Post-marketing Safety and Efficacy Evaluation of a Novel Drug CSE-1034: A Drug-use Analysis in Paediatric Patients with Hospital-acquired Pneumonia
Journal Title: Journal of Clinical and Diagnostic Research - Year 2018, Vol 12, Issue 9
Abstract
ABSTRACT 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.
Authors and Affiliations
Manu Chaudhary, Shiekh Gazalla Ayub, Mohd Amin Mir
Keywords
Related Articles
- EP ID EP523882
- DOI 10.7860/JCDR/2018/31549.12059
- Views 32
- Downloads 0
A Novel Technique to Overcome Treatment Delay Between Facemask Therapy and Comprehensive Orthodontic Correction
Images in Medicine
Pigmented Villonodular Synovitis of Thumb-A Cytological Diagnosis
Pigmented Villonodular Synovitis (PVNS) is a unique benign proliferative process of unknown aetiology involving the synovial lined joints diffusely or focally. The entity remains a diagnostic challenge. This condition is...
Disorders Affecting Quality of Life During Pregnancy: A Qualitative Study
Introduction: Pregnancy is a special condition which results in unique physiological responses which is more than any other physiological event and it increase stress in women’s body. Information about the changes experi...
A Prospective Analysis of Drug Interactions in Patients of Intensive Cardiac Care Unit
Introduction: Drug-Drug Interaction (DDI) is a serious concern in cardiac patients due to polypharmacy. Aim: The present study was aimed to identify the potential DDI among hospitalized cardiac patients and evaluate the...
Association of Metabolic Syndrome in Chronic Plaque Psoriasis Patients and their Correlation with Disease Severity, Duration and Age: A Case Control Study from Western Maharashtra
Introduction: Psoriasis is a chronic systemic inflammatory disease where the skin and the joints are the primary targets. Despite the fact that psoriasis carries minimal risk of mortality, it is associated with significa...