Randomized, Multicentre, Comparative Clinical Evaluation of Cefuroxime–Sulbactam versus Amoxicillin–Clavulanic Acid Therapy in the Treatment of Lower Respiratory Tract Infections

Abstract

Thisrandomized, multicentre, comparative study evaluated the efficacy and safety of treatment with cefuroximesulbactam compared with amoxicillinclavulanic acid (co-amoxiclav) in patients with lower respiratory tract infections (LRTIs). The study enrolled 75 adult inpatients with moderate to severe LRTIs. Patients were treated intravenously for 7 -10 days. The treatment groups were comparable at baseline with respect to demographic and disease characteristics. Efficacy was evaluated in 72 patients. The clinical success rate was statistically superior in patients treated with cefuroxime-sulbactam (100%) compared with patients treated with amoxicillin-clavulanic acid (88%). The bacteriological success rate was 95% and 100% for cefuroxime-sulbactam and amoxicillin-clavulanic acid, respectively, with no significant difference between treatments. Both treatments were safe and well tolerated. One patient in the cefuroxime-sulbactam group reported convulsions, which the investigator considered were probably not related to the study medication. Cefuroximesulbactam can be an effective alternative empirical treatment for LRTIs.

Patients included in randomised controlled trials do not represent those seen in clinical practice: focus on antimicrobial agents

“…Their characteristics are summarised in Table 1. Seventeen (56.7%) of the RCTs referred to respiratory tract infections [8,10,12,15,16,19,21,[24][25][26]28,29,31,32,[35][36][37], five (16.7%) to skin and soft-tissue infections [9,11,14,22,27], four (13.3%) to intra-abdominal infections [17,23,30,33], two (6.7%) to gynaecological infections [18,34] and two (6.7%) to bloodstream infections [13,20].…”