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Treatment of Clostridium difficile Infection With Tigecycline: Proof of Concept Study

Stein, Gary E. PharmD*; Smith, Curtis L. PharmD; Nicolau, David P. PharmD; Young, Vincent MD§; Citron, Diane M. BS; Scharmen, Amy BS*; Mitra, Subhashis MD*; Tran, Mary Ann MD*; Kalra, Apoorv MD*; Havlichek, Daniel H. MD*; Goldstein, Ellie J.C. MD

Infectious Diseases in Clinical Practice:
doi: 10.1097/IPC.0000000000000113
Original Articles
Abstract

Background: Cases of tigecycline treatment, as single or adjacent therapy, have been reported in patients with Clostridium difficile infection (CDI). At present, there have not been any controlled investigations of tigecycline in this patient population.

Methods: Ten hospitalized adult patients with CDI were treated with standard doses of intravenous tigecycline and oral vancomycin or metronidazole therapy. Susceptibility testing and polymerase chain reaction ribotyping of C difficile isolates were performed on initial fecal specimens. Blood and fecal concentrations of tigecycline were determined on day 3 of treatment by high-performance liquid chromatography. The efficacy and safety of treatment was assessed each day of hospitalization and for 30 days after discharge.

Results: The C difficile isolates cultured from these patients exhibited similar minimum inhibitory concentrations (range, 0.125–0.25 mg/L) to tigecycline irrespective of ribotype. The mean ± SD fecal concentration of tigecycline (17.8 ± 23.8 μg/g) on day 3 of treatment was almost 100 times higher than the corresponding mean ± SD serum level (0.18 ± 0.14 mg/L). No serious untoward events occurred during this study, but 2 patients had mild nausea associated with tigecycline administration. In general, these patients did well after hospital discharge, but one had recurrent CDI and was hospitalized during the follow-up period.

Conclusions: The results from this investigation support further study of intravenous tigecycline in patients with CDI.

Author Information

From the *Department of Medicine, Michigan State University, East Lansing, MI; †College of Pharmacy, Ferris State University, Lansing, MI; ‡Center for Anti-Infective Research, Hartford Hospital, Hartford, CT; §Department of Medicine, University of Michigan, Ann Arbor, MI; and ∥R.M. Alden Research Laboratory, Culver City, CA.

Correspondence to: Gary E. Stein, PharmD, Department of Medicine, Michigan State University, East Lansing, MI. E-mail: Gary.Stein@hc.msu.edu.

Gary E. Stein received a research grant from Pfizer, Inc. The remaining authors have no conflicts of interest to disclose.

This study was supported in part by a research grant from Pfizer, Inc.

© 2014 by Lippincott Williams & Wilkins.