High-dose levofloxacin in community-acquired pneumonia: a randomized, open-label study
Jin Hwa Lee1, Seo Woo Kim, Ji Hye Kim
1Department of Internal Medicine, School of Medicine, Ewha Womans University, Seoul, Korea.
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.
Insights
High-dose levofloxacin demonstrated comparable clinical and microbiological efficacy to combination therapy for community-acquired pneumonia (CAP). This single-agent approach offers a safe and effective alternative for CAP treatment.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Medicine
Background:
- Community-acquired pneumonia (CAP) conventionally treated with combination therapy (β-lactam/macrolide).
- High-dose levofloxacin serves as an alternative single-agent therapy for CAP, effective against atypical pathogens.
Purpose of the Study:
- To compare the clinical efficacy and safety of high-dose levofloxacin versus combination therapy (ceftriaxone and azithromycin) for CAP treatment.
Main Methods:
- Phase IV, prospective, randomized, open-label trial with 40 CAP patients.
- Experimental group: Levofloxacin 750 mg IV daily.
- Control group: Ceftriaxone 2.0 g IV daily + Azithromycin 500 mg PO for 3 days.
Main Results:
- Clinical success rate was 94% for levofloxacin vs. 84% for combination therapy (p > 0.05).
- Microbiological success and adverse events were similar between groups.
- 36 of 40 enrolled patients completed the study.
Conclusions:
- Single-agent, high-dose levofloxacin shows excellent efficacy and comparable safety to ceftriaxone plus azithromycin for CAP.
- Further large-scale trials are needed to confirm these findings.
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