Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

• Status: Not yet recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Urinary tract infections (UTI) are commonly encountered in children, with 7% diagnosed with at least one UTI by the age of 19 years. The evidence for treatment of uncomplicated UTI is clear; oral antibiotics are as good as intravenous (IV) antibiotics, usually for a total of 7 days. Complicated UTIs (cUTIs) on the other hand, are common reasons for hospital admissions for IV antibiotics and constitute a major burden for healthcare systems. There is considerable variation in care for children who present with UTI and have complicating features such as vomiting, dehydration, urological abnormalities or have a previous history of UTI. Australian and international guidelines lack clear, evidence-based recommendations to guide treatment in this group. Without gold standard evidence, these children will continue to receive unnecessary IV antibiotics, longer hospital stays and poorer health outcomes.

This multicentre, non-inferiority randomised trial will investigate if a single dose of IV antibiotics and switching early to oral antibiotics is as good as 3 days of IV antibiotics. In other words, this study will compare if a single dose of IV antibiotics plus two days oral antibiotics (Early Switch) is as clinically effective as 3 days IV antibiotics in resolving UTI symptoms at 72 hours after the first dose of IV antibiotics, for complicated UTIs in children presenting to the Emergency Department (ED). All participants will receive a total of 7 days of antibiotics for the complicated urinary tract infection. If 1 dose and early switch to oral antibiotics is found to be as good as 3 days, the duration of IV antibiotics for complicated UTI can be reduced along with avoidance of the inherent risks of unnecessary hospital admission by administering a single IV dose in an outpatient/ED setting. On the other hand if a single IV dose results in prolonged symptoms or treatment failure, this will inform practice for the proportion of children who have a single dose of IV antibiotics in the ED and are sent home on oral antibiotics. Regardless of the outcome, this trial will inform clinical practice for complicated UTI to improve health outcomes for this group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Murdoch Childrens Research Institute
• Collaborator: Royal Children's Hospital
• Treatments: Anti-Bacterial Agents; Cephalexin; Gentamicins; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine

Criteria

Inclusion Criteria:

3 months (corrected age) to 18 years

• 3 or more of the following present: Fever, Vomiting, Rigors, History of recurrent UTI, Urological abnormalities, Tachycardia

• Abnormal urinary dipstick leucocyte esterase >1+ or nitrite positive OR ≥5 White Blood Cells (WBCs) per high-power field in centrifuged urine OR≥ 10 White Blood Cells (WBCs) per mm3 in uncentrifuged urine and bacteriuria with any bacteria per high-power field

• ED clinician determines the child requires treatment with IV antibiotics

Exclusion Criteria:

• Sepsis (requiring inotropic support or more than 20mls/kg of fluid bolus)

• Known allergy to the once daily study drug options (gentamicin or ceftriaxone or amikacin)

• If the patient has another co-existing condition which requires (based on established evidence-based guidelines) more than 1 dose of IV antibiotics eg meningitis

• Impaired renal function (abnormal creatinine at ED presentation or known renal impairment or renal transplant patients)

• Unrepaired posterior urethral valves

• Indwelling stent and fever

• Patients with known pelvic ureteric junction obstruction (PUJ obstruction) where pyonephrosis (pus in the renal pelvis) is a potential diagnosis and cannot be ruled out (ultrasound ruling out pyonephrosis prior to randomisation)

• Patients with known vesico ureteric junction obstruction (VUJ obstruction) where pyonephrosis (pus in the renal pelvis) is a potential diagnosis and cannot be ruled out (require ultrasound ruling out pyonephrosis prior to randomisation)