Urinary Tract Infections in ChildrenNCT06625554
Urinary Tract Infection In Assiut University Children Hospital
An observational study of Urinary Tract Infections in Children, run by Assiut University.
Trial summary
Antibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection In Assiut University Children Hospital Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Urinary Tract Infections in Children
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Antibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection In Assiut University Children Hospital
Who may be able to join
- 1-Children over 1 month and less than 18 year of age. 2-Diagnosed cases of Urinary Tract Infection. 3-who accepted to participate in the study.
Who cannot join
- 1-neonates and patients more than 18 year. 2-children with chronic kidney diseases. 3-who refused to participate in our study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Antibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection In Assiut University Children Hospital
Antibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection In Assiut University Children Hospital
Read the detailed description
Urinary tract infection is the third most common serious bacterial infection in childhood and has been identified as an important risk factor for the development of progressive renal impairment and longterm consequences.
The epidemiology of UTI during childhood varies by age, gender, circumcision status, and other factors. Boys are more susceptible during the first year of life, mostly in the first 3 months, among boys, uncircumcised infants have an eightfold higher risk; due to phimosis, limiteUrinary tract infection is the third most common serious bacterial infection in childhood and has been identified as an important risk factor for the development of progressive renal impairment and longterm consequences.
The epidemiology of UTI during childhood varies by age, gender, circumcision status, and other factors. Boys are more susceptible during the first year of life, mostly in the first 3 months, among boys, uncircumcised infants have an eightfold higher risk; due to phimosis, limited retraction of the foreskin is significantly associated with an increase in UTIs in male infants, afterward, the incidence is mainly higher in girls, due to differences in anatomy .About 5% of girls and 2% of boys experience at least one incident of UTI up to the age of 7 years.
Symptoms of UTI may be minimal and non-specific in infants and small children. Febrile children not suspected of having UTI are as likely to have UTI as those who are suspected of having UTI. Therefore, diagnosis of UTI can not be made on symptomatology alone and urine examination is advocated in children with minimal suspicion of UTI.
Etiological agents of UTI are variable and usually depend on time, geographical location and age of patients. However, Escherichia coli, Proteus mirabilis, Enterobacter agglomerans, Citrobacter frreundii and Klebsiella pneumonia account for over 70% of cases.
According to sex and age, the incidence and clinical symptoms vary, and the causative organisms are different in pediatric UTI. In addition, as antibiotic-resistant pathogens change and are increased due to the abuse of antibiotics and inappropriate selection, it is necessary to select proper antibiotics in the early phase of treatment. Thus, regular antibiotic sensitivity results from the evaluation of UTI are important to improve the effectiveness of treatment.
The gold standard for the diagnosis of UTI is the detection of the pathogen in urine. The pathogen is detected and identified in urine which contributes to antibacterial treatment. Rapid administrations of empirical antibiotics are required before urine culture testing. Meanwhile, complicated UTI often increase the prevalence of inappropriate antibacterial treatment, which in turn increases antibiotic resistance ABR. In pediatric UTI, ABR is also being raised as a clinical challenge. Therefore, there is an urgent need to identify which bacterial strains in children and explore their susceptibility to commonly used antimicrobials. It could guide effective antibacterial therapy and reduce the multi-drug resistance prevalence in children.
In our study we will collect the age, sex, clinical characteristics for children, microorganism isolation and antimicrobial susceptibility profile in children who had been diagnosed with UTI.
According to sex and age, the incidence and clinical symptoms vary, and the causative organisms are different in pediatric UTI. In addition, as antibiotic-resistant pathogens change and are increased due to the abuse of antibiotics and inappropriate selection, it is necessary to select proper antibiotics in the early phase of treatment. Thus, regular antibiotic sensitivity results from the evaluation of UTI are important to improve the effectiveness of treatment.
The gold standard for the diagnosis of UTI is the detection of the pathogen in urine. The pathogen is detected and identified in urine which contributes to antibacterial treatment. Rapid administrations of empirical antibiotics are required before urine culture testing. Meanwhile, complicated UTI often increase the prevalence of inappropriate antibacterial treatment, which in turn increases antibiotic resistance ABR. In pediatric UTI, ABR is also being raised as a clinical challenge. Therefore, there is an urgent need to identify which bacterial strains in children and explore their susceptibility to commonly used antimicrobials. It could guide effective antibacterial therapy and reduce the multi-drug resistance prevalence in children.
In our study we will collect the age, sex, clinical characteristics for children, microorganism isolation and antimicrobial susceptibility profile in children who had been diagnosed with UTI.
- Conditions
- Urinary Tract Infections in Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample size
75 patient
The sample size was calculated using Epi-info version 7 software, based on the following assumptions:
Main outcome variable is to assess Antibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection in Children of Assiut University Hospital Based on previous studies (7) the prevalence of antibiotic resistance in children with UTI was 13%, and based on the percentage confidence limits of 5% and a Confidence level=80%
Measured: Baseline
Investigations
1_urine analysis 2- complete blood count(CBC) 3- urine culture and sensitivity
Measured: Baseline
History
- fever
- burning micturation
- dysuria
- urgency
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infections in ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed fathy Mohamed farag, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625554
- Sponsor's protocol ID
- UTI in children
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rai GK, Upreti HC, Rai SK, Shah KP, Shrestha RM. Causative agents of urinary tract infections in children and their antibiotic sensitivity pattern: a hospital based study. Nepal Med Coll J. 2008 Jun;10(2):86-90.
PubMed 18828428Fenta A, Dagnew M, Eshetie S, Belachew T. Bacterial profile, antibiotic susceptibility pattern and associated risk factors of urinary tract infection among clinically suspected children attending at Felege-Hiwot comprehensive and specialized hospital, Northwest Ethiopia. A prospective study. BMC Infect Dis. 2020 Sep 16;20(1):673. doi: 10.1186/s12879-020-05402-y.
PubMed 32938424Antibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection among Hospitalized Children. Saudi J Biomed Res, 7(12): 332-338.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection In Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT06625554
- Acronym / sponsor ID
- UTI in children
- Conditions
- Urinary Tract Infections in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection In Assiut University Children Hospital
Detailed description
Urinary tract infection is the third most common serious bacterial infection in childhood and has been identified as an important risk factor for the development of progressive renal impairment and longterm consequences.
The epidemiology of UTI during childhood varies by age, gender, circumcision status, and other factors. Boys are more susceptible during the first year of life, mostly in the first 3 months, among boys, uncircumcised infants have an eightfold higher risk; due to phimosis, limiteUrinary tract infection is the third most common serious bacterial infection in childhood and has been identified as an important risk factor for the development of progressive renal impairment and longterm consequences.
The epidemiology of UTI during childhood varies by age, gender, circumcision status, and other factors. Boys are more susceptible during the first year of life, mostly in the first 3 months, among boys, uncircumcised infants have an eightfold higher risk; due to phimosis, limited retraction of the foreskin is significantly associated with an increase in UTIs in male infants, afterward, the incidence is mainly higher in girls, due to differences in anatomy .About 5% of girls and 2% of boys experience at least one incident of UTI up to the age of 7 years.
Symptoms of UTI may be minimal and non-specific in infants and small children. Febrile children not suspected of having UTI are as likely to have UTI as those who are suspected of having UTI. Therefore, diagnosis of UTI can not be made on symptomatology alone and urine examination is advocated in children with minimal suspicion of UTI.
Etiological agents of UTI are variable and usually depend on time, geographical location and age of patients. However, Escherichia coli, Proteus mirabilis, Enterobacter agglomerans, Citrobacter frreundii and Klebsiella pneumonia account for over 70% of cases.
According to sex and age, the incidence and clinical symptoms vary, and the causative organisms are different in pediatric UTI. In addition, as antibiotic-resistant pathogens change and are increased due to the abuse of antibiotics and inappropriate selection, it is necessary to select proper antibiotics in the early phase of treatment. Thus, regular antibiotic sensitivity results from the evaluation of UTI are important to improve the effectiveness of treatment.
The gold standard for the diagnosis of UTI is the detection of the pathogen in urine. The pathogen is detected and identified in urine which contributes to antibacterial treatment. Rapid administrations of empirical antibiotics are required before urine culture testing. Meanwhile, complicated UTI often increase the prevalence of inappropriate antibacterial treatment, which in turn increases antibiotic resistance ABR. In pediatric UTI, ABR is also being raised as a clinical challenge. Therefore, there is an urgent need to identify which bacterial strains in children and explore their susceptibility to commonly used antimicrobials. It could guide effective antibacterial therapy and reduce the multi-drug resistance prevalence in children.
In our study we will collect the age, sex, clinical characteristics for children, microorganism isolation and antimicrobial susceptibility profile in children who had been diagnosed with UTI.
According to sex and age, the incidence and clinical symptoms vary, and the causative organisms are different in pediatric UTI. In addition, as antibiotic-resistant pathogens change and are increased due to the abuse of antibiotics and inappropriate selection, it is necessary to select proper antibiotics in the early phase of treatment. Thus, regular antibiotic sensitivity results from the evaluation of UTI are important to improve the effectiveness of treatment.
The gold standard for the diagnosis of UTI is the detection of the pathogen in urine. The pathogen is detected and identified in urine which contributes to antibacterial treatment. Rapid administrations of empirical antibiotics are required before urine culture testing. Meanwhile, complicated UTI often increase the prevalence of inappropriate antibacterial treatment, which in turn increases antibiotic resistance ABR. In pediatric UTI, ABR is also being raised as a clinical challenge. Therefore, there is an urgent need to identify which bacterial strains in children and explore their susceptibility to commonly used antimicrobials. It could guide effective antibacterial therapy and reduce the multi-drug resistance prevalence in children.
In our study we will collect the age, sex, clinical characteristics for children, microorganism isolation and antimicrobial susceptibility profile in children who had been diagnosed with UTI.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Antibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection In Assiut University Children Hospital
Key inclusion criteria (1 listed)
- 1-Children over 1 month and less than 18 year of age. 2-Diagnosed cases of Urinary Tract Infection. 3-who accepted to participate in the study.
Key exclusion criteria (1 listed)
- 1-neonates and patients more than 18 year. 2-children with chronic kidney diseases. 3-who refused to participate in our study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sample size
Time frame: Baseline
75 patient The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is to assess Antibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection in Children of Assiut University Hospital Based on previous studies (7) the prevalence of antibiotic resistance in children with UTI was 13%, and based on the percentage confidence limits of 5% and a Confidence level=80%
Investigations
Time frame: Baseline
1_urine analysis 2- complete blood count(CBC) 3- urine culture and sensitivity
History
Time frame: Baseline
1. fever 2. burning micturation 3. dysuria 4. urgency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Results publication: PubMed 18828428Rai GK, Upreti HC, Rai SK, Shah KP, Shrestha RM. Causative agents of urinary tract infections in children and their antibiotic sensitivity pattern: a hospital based study. Nepal Med Coll J. 2008 Jun;10(2):86-90.
- Results publication: PubMed 32938424Fenta A, Dagnew M, Eshetie S, Belachew T. Bacterial profile, antibiotic susceptibility pattern and associated risk factors of urinary tract infection among clinically suspected children attending at Felege-Hiwot comprehensive and specialized hospital, Northwest Ethiopia. A prospective study. BMC Infect Dis. 2020 Sep 16;20(1):673. doi: 10.1186/s12879-020-05402-y.
- Results publicationAntibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection among Hospitalized Children. Saudi J Biomed Res, 7(12): 332-338.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections in Children, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed fathy mohamed (01220845738, Ahmedfathyelnagar123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sample size (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06625554, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.