonia ◽

Study Drug ◽

The United States ◽

Efficacy And Safety ◽

Success Rates ◽

Phase 3 ◽

Double Blind ◽

Atypical Pathogens ◽

Intent To Treat

Abstract Background The clinical and economic burden of community-acquired bacterial pneumonia (CABP) is significant and is anticipated to increase as the population ages and pathogens become more resistant. Delafloxacin is a fluoroquinolone antibiotic approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections. Delafloxacin’s shape and charge profile uniquely impacts its spectrum of activity and side effect profile. This phase 3 study compared the efficacy and safety of delafloxacin to moxifloxacin for the treatment of CABP. Methods A randomized, double-blind, comparator-controlled, multicenter, global Phase 3 study compared the efficacy and safety of delafloxacin 300 mg BID or moxifloxacin 400 mg QD in adults with CABP. The primary endpoint was early clinical response (ECR) defined as improvement at 96 (± 24) hours after first dose of study drug. Clinical response at test of cure (TOC) and microbiologic response were also assessed. Results In the intent-to-treat analysis population (ITT), ECR rates were 88.9% in the delafloxacin group and 89.0% in the moxifloxacin group. Noninferiority of delafloxacin compared with moxifloxacin was demonstrated. At TOC in the ITT population, the success rates were similar between groups. Treatment-emergent adverse events considered at least possibly related to the study drug occurred in 65 subjects (15.2%) in the delafloxacin group and 54 (12.6%) in the moxifloxacin group. Conclusions IV/oral delafloxacin monotherapy is effective and well tolerated in the treatment of adults with CABP, providing coverage for grampositive, gramnegative, and atypical pathogens.

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