RecruitingPhase 4ACTRN12614000958684

A pilot study on length of antibiotics for children hospitalized with pneumonia

Does a longer course (13-14 days) of antibiotics compared to a shorter course (5-6 days), improve short and medium-term clinical outcomes of children hospitalised with severe community-acquired pneumonia


Sponsor

Menzies School of Health Research

Enrollment

20 participants

Start Date

Nov 1, 2014

Study Type

Interventional

Conditions

Summary

This pilot study is to define the acceptability of short vs. long course of antibiotics for the treatment of young children hospitalized with pneumonia


Eligibility

Sex: Both males and femalesMin Age: 3 MonthssMax Age: 6 Yearss

Inclusion Criteria3

  • (a) Hospitalised children who have been unwell for <7-days with pneumonia
  • (b) Alveolar consolidation on CXR; and
  • (c) After 48-72 hours of IV penicillin/ampicillin the children are afebrile, with improved respiratory symptoms and signs, SpO2 >92% in air and are ready to be switched to oral antibiotics

Exclusion Criteria5

  • Presence of one or more:
  • (a) underlying chronic illness (not asthma): chronic lung disease of infancy, bronchiectasis, cystic fibrosis, congenital heart disease, or immunodeficiency
  • (b) complicated pneumonia (effusion, empyema, abscess); non-alveolar pneumonia; those requiring assisted ventilation or circulatory support; or where a treatment course of IV antibiotics other than penicillin/ampicillin has been used (eg. anti-staphylococcal antibiotics, cephalosporins or macrolides);
  • (c) extra-pulmonary infection requiring antibiotic therapy (eg. meningitis); or
  • (d) beta-lactam antibiotic allergy

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Interventions

Arm 1: Twice daily oral amoxycillin-clavulanic acid (22.5 mg/kg/dose) for 11 days Arm 2: Twice daily oral amoxycillin-clavulanic acid (22.5 mg/kg/dose) for 3 days followed by oral placebo for 8 da

Arm 1: Twice daily oral amoxycillin-clavulanic acid (22.5 mg/kg/dose) for 11 days Arm 2: Twice daily oral amoxycillin-clavulanic acid (22.5 mg/kg/dose) for 3 days followed by oral placebo for 8 days These treatments are administered after 48-72 hours of IV penicillin/ampicillin, the children are afebrile, with improved respiratory symptoms and signs, SpO2 >92% in air and are ready to be switched to oral antibiotics


Locations(1)

Royal Darwin Hospital - Tiwi

NT, Australia

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