Article Text

EVALUATION OF EFFICACY AND SAFETY OF CEFOTAXIME SODIUM AND SULBACTAM IN CHILDREN WITH LOWER RESPIRATORY TRACT INFECTIONS
  1. A Pareek1,
  2. M V Kulkarni2,
  3. A S Deshpande3,
  4. S C Daga3,
  5. N B Chandurkar1,
  6. S R Kulkarni1,
  7. S P Dixit1
  1. 1Medical Affairs and Clinical Research Department, Ipca Laboratories Limited, Mumbai, India
  2. 2LTMM College and LTMG Hospital, Mumbai, India
  3. 3BJ Medical College and Sassoon General Hospital, Pune, India

Abstract

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.

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