Objective Acute lower respiratory tract infections (LRTI) are the major cause of morbidity and mortality in children worldwide. Common pathogens involved in LRTI produce extended spectrum β-lactamases that can hydrolyze even higher generation cephalosporins that were initially designed to escape enzymatic degradation. A combination of cefotaxime and sulbactam (β-lactamase inhibitor) may be effective in combating resistance due to β-lactamase producing common respiratory pathogens.

The objective of the study was to evaluate comparative efficacy and safety of cefotaxime-sulbactam injection with amoxicillin-clavulanic acid injection in pediatric patients with LRTI.

Methods This multicentric, randomized, comparative study enrolled 102 pediatric in-patients diagnosed of pneumonia or bronchopneumonia. Patients received either cefotaxime-sulbactam (A) or amoxicillin-clavulanic acid (B) injection for up to 7 days.

Results The two treatment groups were comparable with respect to demography and disease characteristics at baseline (p<0.05). Efficacy was evaluated in 96 patients (A: 47/50; B: 49/52). Clinical success rate was 93.6% and 89.8%, respectively for group A and group B. Although not significant, more patients were symptom free in group A compared to group B (93.6% vs. 87.75%, respectively). Both the study medications were safe and well tolerated in the study population, except for a convulsion reported in one patient in group A.

Conclusion The cefotaxime-sulbactam combination was found to be as effective as widely prescribed co-amoxiclav therapy in the treatment of mild to moderate LRTI. This could provide an alternative therapeutic option to pediatricians for combating specific resistance due to β-lactamase producing common respiratory pathogens.