- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413293
Nosocomial Bacterial and Fungal Chest Infections in Cirrhotic Patients
May 16, 2018 updated by: NZBakhiet, Assiut University
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patient were known to have liver cirrhois and admitted at hospital secondary to any cause
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Nosocomial infected cirrhotic patients
|
Cultures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of nosocomial infection in patients with liver cirrhosis
Time Frame: baseline
|
nosocomial infection is one of predictors of bad outcome in liver cirrhosis
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2018
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
August 1, 2019
Study Registration Dates
First Submitted
January 8, 2018
First Submitted That Met QC Criteria
January 22, 2018
First Posted (Actual)
January 29, 2018
Study Record Updates
Last Update Posted (Actual)
May 18, 2018
Last Update Submitted That Met QC Criteria
May 16, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBFCIIHCP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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