Urinary Tract InfectionsNCT04244526
Urinary Tract Infection in Pregnancy
An observational study of Urinary Tract Infections, run by Assiut University.
Trial summary
to describe the profile of uropathogenic E coli from Egyptian pregnant women with UTIs and a symptomatic bacteriuria. to determine the susceptibility pattern of our local isolated UPEC strains which is essential for optimal management of UTI. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Talking a urine sample
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 May 2021
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women at different trimesters with cystitis and pyelonephritis and asymptomatic bacteriuria
Who may be able to join
- pregnant women who diagnosed through clinical examination and urine analysis. 3 groups : group 1 pregnant women with cystitis Group 2 pregnant women with Pyelonephritis Group 3 pregnant women with asymptomatic bacteriuria
Who cannot join
- pregnant women on antibiotics _Patients with any anatomical abnormalities in the urinary tract
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Distribution of Virulence Genes and Their Association With Clinical Presentation of Urinary Tract Infection and Antimicrobial Resistance Among Uropathogenic Escherichia Coli Isolated From Pregnant Women
- to describe the profile of uropathogenic E coli from Egyptian pregnant women with UTIs and a symptomatic bacteriuria.
- to determine the susceptibility pattern of our local isolated UPEC strains which is essential for optimal management of UTI.
- to evaluate the different virulence genes in UPEC isolates and their association with antibiotic resistance.
- to track common UPEC serogroups.
- to investigate the biofilm formation and the relationship between virulence genes and biofilm formation in UPEC strains isolated from patients.
Read the detailed description
Urinary tract infection represents the most common bacterial infection in pregnancy and the third common cause of human infection after respiratory and intestinal infections. The infection can be life threatening and associated with serious complications. UTI can be associated with defined symptoms'symptomatic' or without symptoms 'asymptomatic'. Asymptomatic bacteriuria is defined as the presence of >100000 colony forming units/ml of urine of a single pathogen in two consecutive midstream clean catch urine specimen or on catheterization specimen from an individual without signs or symptoms associated with urinary or genital organs. Asymptomatic bacteriuria can lead to acute pyelonephritis in30%of pregnant women and complications such as early delivery, increase risk of hypertension, pre-eclampsia, low birth weight and postpartum endometritis. Ecoli accounts for most cases of symptomatic and asymptomatic bacteriuria in women, representing70 _90 %of the cases. The important virulence factors of uropathogenic ecoli can be broadly divided into two groups :bacterial cell surface factors and secreted factors. The emergence of drug resistant microorganism among Uropathogenic Escherichia coli strains increases the serious threat to global health. Ecoli often acquired genes coding for antibiotic resistance, beta-lactamase enzymes are the most frequent and play a key role, conferring resistance of bacteria to beta lactam antibiotic group such as penicillin and cephalosporins. Therefore, knowledge regarding local prevalence of uropathogenic ecoli and antimicrobial resistance is essential for optimal management of UTI.
- Conditions
- Urinary Tract Infections
- Being tested
- Talking a urine sample
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talking a urine sampleOther
Just taking a urine sample
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Group 1:pregnant women with cystitis Receives: Other: Talking a urine sample | |
| Group2 | Group 2: pregnant women with Pyelonephritis Receives: Other: Talking a urine sample | |
| Group3 | Group 3: pregnant women with asymptomatic bacteriuria Receives: Other: Talking a urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of virulence genes in different isolated UPEC strains
Measurment of virulence genes of Escherichia coli strains by molecular diagnosis as PCR technique to determine relationship between clinical presentation of urinary tract infection and distribution of virulence genes of strains
Measured: Three months
Secondary outcomes (1)
Correlation between the virulence genes and antibiotic resistance
Measurment of virulence genes of escherichia coli strains by molecular diagnosis as PCR technique,and determine antibiotic susceptibility of ecoli strains between different groups of women to determine relationship between distribution of virulence genea and antibiotic susceptibility of strains
Measured: Seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NSHussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244526
- Sponsor's protocol ID
- Urinary tract infection
- Status last verified
- Jan 2020
- First submitted
- 25 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Virulence Genes and Their Association With Clinical Presentation of Urinary Tract Infection and Antimicrobial Resistance Among Uropathogenic Escherichia Coli Isolated From Pregnant Women
- ClinicalTrials.gov ID
- NCT04244526
- Acronym / sponsor ID
- Urinary tract infection
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 28 Jan 2020 (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.
- to describe the profile of uropathogenic E coli from Egyptian pregnant women with UTIs and a symptomatic bacteriuria.
- to determine the susceptibility pattern of our local isolated UPEC strains which is essential for optimal management of UTI.
- to evaluate the different virulence genes in UPEC isolates and their association with antibiotic resistance.
- to track common UPEC serogroups.
- to investigate the biofilm formation and the relationship between virulence genes and biofilm formation in UPEC strains isolated from patients.
Detailed description
Urinary tract infection represents the most common bacterial infection in pregnancy and the third common cause of human infection after respiratory and intestinal infections. The infection can be life threatening and associated with serious complications. UTI can be associated with defined symptoms'symptomatic' or without symptoms 'asymptomatic'. Asymptomatic bacteriuria is defined as the presence of >100000 colony forming units/ml of urine of a single pathogen in two consecutive midstream clean catch urine specimen or on catheterization specimen from an individual without signs or symptoms associated with urinary or genital organs. Asymptomatic bacteriuria can lead to acute pyelonephritis in30%of pregnant women and complications such as early delivery, increase risk of hypertension, pre-eclampsia, low birth weight and postpartum endometritis. Ecoli accounts for most cases of symptomatic and asymptomatic bacteriuria in women, representing70 _90 %of the cases. The important virulence factors of uropathogenic ecoli can be broadly divided into two groups :bacterial cell surface factors and secreted factors. The emergence of drug resistant microorganism among Uropathogenic Escherichia coli strains increases the serious threat to global health. Ecoli often acquired genes coding for antibiotic resistance, beta-lactamase enzymes are the most frequent and play a key role, conferring resistance of bacteria to beta lactam antibiotic group such as penicillin and cephalosporins. Therefore, knowledge regarding local prevalence of uropathogenic ecoli and antimicrobial resistance is essential for optimal management of UTI.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Other: Talking a urine sampleGroup 1:pregnant women with cystitis |
| Group2 | – | Other: Talking a urine sampleGroup 2: pregnant women with Pyelonephritis |
| Group3 | – | Other: Talking a urine sampleGroup 3: pregnant women with asymptomatic bacteriuria |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women at different trimesters with cystitis and pyelonephritis and asymptomatic bacteriuria
Key inclusion criteria (1 listed)
- pregnant women who diagnosed through clinical examination and urine analysis. 3 groups : group 1 pregnant women with cystitis Group 2 pregnant women with Pyelonephritis Group 3 pregnant women with asymptomatic bacteriuria
Key exclusion criteria (1 listed)
- pregnant women on antibiotics _Patients with any anatomical abnormalities in the urinary tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talking a urine sampleJust taking a urine sample | Other | Group1, Group2, Group3 |
Primary outcome
The percentage of virulence genes in different isolated UPEC strains
Time frame: Three months
Measurment of virulence genes of Escherichia coli strains by molecular diagnosis as PCR technique to determine relationship between clinical presentation of urinary tract infection and distribution of virulence genes of strains
1 secondary outcome
Correlation between the virulence genes and antibiotic resistance
Time frame: Seven months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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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, 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 30 Jan 2020. 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 Noura Samir Hussein, Demonstrator (00201002606302, Noura011456@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of virulence genes in different isolated UPEC strains (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2020.