To study the efficacy and outcome of intravenous colistin therapy in culture positive multidrug resistant or extensively drug resistant sepsis in outborn neonates.A prospective observation study

SUMMARY

Sepsis is a systemic inflammatory response syndrome caused by infection and accompanied by pathological inflammation and organ system dysfunction. Neonatal sepsis continues to be a significant contributor to neonatal morbidity and mortality globally, particularly in low- and middle-income countries (LMICs) such as India The burden is even more pronounced in outborn neonates.

In India over two-thirds of isolates were gram-negative organisms. These organisms are now frequently multidrug-resistant (MDR) or extensively drug-resistant (XDR). The rise of MDR and extensively drug-resistant (XDR) strains has posed a formidable challenge to clinicians as infections caused by these pathogens are resistant to all commonly used antibiotics, leaving limited treatment options. In India, weak enforcement of regulations surrounding over-the-counter antibiotic sales, their affordability, and a surge in usage driven by economic growth and prosperity significantly contribute to the rise of antibiotics resistance The situation has led to the reconsideration of older antibiotics, including the polymyxins—primarily colistin (polymyxin E)—as agents of last resort.

In India, neonatal units, particularly in tertiary care referral hospitals have adopted colistin into their sepsis treatment algorithms. There is a lack of standardized clinical guidelines for administering intravenous colistin to neonates. Most existing recommendations are derived from adult studies, limited pediatrics research, and a few retrospective investigations involving neonates. Although colistin has shown efficacy in treating multidrug-resistant (MDR) Gram-negative bacterial infections in this population, the variability in treatment outcomes indicates the need for further research. Several factors can affect treatment success, including the timing of therapy initiation, dosage, in vivo bacterial susceptibility, concurrent use of other antibiotics with colistin, severity of sepsis, and the presence of comorbidities. To establish clearer efficacy and safety benchmarks and identify predictors of positive outcomes, prospective studies are essential. This study aims to provide evidence regarding the clinical outcomes, survival rates, and microbiological responses of colistin in outborn neonates (infants born outside a tertiary perinatal unit) centers. Proportion of neonates showing microbiological clearance with IV colistin therapy. This study is also directed to study about, Proportion of neonates having adverse effects like Acute Kidney Injury, electrolyte disturbances like hypokalaemia, hypomagnesemia. To compare the effect of colistin monotherapy versus colistin multidrug therapy showing. on microbiological cure. To compare the mortality and clinical outcomes of colistin monotherapy versus colistin multidrug therapy, To study the duration of Colistin therapy and its correlation with duration of hospital stay.