Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05819229
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-02-22
Brief Title:
Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgkgday 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 mgkg once daily and ampicillin 100 mgkgday 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
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 mgkgday 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 mgkg once daily and ampicillin 100 mgkgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None