Phenotypic and Genotypic Characterization of Escherichia... | NCT06462261

Studies
Phenotypic and Genotypic Characterization of Escherichia Coli

NCT06462261

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jun 17, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Antibiotic Sensitivity Testing and Genotypic Caharacterization of Ecoli

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Estimated

Primary Completion Date

Nov 2024Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Jun 9, 2024

First Submission Date that Met QC Criteria

Jun 12, 2024

First Posted Date

Jun 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2024

Last Update Posted Date

Jun 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Collection of urine samples Cultivation Antibiotic sensitivity test PCR

Detailed Description

Cultivation on MaCconkey and EMB IMVC test Dis diffusion test Detection of virulence and antibiotic resistance genes by PCR

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Group 1		Escherichia coli isolates

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antibiotic sensitivity testing whether sensitive .intermediately sensitive and resistance		6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Catheter associated urinary tract infections in patient with catheter more than two 2 days .fever.urine culture with no more than 2 species organisation catheterization .fever.suprapubic tenderness with urine culture more than 105 CFU/Ml

Exclusion Criteria:

asymptomatic bacteriuria UTI before 48 hrs

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adults only with hospital acquired infections

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Mar 18, 2025
Reset	Apr 7, 2025