15 research outputs found
Moving “The Greatest Show On Earth”: W.C. Coup As An Innovation Champion
Purpose: This research aims to provide a historical example of how an innovation champion radically changed the operations of the circus industry by incorporating both the rational and actuation models in his scaling-up innovations. The innovations to the logistics and operations of the P. T. Barnum Circus, “The Greatest Show on Earth”, created by William C. Coup in response to the massive technological development of integrated railroad systems offer new insights into how management effectuation operates through the capabilities and experiences of an innovation champion. Design/methodology/approach: The authors use a theoretically anchored longitudinal study that captures the mechanisms and processes of innovation by adopting an explorative, inductive research design in the form of a single in-depth case analysis. Findings: Coup’s contributions show how the management innovation process works and adds detail with regard to how a champion of change may succeed in an effectuation process. Coup’s management innovation was in scaling-up others’ innovations. In an effectuation process similar to what entrepreneurs must do when their new ideas find a growing market acceptance, Coup repeatedly scaled-up others’ ideas in ways that changed how his industry operated. Originality/value: Although there is some agreement on how management influences innovation in their organizations, research identifying the characteristics of managers that cause them to be innovation champions is still evolving and this current work adds to this endeavor. This work provides a rich illustration of an innovation champion’s use of effectuation as a process of experimentation to discover pragmatic and effective solutions to problems arising from the use of new technology or scaling business models to levels never before imagined
Durable reduction of Clostridioides difficile infection recurrence and microbiome restoration after treatment with RBX2660: results from an open-label phase 2 clinical trial
Background
Effective treatment options for recurrent Clostridioides difficile infection (rCDI) are limited, with high recurrence rates associated with the current standard of care. Herein we report results from an open-label Phase 2 trial to evaluate the safety, efficacy, and durability of RBX2660—a standardized microbiota-based investigational live biotherapeutic—and a closely-matched historical control cohort.
Methods
This prospective, multicenter, open-label Phase 2 study enrolled patients who had experienced either ≥ 2 recurrences of CDI, treated by standard-of-care antibiotic therapy, after a primary CDI episode, or ≥ 2 episodes of severe CDI requiring hospitalization. Participants received up to 2 doses of RBX2660 rectally administered with doses 7 days apart. Treatment success was defined as the absence of CDI diarrhea without the need for retreatment for 8 weeks after completing study treatment. A historical control group with matched inclusion and exclusion criteria was identified from a retrospective chart review of participants treated with standard-of-care antibiotics for recurrent CDI who matched key criteria for the study. The primary objective was to compare treatment success of RBX2660 to the historical control group. A key secondary outcome was the safety profile of RBX2660, including adverse events and CDI occurrence through 24 months after treatment. In addition, fecal samples from RBX2660-treated participants were sequenced to evaluate microbiome composition and functional changes from before to after treatment.
Results
In this Phase 2 open-label clinical trial, RBX2660 demonstrated a 78.9% (112/142) treatment success rate compared to a 30.7% (23/75) for the historical control group (p < 0.0001; Chi-square test). Post-hoc analysis indicated that 91% (88/97) of evaluable RBX2660 responders remained CDI occurrence-free to 24 months after treatment demonstrating durability. RBX2660 was well-tolerated with mostly mild to moderate adverse events. The composition and diversity of RBX2660 responders’ fecal microbiome significantly changed from before to after treatment to become more similar to RBX2660, and these changes were durable to 24 months after treatment.
Conclusions
In this Phase 2 trial, RBX2660 was safe and effective for reducing rCDI recurrence as compared to a historical control group. Microbiome changes are consistent with restorative changes implicated in resisting C. difficile recurrence.
Clinical Trials Registration NCT02589847 (10/28/2015)Medicine, Faculty ofNon UBCPathology and Laboratory Medicine, Department ofReviewedFacultyResearche