Antimicrobial Stewardship Program in a Low-Middle Income Country: Impact of an Antibiotic Guideline for Neonatal...

Background/Objectives: Initiation of empiric antibiotic therapy for neonatal early-onset sepsis (EOS) is prudent to prevent morbidity and mortality, particularly in low- and middle-income countries (LMICs). Inappropriate or prolonged antibiotic exposure in neonates is associated with poor clinical outcomes. Antimicrobial stewardship programs (ASPs) have been shown to optimize antibiotic use, but data from LMICs are limited. In this study, we aimed to evaluate adherence to a locally developed and adopted guideline for antibiotic use in EOS. Methods: We conducted a retrospective before-and-after study during the pre- (June 2024-January 2025) and post-implementation (May-December 2025) of ASP guideline for EOS. The intervention involved consolidating best practices-previously shared verbally and applied variably into a locally united written guideline, then provide training to neonatologists, pharmacists, and nurses. Adherence to best practices was evaluated by indication, dosing, timing, and duration of antibiotic therapy. Results: In a cohort of 388 neonates with EOS (i.e., 205 pre- and 183 post-implementation), the median gestational age was 38 (IQR: [37-39]) weeks, with the median birthweight of 3000 (IQR: [2800-3400]) grams, and 63% were male. The total adherence improved from 2.0% to 65.6% (p < 0.001) from pre- to post-implementation of ASP. In the post period, adherence rates were 96.7% for empiric antibiotics indication, 95.6% for antibiotics indication after culture results are obtained, 88.5% for antibiotic dosing, 83.1% for timely antibiotic initiation, and 89.1% for appropriate discontinuation of antibiotics. The median days of therapy and length of therapy significantly decreased by 139 per 1000 patient-days, from 1806 (IQR: [1556-2083] to 1667 (IQR: [1400-2000]; p < 0.001)] patient-days; and from 1000 (IQR: [875-1000]) to 875 (IQR: [769-1000]; p < 0.001) patient-days in the pre- versus the post-implementation, respectively. Median length of hospitalization of 8 [7-12] days and recovery (~93%) from EOS were similar pre- and post-implementation. Conclusions: The results support the effectiveness of ASP implementation in improving guideline adherence and reducing antibiotic exposure among neonates with EOS in low-resource settings. In-hospital clinical outcomes, including mortality at discharge, were similar between periods; however, further studies with longer follow-up are needed to better evaluate clinical outcomes.