Nosocomial Bacterial and Fungal Chest Infections in Cirrh... | NCT03413293

Studies
Nosocomial Bacterial and Fungal Chest Infections in Cirrhotic Patients

NCT03413293

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

May 18, 2018Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Nosocomial Infection

Interventions

Diagnosis of bacterial infections

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

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

Feb 2018

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

Jun 2018Estimated

Primary Completion Date

May 2019Estimated

Completion Date

Aug 2019Estimated

First Submitted Date

Jan 8, 2018

First Submission Date that Met QC Criteria

Jan 22, 2018

First Posted Date

Jan 29, 2018Actual

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

May 16, 2018

Last Update Posted Date

May 18, 2018Actual

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

Hospital acquired chest Infections are common complications in hospitalized cirrhotic patients. Infectious complications are the most common cause of mortality in cirrhotic patients with bronchopneumonia early antibiotic treatment at the base of culture and sensitivity is an optimal therapeutic approach in cirrhotics with nosocomial pneumonia Intensive care unit acquired pneumonia is the leading infection in critically ill patients and a major cause of morbidity and mortality despite recent major advances in antimicrobial therapy, supportive care, and the use of a broad range of preventive measures

Detailed Description

Aim of the work

To estimate the frequency and risk factors of nosocomial chest infections in cirrhotic patients .
To determine the causative pathogens of nosocomial chest infections in patients with cirrhosis including fungal infections in order to establish our local empirical antimicrobial protocol.
To define the impact of nosocomial chest infections on survival of our patients.
To develop an effective and continuous surveillance program and infection control measures to reduce the burden of these infections as well as morbidity , mortality , hospital stay ,hospital cost and to achieve quality of care .
To motivate pharmaceutical companies to create a new umbrella coverage of antimicrobials through the ongoing knowledge of the changes in microbial resistance pattern inside hospitals

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nosocomial infected cirrhotic patients			Diagnostic Test: Diagnosis of bacterial infections

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnosis of bacterial infections	Diagnostic Test	Cultures	Nosocomial infected cirrhotic patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of nosocomial infection in patients with liver cirrhosis	nosocomial infection is one of predictors of bad outcome in liver cirrhosis	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All cirrhotic patients , decompensated , child pug score B or C ,may have Hepatocellular carcinoma , other comorbidities may present as (Diabetius mellitus , Hypertension , Heart disease and renal impairment ) , both sex and with clinical suspicion of chest infections acquired after 48 hours of admission

Exclusion Criteria:

Patients have any chronic chest disease
Patients have severe immunosuppression (neutropenia after chemotherapy or hematopoietic transplant, drug-induced immunosuppression in solid-organ transplant or cytotoxic therapy, and HIV-related disorders.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patient were known to have liver cirrhois and admitted at hospital secondary to any cause

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nariman zaghluol bakhiet, postgraduate	Contact	01005546130		narimandoctor@yahoo.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23907496	Background	Di Pasquale M, Esperatti M, Crisafulli E, Ferrer M, Bassi GL, Rinaudo M, Escorsell A, Fernandez J, Mas A, Blasi F, Torres A. Impact of chronic liver disease in intensive care unit acquired pneumonia: a prospective study. Intensive Care Med. 2013 Oct;39(10):1776-84. doi: 10.1007/s00134-013-3025-6. Epub 2013 Aug 2.

ID	Term
D007239	Infections
D007049	Iatrogenic Disease
D020969	Disease Attributes
D010335	Pathologic Processes