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StopStop@HITH - Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course', for Children With Bacterial Infections Through Hospital-in-the-Home (HITH): a Basket Randomised Controlled Trial (RCT)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The aim of the StopStop@HITH study is to see if stopping antibiotics when symptoms stop is as good as finishing the course of antibiotics. The study will enrol children at the Royal Children's Hospital who are prescribed oral antibiotics after completing a course of intravenous (IV) antibiotics for the treatment of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) and lymphadenitis. The aims of the study are: * To determine if oral antibiotics can be safely stopped once symptoms stop in children with cellulitis (who have completed a course of IV antibiotics). * To assess feasibility of a larger study of other common infections across multiple hospitals. The participants parent/guardian will complete a daily symptom tracker for the duration of the prescribed oral antibiotic course and attend a telehealth appointment with the study team once the participants symptoms have resolved. There are additional follow up surveys at day 14, day 28 and day 180.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:

• Between the ages of ≥ 1 years and ≤ 17 years at enrolment

• Diagnosis of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) or lymphadenitis

• Prescription of oral antibiotics as a switch from IV antibiotics

Locations
Other Locations
Australia
Royal Children's Hospital
RECRUITING
Melbourne
Contact Information
Primary
A/Prof Penelope Bryant
penelope.bryant@rch.org.au
+61383416200
Backup
Lucy Hill
lucy.hill@mcri.edu.au
+61383416200
Time Frame
Start Date: 2026-08-18
Estimated Completion Date: 2028-06
Participants
Target number of participants: 200
Treatments
Experimental: Intervention arm
Oral antibiotics for the duration of the child's symptoms (minimum 3 days IV plus oral)
Active_comparator: Control arm
Oral antibiotics for the duration of the prescribed course (as per RCH Clinical Practice Guidelines for each infection)
Sponsors
Collaborators: Royal Children's Hospital
Leads: Murdoch Childrens Research Institute

This content was sourced from clinicaltrials.gov