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Shorter vs. longer antibiotics for kids with pneumonia: which works best?

NCT ID NCT02783859

Disease control Sponsor: Menzies School of Health Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving children a longer course of antibiotics (amoxicillin-clavulanic acid) after hospitalization for pneumonia leads to better recovery compared to a shorter course. It involved 314 children aged 3 months to 5 years in Australia. The goal was to see if longer treatment reduces long-term breathing problems or lung damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

314 people

The number who actually took part.

Started

Jun 2016

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 months to 5 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Hospitalised children aged 3-mo to 5-yrs (in Darwin, children have to be Indigenous) 2. Have features of severe pneumonia on admission (temperature \>37.5 celsius or a history of fever at home or observed at the referring clinic, age-adjusted tachypnoea \[respiratory rate\>50 if \<12-months; respiratory rate\>40 if \>12-months\] with chest wall recession and/or oxygen saturation \<92% in air), and consolidation on chest X-ray as diagnosed by treating clinician 3. After 1-3 days of IV antibiotics, are afebrile, with improved respiratory symptoms and signs, oxygen saturation\>90% in air and are ready to be switched to oral amoxicillin-clavulanate, and 4. Have symptoms of no longer than 7 days at point of hospitalisation. Exclusion Criteria: 1. Current wheeze 2. Underlying chronic illness other than asthma (e.g. bronchiectasis, cyanotic congenital heart disease or cardiac failure, neuromuscular disorders, immunodeficiency) that could potentially influence the current illness 3. Severe malnutrition (weight-for-height Z-score \<-3) 4. Complicated (effusion, empyema or abscess) pneumonia, including tuberculosis 5. Extra-pulmonary infection requiring antibiotic therapy (e.g. meningitis) 6. Beta-lactam allergy 7. Previously enrolled 8. Lack a mobile phone and/or unable to return for follow-up clinic visits during the next 24 months

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Conditions

The condition(s) this trial relates to.

pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pneumonia

Contacts and locations

Locations

  • Menzies School of Health Research

    Darwin, Northern Territory, 0812, Australia

  • Sabah Women and Children's Hospital

    Kota Kinabalu, Sabah, 88996, Malaysia

  • Sarawak General Hospital

    Sibu, Sarawak, 96000, Malaysia

  • Starship Children's Hospital & KidzFirst Hospital

    Auckland, Auckland, 1142, New Zealand

  • University Malaya Medical Centre and Klang Hospital

    Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

More trials for these conditions

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