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High-Dose Levofloxacin in Community-Acquired Pneumonia

A Randomized, Open-Label Study

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Abstract

Background: The conventional treatment for community-acquired pneumonia (CAP) involves combination therapy consisting of a β-lactam penicillin or a cephalosporin with a macrolide. Alternatively, high-dose levofloxacin treatment has been used as single-agent therapy for treating CAP, covering atypical pathogens.

Objective: This study compared the clinical efficacy and safety of high-dose levofloxacin with combined ceftriaxone and azithromycin for the treatment of CAP.

Patients and Methods: This phase IV, prospective, randomized, open-label trial enrolled patients admitted to a tertiary referral hospital for CAP treatment from 2010 to 2011. Hospital admission was decided based on clinical judgement and the pneumonia severity index. Forty subjects were enrolled and assigned to two treatment arms using a random numbers table. The 20 subjects in the experimental group were given levofloxacin 750 mg intravenously once daily, followed by the same dose of oral levofloxacin at discharge when clinically improved and the 20 subjects in the control group were given ceftriaxone 2.0 g intravenously once daily plus oral azithromycin 500 mg for 3 consecutive days, followed by oral cefpodoxime 200 mg per day at discharge after clinical improvement. The primary outcome was the clinical success rate. Secondary outcomes were the microbiological success rate and adverse events during the study.

Results: Of the 40 subjects enrolled, 36 completed the study: 17 in the experimental group and 19 in the control group. The groups did not differ in terms of demographic factors or clinical findings at baseline. The clinical success rate (cured + improved) was 94% in the experimental (levofloxacin) group and 84% in the control group (p>0.05). The microbiological success rate and overall adverse events were also similar in both groups.

Conclusion: Single-agent, high-dose levofloxacin treatment exhibited excellent clinical and microbiological efficacy with a safety profile comparable to that of ceftriaxone plus azithromycin therapy. Large-scale clinical trials are required to verify these results.

Clinical Trial Registration: WHO International Clinical Trials Registry: KCT0000374; Daiichi-Sankyo Korea study code: T11-13-V1.

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Acknowledgements

This study was funded from Daiichi-Sankyo Korea Ltd and approved by the Institutional Review Board of Mokdong Hospital (222-1-46), Ewha Womans University, Seoul, Korea. The role of the funding company was limited to the study design. The funding company was not involved in conducting the study, the data analysis, data interpretation or manuscript preparation.

The role of the corresponding author was the study design; conducting the study; collection, management, analysis and interpretation of the data; and preparation of the manuscript.

None of the authors have any relevant conflicts of interest.

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Authors and Affiliations

  1. Respiratory Center, Department of Internal Medicine, School of Medicine, Ewha Womans University, 911-1 Mok-5-dong, Yangcheon-gu, Seoul, 158-710, Korea

    Jin Hwa Lee, Seo Woo Kim, Ji Hye Kim, Yon Ju Ryu &  Jung Hyun Chang MD, PhD (Professor and Chief)

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  1. Jin Hwa Lee
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  2. Seo Woo Kim
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  3. Ji Hye Kim
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Correspondence to Jung Hyun Chang MD, PhD.

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Lee, J.H., Kim, S.W., Kim, J.H. et al. High-Dose Levofloxacin in Community-Acquired Pneumonia. Clin Drug Investig 32, 569–576 (2012). https://doi.org/10.1007/BF03261911

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