RECRUITINGOBSERVATIONAL
Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection
Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Suspected or Confirmed Uncomplicated Urinary Tract Infection. A Single-arm Multicenter Prospective Observational Study.
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Clinical suspicion of urinary tract infection irrespective of the presence of fever.
2. Clinically stable (i.e., not respiratory or circulatory affected, septic, or meningeal).
3. 4 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.
Who Should NOT Join This Trial:
1. Non-Danish civil registration number.
2. High-risk medical history.
1. Previous urinary tract infection.
2. Prophylactic antibiotic treatment.
3. 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).
4. Previous hospitalization needing antibiotic therapy.
3. Markedly elevated c-reactive protein indicating bacteremia.
4. Elevated creatinine.
5. Oral therapy is not possible (e.g., frequent vomiting or excessive regurgitation).
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
INCLUSION CRITERIA:
1. Clinical suspicion of urinary tract infection irrespective of the presence of fever.
2. Clinically stable (i.e., not respiratory or circulatory affected, septic, or meningeal).
3. 4 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.
EXCLUSION CRITERIA:
1. Non-Danish civil registration number.
2. High-risk medical history.
1. Previous urinary tract infection.
2. Prophylactic antibiotic treatment.
3. 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).
4. Previous hospitalization needing antibiotic therapy.
3. Markedly elevated c-reactive protein indicating bacteremia.
4. Elevated creatinine.
5. Oral therapy is not possible (e.g., frequent vomiting or excessive regurgitation).
Treatments Being Tested
DRUG
Oral antibiotic therapy
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.
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