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 clinica l efficacy and safety of Cefixim (CFM; 200 mg b.i.d. for 8 days) to th ese 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 practition ers with 4 hospital pneumologists. 245 patients were enrolled in this trial, 120 treated with CFM and 125 treated with ACA. 151 sputum sampl es, responding to the Murray - Washington criteria were obtained at in clusion. 48/151 (32 %) samples were associated with an inoculum size o f at least 10(7) CFU/ml. 42 strains considered as pathogenic were isol ated: Haemophilus influenzae (24; 57 %), Streptococcus pneumoniae (12; 29 %), Moraxella sp (5; 12 %), Staphylococcus aureus (1, 2 %). The in tent-to-treat analysis of the main assessment criteria (i.e. the clini cal efficacy assessed at end of treatment) showed that the rates of su ccessfull 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 66/1 04 (64 %) patients treated with CFM and for 72/107 (67 %) patients tre ated 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 i n the ACA group experienced at least one adverse event during the cour se of the trial (p = 0.04), Patients with at least one adverse event r elated 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 adv erse event were noted for 2 and 5 patients in CFM and ACA groups respe ctively. Cefixime was demonstrated to be as effective and better toler ated than Amoxicillin-clavulanate, in the treatment of acute exacerbat ion of chronic bronchitis in patients with risk factors.