INTRAVENOUS-TO-ORAL ANTIBIOTIC SWITCH THERAPY FOR SUSPECTED NEONATAL BACTERIAL INFECTIONS: CLINICAL EFFICACY, SAFETY AND COST-EFFECTIVENESS

Stichting Rotterdams Onderzoeksconsortium Kindergeneeskunde0 个研究点目标入组 600 人开始时间: 2017年2月16日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•Neonates, = 35+0 weeks of gestation, 0-28 days old, = 2.0 kg.
•probable bacterial infection (clinical symptoms and/or maternal risk factors and elevated inflammatory parameters (elevated PCT according to age-related normogram and/or elevated CRP)) for which empiric broad-spectrum antimicrobial treatment was initiated and need to be continued for > 48 hours at the discretion of the treating physician
•reassuring level and trends of inflammatory parameters 48-72 hours after initiation of antimicrobial treatment
•clinically stable
•tolerates oral feeding and/or liquids without overt vomiting
•written informed consent of parents or legal representatives
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 600
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•proven bloodstream infection, failed blood culture
•severe localized infection such as meningitis, osteomyelitis, necrotizing enterocolitis (pneumonia and urinary tract infection excluded)
•severe clinical sepsis on admission (compromised circulation; need for mechanical ventilation)
•known colonization with resistant bacteria such as MRSA, ESBL-producing bacteria
•continuous need for central venous line (umbilical venous catheter, PICC)
•clinicians’ decision to continue with intravenous antibiotics because of other reasons
•parents’ inability to administer medication because of social reasons or language difficulties

发起方

Stichting Rotterdams Onderzoeksconsortium Kindergeneeskunde