From the Department of Neonatology, Institute of Child Health, Sir Ganga Ram Hospital, New Delhi, India.
Pediatr Infect Dis J. 2022 Feb 1;41(2):156-160. doi: 10.1097/INF.0000000000003314.
Optimal duration of antibiotic therapy in Gram-negative bacterial (GNB) sepsis in non-VLBW infants has not been specifically evaluated in previous studies.
This was an open labeled noninferiority randomized controlled trial. Non-VLBW infants with GNB sepsis without meningitis whose blood culture were sterile after day 7 of treatment and who were in clinical remission on day 9 of appropriate antibiotic were randomized to short duration (SDR) group and long duration (LDR) group. Infants in SDR group and LDR group received antibiotic therapy for 10 days and 14 days respectively. Primary objective was to compare treatment failure. Secondary objectives were to compare duration of hospitalization, complications of intravenous (IV) therapy and its duration, episodes of new-onset sepsis and all-cause mortality.
Of 222 infants with GNB sepsis, 58 eligible infants were randomized in each group and 113 of these were analyzed. There was no difference in proportion of infants with multidrug-resistant (MDR) organism in SDR versus LDR group [33(60%) versus 32(55.1%) (P = 0.84)]. There were no treatment failures in either group. Median (IQR) duration of hospital stay was higher in LDR group as compared with SDR group: 20(18, 23) versus 16(13, 20) days (P < 0.001). Infants in LDR group required IV therapy for a longer duration as compared with SDR group mean (SD): 15.2(1.2) versus 10.9(0.8) days (P < 0.001). Median (IQR) episodes of extravasation were higher in LDR group: 5(4.7) versus 3(2.3) (P < 0.001). There was no difference in episodes of phlebitis and hematoma. No infants had died on follow up.
In suitably selected non-VLBW infants with Gram-negative sepsis, 10 days therapy is noninferior to 14 days therapy.
在非极低出生体重儿（VLBW）革兰氏阴性菌（GNB）败血症中，尚未在之前的研究中专门评估抗生素治疗的最佳持续时间。
这是一项开放标签的非劣效性随机对照试验。患有 GNB 败血症且无脑膜炎、治疗第 7 天后血培养无菌且第 9 天临床缓解的非 VLBW 婴儿被随机分配至短疗程（SDR）组和长疗程（LDR）组。SDR 组和 LDR 组的婴儿分别接受 10 天和 14 天的抗生素治疗。主要目标是比较治疗失败率。次要目标是比较住院时间、静脉（IV）治疗及其持续时间、新发病灶败血症和全因死亡率的并发症。
在 222 例 GNB 败血症婴儿中，58 例符合条件的婴儿被随机分配到每组，其中 113 例进行了分析。SDR 组和 LDR 组中多重耐药（MDR）病原体的婴儿比例无差异[33（60%）与 32（55.1%）（P=0.84）]。两组均无治疗失败。与 SDR 组相比，LDR 组的住院时间中位数（IQR）更高：20（18，23）天与 16（13，20）天（P<0.001）。LDR 组婴儿的 IV 治疗时间明显长于 SDR 组：15.2（1.2）天与 10.9（0.8）天（P<0.001）。LDR 组的中位（IQR）外渗次数更高：5（4.7）次与 3（2.3）次（P<0.001）。两组静脉炎和血肿的发作次数无差异。随访期间无婴儿死亡。
在适当选择的非 VLBW 革兰氏阴性败血症婴儿中，10 天治疗与 14 天治疗相比不劣效。
