Universität zu Köln

Basu, Anirban, Prabhu, Vimalanand S., Dorr, Mary Beth, Golan, Yoav, Dubberke, Erik R., Cornely, Oliver A., Heimann, Sebastian M., Pedley, Alison, Xu, Ruifeng, Hanson, Mary E. and Marcella, Stephen (2018). Bezlotoxumab Is Associated With a Reduction in Cumulative Inpatient-Days: Analysis of the Hospitalization Data From the MODIFY I and II Clinical Trials. Open Forum Infect. Dis., 5 (11). CARY: OXFORD UNIV PRESS INC. ISSN 2328-8957

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Abstract

Background. Patients with recurrent Clostridium difficile infection (rCDI) are more likely to have a hospital readmission and spend increased time in inpatient settings compared with patients with primary CDI. MODIFY I and II demonstrated that bezlotoxumab significantly reduced rCDI vs placebo. A post hoc within-trial analysis assessed whether bezlotoxumab was associated with a reduction in cumulative inpatient-days. Methods. Data were pooled from the MODIFY trials to estimate the cumulative hospitalized days summed over the 84-day follow-up period. We adjusted inpatient use data from pooled MODIFY I and II for survival and censoring to estimate 84-day cumulative inpatient-days, overall and for subgroups. Treatment effects were obtained using recycled predictions based on trial protocol and rCDI risk, and 95% confidence intervals were obtained using 1000 bootstrap replicates. Results. Mean cumulative inpatient-days were greater in the placebo arm (14.1 days) vs the bezlotoxumab arm (12.1 days) in the overall population. The mean difference between treatment groups was 2.1 days (95% confidence interval, -0.4 to -3.7). This was consistent in participants with risk factors for rCDI: age >= 65 years, compromised immunity, severe CDI, prior CDI, and ribo-type 027/078/244 infection. As the number of risk factors increased, bezlotoxumab resulted in greater reductions in the number of inpatient-days compared with placebo (difference: -1.2 days, -2.3 days, -2.5 days, and -3.0 days for 0, 1, 2, and >= 3 risk factors, respectively). Conclusions. Bezlotoxumab was associated with a reduction in cumulative inpatient-days, suggesting that treatment with bezlotoxumab may substantially reduce rCDI-associated health care resource use.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Basu, Anirban UNSPECIFIED UNSPECIFIED UNSPECIFIED Prabhu, Vimalanand S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Dorr, Mary Beth UNSPECIFIED UNSPECIFIED UNSPECIFIED Golan, Yoav UNSPECIFIED UNSPECIFIED UNSPECIFIED Dubberke, Erik R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Cornely, Oliver A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Heimann, Sebastian M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pedley, Alison UNSPECIFIED UNSPECIFIED UNSPECIFIED Xu, Ruifeng UNSPECIFIED UNSPECIFIED UNSPECIFIED Hanson, Mary E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Marcella, Stephen UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-166301
DOI:	10.1093/ofid/ofy218
Journal or Publication Title:	Open Forum Infect. Dis.
Volume:	5
Number:	11
Date:	2018
Publisher:	OXFORD UNIV PRESS INC
Place of Publication:	CARY
ISSN:	2328-8957
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CLOSTRIDIUM-DIFFICILE INFECTION; ECONOMIC BURDEN; VANCOMYCIN; METRONIDAZOLE; READMISSIONS; PREVENTION; MORTALITY; DIARRHEA; IMPACT; RISK Multiple languages Immunology; Infectious Diseases; Microbiology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/16630