Cefditoren versus levofloxacin in patients with exacerbations of chronic bronchitis: serum inflammatory biomarkers, clinical efficacy, and microbiological eradication

Background: The aim of this open-label, randomized, parallel-group pilot study was to evaluate the efficacy of cefditoren pivoxil and levofloxacin in terms of speed of reduction in inflammatory parameters, clinical recovery, and microbiological eradication. Methods: Forty eligible patients with acute exacerbation of chronic bronchitis (AECB) were randomized to receive cefditoren 200 mg twice a day for 5 days (n = 20) or levofloxacin 500 mg once daily for 7 days (n = 20). Results: The inflammatory parameters which were significantly reduced at test-of-cure with respect to visit 1 were Krebs von den Lundgen-6 (KL-6) and interleukin-6. KL-6 decreased both in the overall study population (from 19 +/- 11 UI/mL to 6 +/- 8 UI/mL, P = 0.000) and in the cefditoren (from 19 +/- 13 UI/mL to 8 +/- 10 UI/mL, P = 0.006) and levofloxacin (from 19 +/- 10 UI/mL to 5 +/- 5 UI/mL, P = 0.000) arms. Similarly, interleukin-6 decreased both in the overall study population (from 13.35 +/- 16.41 pg/mL to 3 +/- 4.7 pg/mL, P = 0.000) and in the cefditoren (from 15.90 +/- 19.54 pg/mL to 4.13 +/- 6.42 pg/mL, P = 0.015) and levofloxacin (from 10.80 +/- 12.55 pg/mL to 1.87 +/- 1.16 pg/mL, P = 0.003) arms. At the end of treatment (test-of-cure, 6-9 days after drug initiation), the clinical success rate in the overall study population was 78%; the clinical cure rate was 80% in the cefditoren arm and 75% in the levofloxacin arm. Globally, bacteriological eradication at test-of-cure was obtained in 85% of the overall study population. Both treatments were well tolerated. Conclusion: Cefditoren represents a valid option in the treatment of mild to moderately severe cases of AECB in the outpatient care setting. Moreover, the use of this cephalosporin is associated with a significant reduction of interleukin-6 and KL-6, two key mediators of lung inflammation and epithelial damage.