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Switch from intravenous-to-oral antibiotics in neonatal probable and proven early-onset infection: a prospective population-based real-life multicentre cohort study
  1. Emma Louise Malchau Carlsen1,2,
  2. Kia Hee Schultz Dungu3,
  3. Anna Lewis4,
  4. Nadja Hawwa Vissing3,
  5. Lise Aunsholt1,5,
  6. Simon Trautner1,
  7. Hristo Stanchev6,
  8. Gholamreza Krog Dayani7,
  9. Anne-Janet L Pedersen8,
  10. Mia Bjerager4,
  11. Maria De Salas9,
  12. Kristian Vestergaard10,
  13. Pernille Pedersen2,
  14. Niels Frimodt-Møller11,
  15. Gorm Greisen1,12,
  16. Bo Mølholm Hansen4,12,
  17. Ulrikka Nygaard3,12
  1. 1Department of Neonatology, Rigshospitalet, University of Copenhagen, Kobenhavn, Denmark
  2. 2Department of Pediatrics, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark
  3. 3Department of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Kobenhavn, Denmark
  4. 4Department of Pediatrics, Hillerød Hospital, University of Copenhagen, Hillerod, Denmark
  5. 5Comparative Pediatrics and Nutrition, University of Copenhagen, Copenhagen, Denmark
  6. 6Department of Pediatrics, Slagelse Hospital, Slagelse, Denmark
  7. 7Department of Pediatrics and Adolescence, Roskilde Hospital, Roskilde, Denmark
  8. 8Department of Pediatrics, Nykøbing F Sygehus, Nykobing, Denmark
  9. 9Department of Pediatrics, Herlev Hospital, University of Copenhagen, Herlev, Denmark
  10. 10Department of Pediatrics, Holbaek Sygehus, Holbaek, Denmark
  11. 11Department of Microbiology, Rigshospitalet, University of Copenhagen, Kobenhavn, Denmark
  12. 12Institute of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Kobenhavn, Denmark
  1. Correspondence to Dr Emma Louise Malchau Carlsen, Department of Neonatology, Rigshospitalet, Kobenhavn 2100, Denmark; emma.louise.malchau.carlsen{at}regionh.dk

Abstract

Objective To evaluate the implementation of switch from intravenous-to-oral antibiotic therapy with amoxicillin in neonates with early-onset infection (EOI).

Design, setting and patients A population-based multicentre cohort study. All term-born neonates with EOI were prospectively included between 1 December 2018 to 30 November 2020.

Intervention Intravenous-to-oral switch antibiotic therapy in clinically stable neonates.

Main outcome measures The primary outcome was readmission due to infection. Secondary outcomes were days of hospitalisation and antibiotic use in the pre-implementation versus post implementation period.

Results During 2 years, 835 neonates commenced antibiotics for EOI (1.5% (95% CI 1.4% to 1.6%)) of all term live births). Of those, 554 (66%) underwent a full course of treatment. There were 23 episodes of culture-proven infection (0.42 per 1000 term live births (95% CI 0.27 to 0.63)). A total of 478 of 531 (90%) neonates with probable infection underwent switch therapy. None was readmitted due to infection. The median duration of hospitalisation was 3.0 days (IQR 2.5–3.5) and 7.4 days (IQR 7.0–7.5) in the switch and intravenous therapy groups, respectively. According to antibiotic surveillance data, 1.2% underwent a full course of treatment following implementation of oral switch therapy (2019–2020), compared with 1.2% before (2017–2018).

Conclusion In clinical practice, switch therapy was safe and used in 9 of 10 neonates with probable EOI. Knowledge of the safety of antibiotic de-escalation is important as home-based oral therapy ameliorates the treatment burden for neonates, caregivers and healthcare systems. Despite the ease of oral administration, implementation of switch therapy did not increase the overall use of antibiotics.

  • Neonatology
  • Infectious Disease Medicine
  • Sepsis
  • Infant Welfare

Data availability statement

Data are available upon reasonable request. Researchers who provide a methodologically sound proposal will be granted access to a full copy of individual deidentified data. The data will be available from 3 months after the publication of the study, ending 5 years after publication. Proposals should be directed to the corresponding author of this article, and access can be granted after the proposal is approved by the trial steering committee.

http://dx.doi.org/10.1136/archdischild-2023-325386

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    Data availability statement

    Data are available upon reasonable request. Researchers who provide a methodologically sound proposal will be granted access to a full copy of individual deidentified data. The data will be available from 3 months after the publication of the study, ending 5 years after publication. Proposals should be directed to the corresponding author of this article, and access can be granted after the proposal is approved by the trial steering committee.

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    Footnotes

    • Contributors ELMC, KHSD, AL, NHV, GG, BMH and UN conceptualised and designed the study, designed the data collection instruments, collected the data, carried out the initial analyses, drafted the initial manuscript, and critically reviewed and revised the manuscript. NF-M conceptualised and designed the study and critically reviewed and revised the manuscript. LA, ST, HS, GKD, A-JLP, MB, MDS, KV and PP were involved in the data collection and critically reviewed and revised the manuscript. All authors had access to the data, approved the final manuscript as submitted and agreed to be accountable for all aspects of the work. Guarantor is ELMC.

    • Funding This study was funded by Innovation Fund, Denmark (0176-00020B).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.