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

Plain Language Summary

Simplified for easier understanding

This study looks at whether a shorter course of antibiotics works just as well as a longer course for young children who are hospitalized with a confirmed lung infection (pneumonia) and are starting to get better after initial IV treatment. Fewer days of antibiotics could mean faster recovery and fewer side effects. You may be eligible if: - Your child is between 3 months and 6 years old - Your child was admitted to hospital with pneumonia that started less than 7 days before admission - A chest X-ray shows a clear area of lung consolidation - After 48–72 hours of IV penicillin, your child has no fever, their breathing has improved, oxygen levels are above 92%, and they are ready to switch to oral antibiotics You may NOT be eligible if: - Your child has an underlying chronic illness such as bronchiectasis, cystic fibrosis, congenital heart disease, or an immune deficiency - Your child has a complicated pneumonia (with fluid around the lung, abscess, or requiring breathing support) - Your child has an infection outside the lungs requiring antibiotics (e.g., meningitis) - Your child is allergic to beta-lactam antibiotics (penicillin type) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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ACTRN12614000958684