Cefixim versus amoxicillin-clavulanate in the treatment of acute exacerbation of chronic bronchitis, in patients with risk factors

This multicenter open, randomised trial had for aim to compare clinical efficacy and safety of Cefixim (CFM; 200 mg b.i.d. for 8 days) to these of Amoxicillin-clavulanate (ACA; 500 mg t.i.d. for 8 days) in the treatment of acute exacerbation of chronic bronchopathies in patients with risk factors. This trial was carried out by 70 general practitioners with 4 hospital pneumologists. 245 patients were enrolled in this trial, 120 treated with CFM and 125 treated with ACA. 151 sputum samples, responding to the Murray - Washington criteria were obtained at inclusion. 48/151 (32 %) samples were associated with an inoculum size of at least 10(7) CFU/ml. 42 strains considered as pathogenic were isolated: Haemophilus influenzae (24; 57 %), Streptococcus pneumoniae (12; 29 %), Moraxella sp (5; 12 %), Staphylococcus aureus (1, 2 %). The intent-to-treat analysis of the main assessment criteria (i.e. the clinical efficacy assessed at end of treatment) showed that the rates of successfull clinical outcomes were comparable for both groups, with 111/120 (93 %) success rate for CFM and 113/124 (91 %) for ACA (p = 0.69). A clinical relapse occured for 2/109 (2 %) patients treated with CFM and 4/111 (4 %) patients treated with ACA (p = 0.42). Retrocession of symptoms (dyspnea, sputum volume and appearance) was reported for 66/104 (64 %) patients treated with CFM and for 72/107 (67 %) patients treated with ACA. Average time for the occurrence of symptom retrocession was of 7 and 8 days for CFM and ACA respectively (Log rank, p = 0.95). 16/120 (13 %) patients in the CFM group and 29/124 (23 %) patients in the ACA group experienced at least one adverse event during the course of the trial (p = 0.04), Patients with at least one adverse event related to the treatment were 4/120 (3 %) in the CFM group and 16/124 (13 %) in the ACA group (p = 0.006). Treatment discontinuations for adverse event were noted for 2 and 5 patients in CFM and ACA groups respectively. Cefixime was demonstrated to be as effective and better tolerated than Amoxicillin-clavulanate, in the treatment of acute exacerbation of chronic bronchitis in patients with risk factors.