Abstract
Objectives
To compare the efficacy of 10 d versus 14 d of antibiotic therapy in neonates with culture-positive sepsis.
Methods
Neonates with culture-positive sepsis were randomized to either 10-d or 14-d antibiotic therapy. These neonates were followed up to 28 d after discharge for treatment failure. Primary outcome of the study was treatment failure which was defined as readmission to the NICU within 4 wk of discharge with blood culture growing same organism with similar antibiogram or any readmission with signs of sepsis with negative blood culture.
Results
A total of 70 neonates were randomized to receive either 10 d (n = 35) or 14 d (n = 35) of antibiotic therapy. Gram-negative infections were encountered in majority of the neonates. Treatment failure occurred in 1 neonate in 10-d group and none in 14-d group. The duration of hospital stay was significantly less in 10-d group as compared to 14-d group (16 d vs. 23 d, p < 0.01).
Conclusions
Ten days of antibiotics in neonates with culture-positive sepsis, who have achieved clinical and microbiologic remission at day 7, is noninferior to 14 d of therapy. Larger adequately powered trials will address this issue with certainty.
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Acknowledgments
The authors thank Dr. Netra G for statistical analysis.
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AR collected the data; VS analyzed the data and wrote the manuscript; NS, NB conceptualized the idea and wrote the manuscript; PB conceptualized the idea, analyzed the data, and wrote the manuscript. NS is the guarantor for this paper.
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Reddy, A., Sathenahalli, V., Shivanna, N. et al. Ten Versus 14 Days of Antibiotic Therapy in Culture-Proven Neonatal Sepsis: A Randomized, Controlled Trial. Indian J Pediatr 89, 339–342 (2022). https://doi.org/10.1007/s12098-021-03794-6
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DOI: https://doi.org/10.1007/s12098-021-03794-6