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      RAIN study: a protocol for a randomised controlled trial evaluating efficacy, safety and cost-effectiveness of intravenous-to-oral antibiotic switch therapy in neonates with a probable bacterial infection

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          Abstract

          Introduction

          High morbidity and mortality rates of proven bacterial infection are the main reason for substantial use of intravenous antibiotics in neonates during the first week of life. In older children, intravenous-to-oral switch after 48 hours of intravenous therapy has been shown to have many advantages and is nowadays commonly practised. We, therefore, aim to evaluate the effectiveness, safety and cost-effectiveness of an early intravenous-to-oral switch in neonates with a probable bacterial infection.

          Methods and analysis

          We present a protocol for a multicentre randomised controlled trial assessing the non-inferiority of an early intravenous-to-oral antibiotic switch compared with a full course of intravenous antibiotics in neonates (0–28 days of age) with a probable bacterial infection. Five hundred and fifty patients will be recruited in 17 hospitals in the Netherlands. After 48 hours of intravenous treatment, they will be assigned to either continue with intravenous therapy for another 5 days (control) or switch to amoxicillin/clavulanic acid suspension (intervention). Both groups will be treated for a total of 7 days. The primary outcome will be bacterial (re)infection within 28 days after treatment completion. Secondary outcomes are the pharmacokinetic profile of oral amoxicillin/clavulanic acid, the impact on quality of life, cost-effectiveness, impact on microbiome development and additional yield of molecular techniques in diagnosis of probable bacterial infection.

          Ethics and dissemination

          This study has been approved by the Medical Ethics Committee of the Erasmus Medical Centre. Results will be presented in peer-reviewed journals and at international conferences.

          Trial registration number

          NCT03247920

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          Most cited references 20

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          Altering the intestinal microbiota during a critical developmental window has lasting metabolic consequences.

          Acquisition of the intestinal microbiota begins at birth, and a stable microbial community develops from a succession of key organisms. Disruption of the microbiota during maturation by low-dose antibiotic exposure can alter host metabolism and adiposity. We now show that low-dose penicillin (LDP), delivered from birth, induces metabolic alterations and affects ileal expression of genes involved in immunity. LDP that is limited to early life transiently perturbs the microbiota, which is sufficient to induce sustained effects on body composition, indicating that microbiota interactions in infancy may be critical determinants of long-term host metabolic effects. In addition, LDP enhances the effect of high-fat diet induced obesity. The growth promotion phenotype is transferrable to germ-free hosts by LDP-selected microbiota, showing that the altered microbiota, not antibiotics per se, play a causal role. These studies characterize important variables in early-life microbe-host metabolic interaction and identify several taxa consistently linked with metabolic alterations. PAPERCLIP: Copyright © 2014 Elsevier Inc. All rights reserved.
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            The iMTA Productivity Cost Questionnaire: A Standardized Instrument for Measuring and Valuing Health-Related Productivity Losses.

            Productivity losses often contribute significantly to the total costs in economic evaluations adopting a societal perspective. Currently, no consensus exists on the measurement and valuation of productivity losses.
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              Simplified antibiotic regimens compared with injectable procaine benzylpenicillin plus gentamicin for treatment of neonates and young infants with clinical signs of possible serious bacterial infection when referral is not possible: a randomised, open-label, equivalence trial.

              WHO recommends hospital-based treatment for young infants aged 0-59 days with clinical signs of possible serious bacterial infection, but most families in resource-poor settings cannot accept referral. We aimed to assess whether use of simplified antibiotic regimens to treat young infants with clinical signs of severe infection was as efficacious as an injectable procaine benzylpenicillin-gentamicin combination for 7 days for situations in which hospital referral was not possible.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2019
                9 July 2019
                : 9
                : 7
                Affiliations
                [1 ] departmentPediatrics, Division of Neonatology , Erasmus MC-Sophia Children’s Hospital , Rotterdam, The Netherlands
                [2 ] departmentPediatrics , Franciscus Gasthuis & Vlietland , Rotterdam, The Netherlands
                [3 ] departmentBiostatistics , Erasmus Medical Center , Rotterdam, The Netherlands
                [4 ] departmentPediatric Surgery , Erasmus MC-Sophia Children’s Hospital , Rotterdam, The Netherlands
                [5 ] departmentMedical Technology Assessment (iMTA) , Erasmus University Rotterdam , Rotterdam, The Netherlands
                [6 ] departmentDepartment of Development and Regeneration , KU Leuven , Leuven, Belgium
                Author notes
                [Correspondence to ] Fleur M Keij; f.keij@ 123456erasmusmc.nl
                Article
                bmjopen-2018-026688
                10.1136/bmjopen-2018-026688
                6615779
                31289068
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

                Product
                Funding
                Funded by: The Netherlands Organisation for Health Research and Development (ZonMW);
                Funded by: Innovatiefonds Zorgverzekeraars;
                Categories
                Paediatrics
                Protocol
                1506
                1719
                Custom metadata
                unlocked

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