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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Ghada Omar Elsedfy contact

01111985154

gelsedfy@aun.edu.eg

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Investigations

    1_urine analysis 2- complete blood count(CBC) 3- urine culture and sensitivity

    Measured: Baseline

  3. History

    1. fever
    2. burning micturation
    3. dysuria
    4. urgency

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2024
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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)
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 18828428
  • Fenta 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 32938424
  • Antibiotic Sensitivity Pattern and Demographic Characteristics of Urinary Tract Infection among Hospitalized Children. Saudi J Biomed Res, 7(12): 332-338.

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.

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