Department of Pediatrics, Indira Gandhi Institute of Child Health, Karnataka, 560029, Bangalore, India.
Department of Neonatology, Indira Gandhi Institute of Child Health, Bangalore, Karnataka, India.
Indian J Pediatr. 2022 Apr;89(4):339-342. doi: 10.1007/s12098-021-03794-6. Epub 2021 Jun 7.
To compare the efficacy of 10 d versus 14 d of antibiotic therapy in neonates with culture-positive sepsis.
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.
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).
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.
比较培养阳性败血症新生儿 10 天与 14 天抗生素治疗的疗效。
将培养阳性败血症新生儿随机分为 10 天或 14 天抗生素治疗组。这些新生儿在出院后 28 天内进行随访，以评估治疗失败情况。研究的主要结局为治疗失败，定义为出院后 4 周内因相同血培养物具有相似药敏谱而再次入住新生儿重症监护病房，或任何因败血症征象但血培养阴性而再次入院。
共有 70 例新生儿随机接受 10 天（n=35）或 14 天（n=35）抗生素治疗。大多数新生儿感染的病原体为革兰氏阴性菌。10 天组有 1 例患儿发生治疗失败，而 14 天组无患儿发生治疗失败。与 14 天组相比，10 天组的住院时间明显缩短（16 天 vs. 23 天，p<0.01）。
对于培养阳性败血症、在第 7 天达到临床和微生物学缓解的新生儿，使用 10 天抗生素治疗与 14 天治疗相比并不劣效。更大规模的、充分有力的试验将确定地解决这一问题。
