7-day Compared With 10-day Antibiotic Treatment for Febrile Urinary Tract Infections in Children

Not Applicable

• Conditions: Urinary Tract Infections in Children
• Interventions: Other: Longer therapy duration; Other: Shorter therapy duration

• Registration Number: NCT03221504
• Lead Sponsor: Medical University of Warsaw

Brief Summary

The investigators aim to assess the effectiveness of a 7-day compared with a 10-day course of antibiotic treatment for febrile urinary tract infections (UTIs) in children. It is formulated a hypothesis that a 7-day course of antibiotic therapy is equally effective as a 10-day course of therapy and would entail a lower risk of adverse events and better compliance.

Detailed Description

In previously published European and global guidelines, there has been no consensus among experts regarding the duration of therapy for a febrile UTI. Depending on the recommendation, the duration of treatment should be between 7-14 days.

221 patients aged 3 months to 7 years with febrile UTIs (defined as a combination of fever and leukocyturia in urine sediment) will be randomly assigned to receive a 7-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded placebo) or a 10-day treatment arm (7 days of cefuroxime/cefuroxime axetil followed by 3 days of blinded cefuroxime axetil).

The primary outcome measure will be frequencies of recurrence and reinfection of UTI during the 6 months after the intervention. The secondary outcome measures will be antibiotic-associated diarrhea and compliance.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-14
• Study First Posted: 2017-07-18
• Study Start: 2018-01-01
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-20
• Primary Completion: 2019-07-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic therapy for 10 days	Longer therapy duration	After 7 days of cefuroxime treatment (oral, intravenous or sequential), patients from day 8 to day 10 will continue to receive the antibiotic (in blinded bottle).
Antibiotic therapy for 7 days	Shorter therapy duration	After 7 days of cefuroxime therapy (oral, intravenous or sequential), children from day 8 to day 10 will receive placebo (in blinded bottle).

Primary Outcome Measures

Name	Time	Method
frequencies of recurrence of UTI	3 months after intervention	New onset of symptomatic UTI within the 3 months follow-up period. The recurrence of a UTI is diagnosed when the next infection is caused by the same microorganism during 3 months following the treatment of a UTI.

Secondary Outcome Measures

Name	Time	Method
frequencies of reinfection of UTI	6 months after intervention	The reinfection of a UTI is diagnosed when the next infection is caused by a different bacteria.
antibiotic-associated diarrhoea (AAD), compliance	7 days after intervention	AAD is defined by the daily production of at least 3 loose or watery stools for at least 48 hours during antibiotic treatment and 7 days after administration of the antibiotic.; Compliance with the study protocol will be assessed by direct interview with the patient and/or caregiver and by measuring the amount of the fluid left in the bottle at the end of the intervention.

Trial Locations

Locations (2)

Children's Hospital for The Medical University of Warsaw; 🇵🇱 Warsaw, Poland

The Holy Family Specialistic Hospital; 🇵🇱 Warsaw, Poland