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Could a simple pill replace the needle for kids with bone infections?

NCT ID NCT04538053

Disease control Sponsor: Murdoch Childrens Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether giving children with bone and joint infections antibiotics only by mouth works just as well as starting with IV antibiotics for a few days and then switching to pills. About 285 children aged 1 to 18 from hospitals in Australia and New Zealand will take part. The goal is to see if the simpler oral-only approach leads to full recovery after 3 months.

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

About 285 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

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

1 year to 18 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: * Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria. Exclusion Criteria: 1. Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal) 2. Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score) 3. Concomitant severe, invasive infection e.g. necrosing fasciitis 4. Complicated infection (e.g. presence of prosthetic material; large subperiosteal (\>3mm) or soft tissue abscess without surgical intervention; infection secondary to or complicated by trauma) 5. History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins 6. Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection 7. Prior episode of OM or SA 8. Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency) 9. Prior enrolment in the trial 10. Current recipient of another investigational product as part of a clinical trial

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Conditions

The condition(s) this trial relates to.

bacterial arthritis infective arthritis osteomyelitis

As listed by the trial registrant

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

Bone and joint infection Bone infection Osteomyelitis Septic arthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Christchurch Hospital

    RECRUITING

    Christchurch, 8011, New Zealand

  • John Hunter Children's Hospital

    RECRUITING

    New Lambton Heights, New South Wales, 2305, Australia

  • Nepean Hospital

    RECRUITING

    Kingswood, New South Wales, 2747, Australia

  • Perth Children's Hospital

    RECRUITING

    Perth, Western Australia, 6009, Australia

  • Queensland Children's Hospital

    RECRUITING

    Brisbane, Queensland, 4101, Australia

  • Royal Darwin Hospital

    RECRUITING

    Darwin, Northern Territory, 0811, Australia

  • Sydney Children's Hospital Network

    RECRUITING

    Sydney, New South Wales, 2031, Australia

  • The Children's Hospital at Westmead

    ACTIVE_NOT_RECRUITING

    Sydney, New South Wales, 2145, Australia

  • The Royal Children's Hospital

    RECRUITING

    Melbourne, Victoria, 3051, Australia

  • Women's and Children's Hospital

    RECRUITING

    Adelaide, South Australia, 5006, Australia

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Other studies related to the condition(s) this trial covers.