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Comparison of oral amoxicillin and intravenous benzyl penicillin for community acquired pneumonia in children (PIVOT trial): a multicentre pragmatic randomised controlled equivalence trial
  1. Maria Atkinson1,
  2. Monica Lakhanpaul2,
  3. Alan Smyth3,
  4. Harish Vyas4,
  5. Vivienne Weston4,
  6. Jabulani Sithole5,
  7. Victoria Owen5,
  8. Katharine Halliday4,
  9. Helen Sammons6,
  10. Jo Crane7,
  11. Narayan Guntupalli8,
  12. Lynda Walton9,
  13. Titus Ninan10,
  14. Anu Morjaria11,
  15. Terence Stephenson1
  1. 1
    Division of Child Health, University of Nottingham, University Hospital Queen’s Medical Centre, Nottingham, UK
  2. 2
    Division of Child Health, University of Leicester, Leicester, UK
  3. 3
    Division of Child Health, City Hospital, Nottingham, UK
  4. 4
    University Hospital, Queen’s Medical Centre, Nottingham, UK
  5. 5
    Trent Research and Development Support Unit, University of Nottingham, Nottingham, UK
  6. 6
    Division of Child Health, Derby Children’s Hospital, Derby, UK
  7. 7
    New Cross Hospital, Wolverhampton, UK
  8. 8
    United Lincolnshire Hospitals NHS Trust, Lincoln, UK
  9. 9
    King’s Mill Hospital, Mansfield, UK
  10. 10
    Birmingham Heartlands and Solihull Hospital, Birmingham, UK
  11. 11
    University Hospital of North Staffordshire, Stoke on Trent, UK
  1. Dr Maria Atkinson, Paediatric Respiratory Unit, University Hospital, Queen’s Medical Centre, Nottingham NG7 2UH, UK; maria{at}doctors.org.uk

Abstract

Objective: To ascertain whether therapeutic equivalence exists for the treatment of paediatric community acquired pneumonia by the oral and intravenous (IV) routes.

Methods: A multicentre pragmatic randomised controlled non-blinded equivalence trial was undertaken in eight paediatric centres in England (district general and tertiary hospitals). Equivalence was defined as no more than a 20% difference between treatments of the proportion meeting the primary outcome measure at any time. 246 children who required admission to hospital and had fever, respiratory symptoms or signs and radiologically confirmed pneumonia were included in the study. Exclusion criteria were wheeze, oxygen saturations <85% in air, shock requiring >20 ml/kg fluid resuscitation, immunodeficiency, pleural effusion at presentation requiring drainage, chronic lung condition (excluding asthma), penicillin allergy and age <6 months. The patients were randomised to receive oral amoxicillin for 7 days (n = 126) or IV benzyl penicillin (n = 120). Children in the IV group were changed to oral amoxicillin after a median of six IV doses and received 7 days of antibiotics in total. The predefined primary outcome measure was time for the temperature to be <38°C for 24 continuous hours and oxygen requirement to cease. Secondary outcomes were time in hospital, complications, duration of oxygen requirement and time to resolution of illness.

Results: Oral amoxicillin and IV benzyl penicillin were shown to be equivalent. Median time for temperature to settle was 1.3 days in both groups (p<0.001 for equivalence). Three children in the oral group were changed to IV antibiotics and seven children in the IV group were changed to different IV antibiotics. Median time to complete resolution of symptoms was 9 days in both groups.

Conclusion: Oral amoxicillin is effective for most children admitted to hospital with pneumonia (all but those with the most severe disease who were excluded from this study). Prior to this study, the British Thoracic Society guidelines on childhood pneumonia could not draw on evidence to address this issue. This will spare children and their families the trauma and pain of cannulation, and children will spend less time in hospital.

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Footnotes

  • The research was funded by the British Lung Foundation who had no input into the study design or data collection.

  • Competing interests: None.

  • There are no additional contributors.

    The study protocol was reviewed and approved by all participating hospitals (multicentre research ethical approval was given by the West Midlands Ethics Committee).

    Trial registration: N0192107553 - National Research Register.

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