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Antibiograms of Intensive Care Units at an Egyptian Tertiary Care Hospital

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318613
Recruitment Status : Completed
First Posted : March 24, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Sherif M. S. Mowafy, Zagazig University

Brief Summary:
The burden of antimicrobial resistance is high in ICUs and antibiotic therapy must continue to be used to improve health and save lives. However, the overuse or inappropriate use of antibiotics across the spectrum of healthcare and in the community is a leading cause of preventable antibiotic resistance development. Several achievements in medicine depend on effective antibiotic therapy and we need to preserve antibiotics to protect future generations. ICU physicians should have regularly updated antibiograms in order to guide appropriate decisions about the choice of empirical antibiotics when waiting for culture results. The appropriate selection of empirical antibiotic therapy should be guided by ICU-specific antibiogram.

Condition or disease
Critical Illness

Detailed Description:

Hospital Acquired Infections (HAIs) surveillance at the local and national levels is an essential component of its control and prevention. The highest prevalence of HAIs is in Intensive care units (ICUs) and it is associated with considerable negative impact on the patients' outcome with a marked increase in the treatment costs. Therefore, early appropriate antibiotic therapy is a fundamental part of the treatment of these patients and it can be lifesaving. However, bacteria are becoming more resistant with alarming rates of antibiotic resistance worldwide.

Antibiotic resistance is part of a broader threat called antimicrobial resistance (AMR) that includes resistance to medicines used to treat all types of infections, including those caused by bacteria, parasites, and fungi. ICUs are considered the epicenter of AMR development due to the severity of critical illness, patients are at high risk of becoming infected through the use of invasive devices (e.g. endotracheal tubes, vascular and urinary catheters), and the extensive antibiotic use with variable infection control practices. Consequently, management of infections in ICU is a growing challenge and ICU physicians should have regularly updated antibiograms in order to guide appropriate decisions about the choice of empirical antibiotics when waiting for culture results Antibiograms are reports that summarize the information of bacterial antibiotic susceptibility rates within a single facility over the duration of one calendar year. They are used in tracking bacterial resistance and guiding empirical antibiotics prescription within the facility.

With the high burden of AMR and the ample variety between ICUs in the prevalence of micro-organisms and their antibiotic susceptibility, it is crucial that the selection of empirical antibiotic therapy should be guided by ICU-specific antibiogram. Also, the emerging trends in bacterial resistance at the local level should be monitored regularly.

The aim of this study is to find out the prevalence and types of pathogens and to determine their antibiotic susceptibility and resistance in different ICUs of an Egyptian tertiary care hospital (Zagazig University Hospitals).

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Study Type : Observational [Patient Registry]
Actual Enrollment : 45221 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 10 Days
Official Title: Antibiograms of Intensive Care Units at an Egyptian Tertiary Care Hospital
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Prevalence of micro-organisms at an Egyptian Tertiary Care Hospital [ Time Frame: one year ]
    the prevalence and types of micro-organisms in Zagazig University Hospitals' ICUs by using data record base.

  2. generation of ICU specific antibiogram [ Time Frame: one year ]
    prepare and interprete antibiograms to guide empirical antibiotics prescription at ICUs of zagazig university hospitals by data record base cross sectional study

  3. the incidence of antibiotic susceptibility and resistance pattern of these micro-organisms [ Time Frame: one year ]
    the incidence of each antibiotic susceptibility and resistance pattern of micro-organisms at Zagazig University Hospitals' ICUs by record base study.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Data was collected from all routine bacterial cultures in Zagazig University Hospitals' ICUs (emergency, surgical, medical, pulmonary, coronary, neonatal, and pediatric ICUs) over a one-year period from 1 /1/ 2019 to 31/12/ 2019.
Criteria

Inclusion Criteria:

  • First isolate culture /patient .
  • Only species with ≽ 30 isolates
  • Diagnostic isolates
  • Verified final results
  • Routinely tested antimicrobial agents

Exclusion Criteria:

  • Duplicate bacterial isolates
  • Surveillance culture and screening isolates
  • Reported Intermediate sensitivity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318613


Locations
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Egypt
Emergency, Surgical Intensive Care Units,medical, pulmonary, coronary, neonatal, and pediatric ICUs-Zagazig University Hospitals
Zagazig, Sharkia, Egypt, 44111
Sponsors and Collaborators
Zagazig University
Investigators
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Principal Investigator: Sherif M Mowafy, MD Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
Study Director: Essamedin M Negm, MD Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
Principal Investigator: Ahmad A Mohammed, MD Clinical Pathology Department, Faculty of Medicine, Zagazig University
Principal Investigator: Tarek H Hassan, MD Chest Department, Faculty of Medicine, Zagazig University
Principal Investigator: Marwa G Amer, Master Clinical Pathology Department, Faculty of Medicine, Zagazig University
Principal Investigator: Ahmed E Tawfik, Bachelor Clinical pharmacist, Zagazig University Hospitals
Publications:
Cheesbrough M. District laboratory practice in tropical countries part II. 2. NewYork: Cambridge University Press; 2006.
Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; 26th Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2016. CLSI document M100-S26.

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Responsible Party: Sherif M. S. Mowafy, Lecturer of anesthesia and surgical intensive care, Zagazig University
ClinicalTrials.gov Identifier: NCT04318613    
Other Study ID Numbers: 5944-5-3-2020
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all individual participant data that underlie results in the publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: the individual participant data and any additional supporting information will become available starting 6 months after publication.
Access Criteria: by contacting the study director

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes