A Real-World Evidence Study to Evaluate the Clinical Effectiveness and Safety of Cefixime Suspension in Managing Paediatric Infections

Author(s): Dr. Binod Kumar Singh, Dr. Kamlesh Haria, Dr. Amitrajit Pal, Dr. Dattatray Pawar, Dr. Akhilesh Sharma

Background: Bacterial infections continue to be a significant source of morbidity and mortality in children, especially in developing countries. Cefixime, a third-generation cephalosporin, is a commonly used oral cephalosporin that has extensive activity with ease of administration.

Objective: To assess the real-world effectiveness and safety of cefixime for the treatment of bacterial infections in children in a variety of clinical centres in India.

Methods: This multicentre retrospective study assessed anonymised data from 6,768 paediatric patients (≤18 years) who were treated with cefixime 200 mg/5 mL oral suspension as a part of routine clinical practice. Clinical and microbiological effectiveness, vital signs, laboratory values, and adverse events were evaluated at baseline, end of treatment (7 days), and follow-up (14 days after treatment) based on the availability of medical information.

Results: Clinical cure was obtained at the end of therapy in 77.4% of patients, rising to 100% at follow-up. All patients were culture-positive at baseline; microbiological eradication reached 83.9% by EOT and 100% at follow-up. The most prevalent pathogen was Salmonella typhi (59.4%). Average treatment time was 7.7 days, with a mean duration of hospitalization of 1.32 days. Fewer than 0.05% of the patients had mild, transient side effects.

Conclusion: Cefixime has shown notable effectiveness in terms of rapid symptom resolution and a favourable safety profile in the treatment of pediatric bacterial infections. This evidence supports its continued use as a reliable therapeutic option, particularly in regions with a high prevalence of resistant bacterial strains, where standard first-line agents may be less effective.