Post-marketing Safety and Efficacy Evaluation of a Novel Drug CSE-1034: A Drug-use Analysis in Paediatric Patients with Hospital-acquired Pneumonia OC25-OC28
Dr. Mohd Amin Mir,
Head Clinical Research, Venus Medicine Research Centre, Venus Remedies Ltd, Panchkula-134113, Haryana, India.
Introduction: Hospital-Acquired Pneumonia (HAP) is one of the common and frequently reported nosocomial infections with potential life-threatening complications in paediatric group. One of the drugs approved for treatment of various bacterial infections in all age groups is CSE-1034 (Ceftriaxone+Sulbactam+Disodiumedetate).
Aim: To investigate the efficacy of CSE-1034 in paediatric HAP patients and identify the associated adverse events in real clinical settings.
Materials and Methods: This Post-Marketing Surveillance (PMS) study on CSE-1034 was carried out on 450 paediatric HAP patients across 17 centres in India. Based on age, the patients were divided into three groups including infants, children and adolescents. The following information was recorded- demographic, clinical and microbiological parameters, dosage and treatment duration, concomitant medications and evaluation outcome events of treatment in terms of efficacy and Adverse Events (AEs). The statistical analysis was performed using chi-square test. The p-values were two-tailed and a value of <0.05 was considered statistically significant.
Results: In terms of drug efficacy, 400 patients were cured, 27 showed clinical improvement and 23 were reported as clinical failure. The mean treatment duration varied from 5-7 days. The total number of AEs reported was 55. The common AEs included pain at injection site (3.6%), fever (2.7%), vomiting (2.2%), nausea (1.8%), thromophlebitis (1%), itching (0.4%) and localised pain (0.4%). About 17 AEs were reported in infant group, 18 in children and 20 AEs were reported in adolescent group.
Conclusion: From this PMS study, it can be concluded that CSE-1034 is an effective option for the management of paediatric patients with HAP under routine clinical settings.