Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · May 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a single dose of intravenous (IV) antibiotics followed by two days of oral antibiotics for treating complicated urinary tract infections (UTIs) in children. Complicated UTIs can occur alongside symptoms like fever, vomiting, or a history of recurrent infections, and they often require hospitalization for IV antibiotics. The trial aims to find out if this one-dose approach is just as effective as the traditional method of giving three doses of IV antibiotics.

Children aged 3 months to 18 years who have certain symptoms and are determined by a doctor to need IV antibiotics may be eligible to participate. During the trial, all participants will receive a total of seven days of antibiotics. If the single-dose approach works well, it could help reduce hospital stays and the use of IV antibiotics, improving the overall care for children with complicated UTIs. Regardless of the outcome, the results of this study will help shape future treatment practices for these infections in children.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 3 months (corrected age) to 18 years
• • 2 or more of the following present: Fever (reported fever at home or measured fever of ≥38 degrees Celsius associated with the illness that triggered current ED presentation (eg fever may have been 18 hours prior to presentation but none since then because patient has been on maximal antipyretics - paracetamol or ibuprofen), Vomiting, Rigors, History of recurrent UTI, Urological abnormalities, Tachycardia
• • Urine sample available (Urine culture must have been collected prior to or within an hour of antibiotic treatment, either at the GP or ED - in order to assess urine culture as per below).
• • 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 \* In ED, only urine dipstick or urinalysis will be available. Once urine culture is available, to be included in the efficacy analysis, culture results must meet the following criteria: Positive urine culture result with no more than 2 species of microorganisms AND Spontaneously voided urine with ≥105 microorganisms per mL of urine or Suprapubic aspirate or urinary catheter with ≥104 microorganisms per mL of urine. In the absence of a positive urine culture, ultrasonographic findings supporting pyelonephritis (per reporting radiologist) will be accepted as evidence of a urinary tract infection.
• Exclusion Criteria:
• • Sepsis (requiring inotropic support or more than 20ml/kg of fluid bolus in Emergency Department)
• • Known allergy to all 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
• • Known impaired renal function, chronic renal failure or (renal transplant patients or a 10% increase in measured expected creatinine for age/height at ED presentation )
• • Unrepaired posterior urethral valves
• • Indwelling stent and fever
• • Previously enrolled participants in the CHOICE UTI trial.
• • No available oral antibiotic option for this UTI: urine culture result already available and multi-resistant organism with susceptibility only to IV antibiotics or known intolerance to oral antibiotics (previous UTI with multi-resistant organism not an exclusion)
• • Previous IV antibiotics for same UTI episode eg interhospital transfer whereby significant time has passed since first dose IV
• • Patients with clinically suspected renal abscess e.g., extreme renal tenderness, out of keeping with pyelonephritis (clinically determined).
• • Clinician does not intend on prescribing a course of IV antibiotics but plans on only giving a single dose from the outset
• • Recurrence of urinary tract infection within 2 weeks
• • Unable to obtain consent
• • Patient is pregnant