NCT04244526

Brief 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.
  • 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 25, 2020

Last Update Submit

January 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Three months

Secondary Outcomes (1)

  • Correlation between the virulence genes and antibiotic resistance

    Seven months

Study Arms (3)

Group1

Group 1:pregnant women with cystitis

Other: Talking a urine sample

Group2

Group 2: pregnant women with Pyelonephritis

Other: Talking a urine sample

Group3

Group 3: pregnant women with asymptomatic bacteriuria

Other: Talking a urine sample

Interventions

Just taking a urine sample

Group1Group2Group3

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women at different trimesters with cystitis and pyelonephritis and asymptomatic bacteriuria

You may qualify if:

  • 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

You may not qualify if:

  • pregnant women on antibiotics \_Patients with any anatomical abnormalities in the urinary tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Noura Samir Hussein, Demonstrator

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of medical microbiology and immunology. Faculty of medicine. Assiut university

Study Record Dates

First Submitted

January 25, 2020

First Posted

January 28, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

May 1, 2021

Last Updated

January 30, 2020

Record last verified: 2020-01