4.5 Article

Ten Versus 14 Days of Antibiotic Therapy in Culture-Proven Neonatal Sepsis: A Randomized, Controlled Trial

Journal

INDIAN JOURNAL OF PEDIATRICS
Volume 89, Issue 4, Pages 339-342

Publisher

SPRINGER INDIA
DOI: 10.1007/s12098-021-03794-6

Keywords

Neonate; Sepsis; Antibiotic

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The study found that 10 days of antibiotics in neonates with culture-positive sepsis, who have achieved clinical and microbiologic remission at day 7, is noninferior to 14 days of therapy. Larger trials are needed to confirm these findings.
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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