Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection

Recruiting

• Conditions: Urinary Tract Infections in Children
• Interventions: Drug: Oral antibiotic therapy

• Registration Number: NCT05819229
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The goal of this prospective study is to investigate whether oral antibiotic therapy alone is feasible and safe in clinically stable children aged 4 weeks to 2 months without any past high-risk medical history with a suspected or confirmed urinary tract infection.

Detailed Description

All children aged 4 weeks to 2 months with a suspected urinary tract infection will be observed and examined by physicians and nurses as recommended by current guidelines. Children needing empirical antibiotic therapy will be admitted. The remaining will be contacted by phone if the urine culture is positive, and antibiotic therapy will be initiated if a urinary tract infection is still suspected due to persistent symptoms.

Clinically stable (see eligibility criteria) children without any past high-risk medical history (see eligibility criteria) will initiate oral antibiotic therapy. As empirical oral therapy, amoxicillin-clavulanic acid 50 mg/kg/day divided into 3 doses will be used. If the sensitivity pattern is available, a smaller-spectrum antibiotic can be used instead. If these children at any time point become clinically unstable or have a positive blood culture without suspected contamination, parenteral antibiotic therapy will be initiated. As empirical parenteral therapy, gentamicin 5 mg/kg once daily and ampicillin 100 mg/kg/day divided into 3 doses will be used. If the sensitivity pattern is available, another parenteral antibiotic regime can be used instead.

Admitted children can be sent home when they have clinically improved (judged by the physician) and have been hospitalized at least until the ward round the following day. Parents will be informed to contact the pediatric emergency department immediately if the child worsens or does not tolerate the antibiotics.

A physical or virtual follow-up will be conducted on day 3 (approximately 72 hours after treatment initiation) to ensure clinical improvement and treatment adherence. If needed, antibiotic therapy will be changed according to the sensitivity pattern. Children with a negative urine culture will be informed to stop antibiotic therapy.

The duration of antibiotic therapy will be 10 days. All children will undergo a renal ultrasound within the treatment period.

The above recommendations has been implemented as routine care. Hence, no parental consent is needed.

Study Timeline

• Study First Submitted: 2023-02-22
• Study Start: 2023-02-27
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral antibiotic therapy	Oral antibiotic therapy	Clinically stable (see eligibility criteria) children without any past high-risk medical history (see eligibility criteria) will initiate oral antibiotic therapy.

Primary Outcome Measures

Name	Time	Method
Number of days admitted related to urinary tract symptoms	Within 28 days after treatment initiation
Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause	Within 28 days after end of treatment

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with a recurrent urinary tract infection regardless of the pathogen or death of any cause.	Within 100 days after end of treatment
Number of days with antibiotic-related non-serious adverse events.	From date of treatment initiation until the date of treatment stop for the baseline infection, assessed up to 14 days	Data on diarrhea, loss of appetite, and vomiting will be included.
Proportion of participants with a recurrent infection with a bacterium resistant to the antibiotic given for the baseline infection or an opportunistic infection	Within 100 days after end of treatment

Trial Locations

Locations (4)

Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Copenhagen University Hospital Herlev; 🇩🇰 Herlev, Denmark

Copenhagen University Hospital Hillerød; 🇩🇰 Hillerød, Denmark

Copenhagen University Hospital Hvidovre; 🇩🇰 Hvidovre, Denmark