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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000958684

Acronym

HOP-Pilot

Enrollment

Registered

2014-09-08

Start date

2014-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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 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

_x0007_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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

3 Months to 6 Years

Healthy volunteers

Inclusion criteria

(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 criteria

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

Outcome results