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

Medical University of Warsaw

Status: Unknown

Conditions: Urinary Tract Infections in Children

Treatments: Other: Longer therapy duration; Other: Shorter therapy duration

Study type: Interventional

Funder types: Other

Identifiers

NCT03221504

WUM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 221 estimated patients

Sex: All

Ages: 3 months to 7 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (must have all):

• children aged from 3 months to 7 years
• clinical diagnosis of a febrile UTI at presentation according to urinalysis (white blood cells in the sediment >10 in the field of view);
• fever ≥38°C
• positive urine collection with sensitivity for cefuroxime
• treatment cefuroxime or cefuroxime axetil for 7 days

Exclusion Criteria (must have one):

• history of a UTI in the last 3 months
• prophylaxis for UTI
• antibiotic therapy in the last month
• known allergy to the study drugs
• immunosuppression therapy
• disease with immune deficiency
• children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis
• severe obstructive uropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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221 participants in 2 patient groups

Antibiotic therapy for 10 days

Active Comparator group

Description:

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).

Treatment:

Other: Longer therapy duration

Antibiotic therapy for 7 days

Experimental group

Description:

After 7 days of cefuroxime therapy (oral, intravenous or sequential), children from day 8 to day 10 will receive placebo (in blinded bottle).

Treatment:

Other: Shorter therapy duration