Comparison of sulbactam/ampicillin and cefuroxime in infections of the lower respiratory tract: results of a prospective, randomized and comparative study.

In a randomized, prospective study, ampicillin (AMP) in combination with the beta-lactamase-inhibitor sulbactam (SBT) was compared with cefuroxime (CXM) in 73 hospitalized patients with lower respiratory tract infections. Of these patients 36 received SBT/AMP 1 g/2 g tid and 37 received CXM 1.5 g tid - both in the form of intravenous infusion. The duration of treatment ranged from 5 to 12 days, with a median of 8 days in each group. In the SBT/AMP group, 23 patients (64%) had pneumonia, while 13 (36%) had acute purulent bronchitis; 13 of the patients (36%) received artificial respiration. In the CXM group, 23 patients (62%) had pneumonia and 14 (38%) acute purulent bronchitis; eight patients (22%) required artificial respiration. In 54 patients (SBT/AMP: 26; CXM: 28), initial culture yielded bacterial pathogens, mainly Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus and pneumococci. In each group, 35 patients were clinically evaluable. Of the patients receiving SBT/AMP, 31 (89%) responded to treatment and 28 patients (80%) responded to treatment with CXM. Four patients (11%) who received SBT/AMP failed to respond, as did seven patients on CXM. The bacteriological efficacy was assessed in 26 patients in the SBT/AMP group: in 22 cases (84%) baseline pathogens were eradicated, while in two patients (8%), there was persistent infection and a superinfection, respectively. In 23 patients (82%) of the CXM group (28 patients evaluated), the pathogens were eradicated, while three cases (11%) had persistent infection, and two (7%) superinfection. Apart from a case of exanthema under CXM, no adverse drug reactions were reported. No statistically significant differences were seen between the two groups. SBT/AMP proved to be a safe and effective alternative to CXM in the treatment of lower respiratory tract infections in hospitalized patients.

RCT Entities:   Population Interventions Outcomes