Predictors of Antimicrobial Resistance in the Respiratory... | NCT06750744

Studies
Predictors of Antimicrobial Resistance in the Respiratory Intensive Care Unit of Alexandria Main University Hospital

NCT06750744

Sponsor

Mohamed Sabry

Status

Completed

Last Update Posted

Dec 27, 2024Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Identify the Predictors of Antibiotic Resistance

Interventions

chest x ray
chest X ray
Tigecycline (Tygacil)

Countries

Egypt

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Actual

Primary Completion Date

Dec 11, 2024Actual

Completion Date

Dec 12, 2024Actual

First Submitted Date

Dec 20, 2024

First Submission Date that Met QC Criteria

Dec 24, 2024

First Posted Date

Dec 27, 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

Dec 24, 2024

Last Update Posted Date

Dec 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to identify the predictors of antibiotic resistance whether clinical or laboratory or radiological or all

Detailed Description

The goal of this clinical trial is to identify the predictors of antibiotic resistance like the history of previous antibiotic ,the antibiogram of the centre , comorbidities,..etc to decide the suitable antibiotic

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

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
only one group of patients		to identify the predictors of antibiotic resistance using rates of resistance,comprehensive data of each patient chest X ray,CT,ultrasound	Radiation: chest x ray Drug: Tigecycline (Tygacil)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
chest x ray	Radiation	chest X ray identify severity of pneumonia	only one group of patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
antibiogram	resistance rates in antibiograms	3 months

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
resistance rates in the antibiogram	culture and different antibiotic senstivity	3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient admitted to the respiratory ICU due to bacterial infection.
- Recent antibiotic intake in the past three months.
- Intercostal tube insertion for empyema.
- Shocked patients with inserted central venous catheter.
- Intubated or tracheostomized patients.
- Patients with grade two to four bed sores.

Exclusion Criteria:

. Inability to provide written informed consent for the study.
- Non sterile sample collection technique.
- Inability to provide antibiogram.
- Isolated patients due to suspected tuberculosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The current study aims to identify the predictors of antibiotic resistance in the respiratory intensive care unit of Alexandria main university hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
mohamed sabry eltarhony, lecturer	Alexandria University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chest Department -Faculty of Medicine		Alexandria	Azarita	11511	Egypt

Label	URL
antimicrobial resistancde prediction	View source

ID	Type	URL	Comment
msabry776@yahoo.com	Study Protocol	View IPD

IPD Sharing Statement Module

Plan to Share IPD

Description

because the facility, where i do my work, refuse to share any project untill it is fully published

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014965	X-Rays
D008826	Microbial Sensitivity Tests
D000078304	Tigecycline

Ancestor Terms

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided