Stop the pills when symptoms vanish? landmark trial for Kids' infections
NCT ID NCT07532941
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times
Summary
This study tests whether children with bacterial infections like urinary tract infections, cellulitis, or pneumonia can safely stop oral antibiotics once their symptoms go away, instead of finishing the entire course. About 200 children aged 1 to 17 who have already received IV antibiotics will be enrolled. Parents will track symptoms daily, and the study will compare how many children need to restart antibiotics within 28 days between the two approaches.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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1 year to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Between the ages of ≥ 1 years and ≤ 17 years at enrolment 2. Diagnosis of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) or lymphadenitis 3. Prescription of oral antibiotics as a switch from IV antibiotics Exclusion Criteria: 1. Clinician determined need for \>10-day oral antibiotic course 2. Child with immunosuppression (e.g. as a result of cancer treatment) 3. Second episode of same bacterial infection within the last 28 days 4. Child is unable to take oral antibiotics 5. Previous enrolment in StopStop@HITH 6. Parent/guardian does not speak English 7. Clinician determined need for 10-day course of oral antibiotics for treatment/clearance of streptococcal infection 8. UTI only: known impaired renal function (e.g. renal transplant patients or known chronic renal failure) 9. LRTI only: known chronic respiratory condition (e.g. cystic fibrosis or bronchiectasis) or need for long term respiratory support (e.g. home oxygen, Continuous Positive Airway Pressure \[CPAP\] or tracheostomy); empyema or lung abscess
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Royal Children's Hospital
RECRUITINGMelbourne, Victoria, 3052, Australia
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