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

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

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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.

Copyright © 2013 by Lippincott Williams & Wilkins

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