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

Sint Franciscus Gasthuis0 个研究点目标入组 510 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•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 CRP and/or elevated PCT according to age-related normogram7) for which empiric broad-spectrum antimicrobial treatment was initiated and needs 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;For the specific PK-study, neonates also can participate when they fulfill the inclusion criteria and are given oral amoxicillin/clavulanic acid not for this specific trial but for another reason.

•* proven bloodstream infection
•* absence of blood culture (i.e. no blood culture taken)
•* severe localized infection such as meningitis, osteomyelitis, necrotizing enterocolitis (except pneumonia and urinary tract infection)
•* severe clinical sepsis on admission (compromised circulation; need for mechanical ventilation)
•* known (maternal) colonization with resistant bacteria such as MRSA, ESBL-producing bacteria
•* continuous need for central venous line (umbilical venous catheter, PICC)
•* severe hyperbilirubinaemia with need for phototherapy
•* clinicians* decision to continue with intravenous antibiotics because of other reasons
•* parents* inability to administer medication because of social reasons or language difficulties

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