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

NCT05819229 | Recruiting DMC

• 1 other identifier: PO AB UTI
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 4

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.

Conditions

Urinary Tract Infections in Children

Keywords

Antibiotic therapy; Urinary tract infection; Children

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with recurrent urinary tract infection regardless of the pathogen or death of any cause

  Within 28 days after end of treatment

• Number of days admitted related to urinary tract symptoms

  Within 28 days after treatment initiation

Secondary Outcomes (3)

• 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

• 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

• 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

Other Outcomes (1)

• Proportion of participants with a serious adverse event.

  Within 100 days after treatment initiation

Study Arms (1)

Oral antibiotic therapy

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

Drug: Oral antibiotic therapy

Interventions

Oral antibiotic therapy DRUG

Empirical choice: amoxicillin-clavulanic acid 50 mg/kg/day divided into three doses. If the sensitivity pattern is available, another oral antibiotic, preferably smaller-spectrum, can be used instead. Total duration of antibiotic therapy will be 10 days.

Oral antibiotic therapy

Eligibility Criteria

• Age: 4 Weeks - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children aged 4 weeks to 2 months who are referred by their primary physician or the medical helpline 1813 (outside the work hours of their primary physician) to one of four pediatric emergency departments in the Capital Region of Denmark with suspected urinary tract infection.

You may qualify if:

• Clinical suspicion of urinary tract infection irrespective of the presence of fever.
• Clinically stable (i.e., not respiratory or circulatory affected, septic, or meningeal).
• weeks to 2 months of age (corrected age, if premature).
• All children who do not receive any empirical antibiotic therapy but have a positive urine culture can be included if the clinical suspicion of urinary tract infection persists.
• A positive urine culture is defined as:
• Suprapubic bladder aspiration: any growth of bacteria.
• Sterile intermittent catheterization: monoculture with ≥10\^3 colony forming units per milliliter (cfu/ml).
• Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10\^4 cfu/ml.
• Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10\^5 cfu/ml in one test and 10\^3 cfu/ml in another test.

You may not qualify if:

• Non-Danish civil registration number.
• High-risk medical history.
• Previous urinary tract infection.
• Prophylactic antibiotic treatment.
• Known urogenital abnormality (i.e., hydronephrosis (pyelectasis ≥10 mm or/and caliectasis ≥5 mm); hydroureter; vesicoureteral reflux; multicystic dysplasia; renal dysplasia; renal hypoplasia; renal agenesis; duplex kidney; ectopic placed kidneys; polycystic kidney disease; neurogenic bladder dysfunction; and hypospadias).
• Previous hospitalization needing antibiotic therapy.
• Markedly elevated c-reactive protein indicating bacteremia.
• Elevated creatinine.
• Oral therapy is not possible (e.g., frequent vomiting or excessive regurgitation).

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Hvidovre University Hospital: collaborator

Study Sites (4)

Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Copenhagen University Hospital Herlev

Herlev, 2730, Denmark

RECRUITING

Copenhagen University Hospital Hillerød

Hillerød, 3400, Denmark

RECRUITING

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Anti-Infective Agents

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Naqash Sethi, MD

  Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Ulrikka Nygaard, Ass. prof, Ph.D.

  Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark

  STUDY CHAIR

Central Study Contacts

Naqash Sethi, MD

CONTACT

+4528405083; naqash.javaid.sethi.02@regionh.dk

Ulrikka Nygaard, Ass. prof, Ph.D.

CONTACT

+4535459761; ulrikka.nygaard@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: April 19, 2023
• Study Start: February 27, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Primarily for the conduction of research or quality improvement projects.

Locations

DK (4)