Efficacy Profile
Help take control with ZINPLAVA: Reduce CDI recurrence in high-risk adult patients receiving CDI antibiotics
Learn more about
In the same clinical trials...
Efficacy in patients at high risk for CDI recurrence was consistent with the overall trial population
Sustained clinical response absolute risk difference in prespecified patients at high risk for CDI recurrence1,2

- Overall, 76% (1,175 of 1,554) of study participants had one or more risk factors for recurrent CDI.
- 51% of the overall study population were ≥65 years of age (n=795).
- 28% had a history of CDI in the 6 months prior to treatment (≥1 episodes) (n=435).
- 21% were immunocompromised (n=331).
- 16% had severe CDI at day of infusion (n=247). Severe CDI was defined by a Zar score of ≥2.
- 22% had a hypervirulent strain, with 87% of those having C. difficile ribotype 027 (189 of 217 strains).
CDI recurrence absolute risk difference in prespecified high-risk patients1,2

The NNT* to prevent 1 episode of recurrent CDI among patients aged ≥ 65 was 5.5 for MODIFY I and 7.1 for MODIFY II.1
*NNT - Number needed to treat
Study design
Efficacy and safety of ZINPLAVA were investigated in 2 randomized, double-blind, placebo-controlled, multicenter Phase 3 trials in 1,554 adult patients. Enrolled patients had a confirmed diagnosis of CDI, defined as diarrhea (≥3 loose bowel movements in ≤24 hours) and a positive stool test for toxigenic C. difficile from a stool sample collected ≤7 days before study entry. Patients received a 10- to 14-day course of oral CDI antibiotics (metronidazole, vancomycin, or fidaxomicin). Patients were randomized to receive either a single 10-mg/kg (body weight) IV infusion of ZINPLAVA (n=781) or placebo IV (n=773) during the course of the CDI antibiotic therapy. Patients were assessed for clinical cure of the presenting CDI episode, defined as no diarrhea for 2 consecutive days following the completion of a ≤14-day CDI regimen. Patients who achieved clinical cure were then assessed for recurrence of CDI through 12 weeks following administration of the infusion of ZINPLAVA or placebo.
References
1. Wilcox MH, Gerding DN, Poxton IR, et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection. N Engl J Med. 2017;376:305-317. doi: 10.1056/NEJMoa1602615 Accessed May 28, 2020. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1602615/suppl_file/nejmoa1602615_appendix.pdf
2. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package US-MKB-00398.
Continue to read more about: