A Multicenter Randomized Controlled Trial of Antibiotic Treatment in Children With Urinary Tract Infections: Oral Amoxicillin/Clavulanic Acid vs Initial iv Ceftriaxone.
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 440
- Primary Endpoint
- 1. Duration of fever (>38°),
Study Overview
Brief Summary
The main objectives of the study are
- to compare the efficacy of oral vs initial iv antibiotic treatment in children with a first episode of UTI
- to assess the diagnostic power of the various imaging technique (renal ultrasonogram, voiding cystourethrogram, and renal scanning with technetium-99m-labeled dimercaptosuccinic acid)
Detailed Description
Background. Upper urinary tract infections (UTIs) are common in children, but attitudes toward the diagnosis and the acute treatment are heterogeneous among pediatricians and pediatric nephrologists. In effect the choice of antibiotic regimens is largely empirical and based on local practice, with no rationale for the choice of oral or parenteral administration. A retrospective study (1993-97) showed that in 1333 (36 % M) hospitalized children because of a prove UTI, parenteral antibiotic was given initially to 756 (57.2%) of the population studied.
We are aware of a unique randomized clinical trial, which has shown no differences in the short term (mean time to defervescence) and long term outcomes (symptomatic reinfections and renal scarring) of children receiving oral cefixime for 14 days versus vs initial iv cefotaxime for 3 days, followed by oral cefixime for 11 days.
The management of patients with UTI consists not only in antibiotic treatment of acute episodes, but also in the global evaluation of any risk factors. Current recommendations for imaging of the urinary tract are not based on prospective studies of outcomes (development of renal scars). A recent publication (Hoberman et al) suggests that renal ultrasonography and DMSA scanning at the time of acute illness are of limited value and recommends the routine use of voiding cystourethrography to identify children with reflux.
Aims.
Main objective of the study is:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Months to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age between 2 months and 6 years,
- •normal renal function
- •first episode of upper UTI (fever, 2 consecutive positive urinalysis, later confirmed by 2 cultures and high blood inflammation indices)
Exclusion Criteria
- •documented previous urinary tract malformation (prenatal ultrasound)
- •seriously compromised general conditions (such as sepsis or vomit)
- •hypersensitivity to the antibiotics considered.
Outcomes
Primary Outcomes
1. Duration of fever (>38°),
3. Reduction of the blood inflammatory indices,
2. Sterilization of the urine,
4. Incidence of renal scarring documented at 12 month.
Secondary Outcomes
No secondary outcomes reported