Antibiograms of Intensive Care Units at an Egyptian Tertiary Care Hospital

NCT04318613 | Completed

• 1 other identifier: 5944-5-3-2020
• Study Type: observational
• Target: 45,221
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (3)

• Prevalence of micro-organisms at an Egyptian Tertiary Care Hospital

  the prevalence and types of micro-organisms in Zagazig University Hospitals' ICUs by using data record base.

  one year

• generation of ICU specific antibiogram

  prepare and interprete antibiograms to guide empirical antibiotics prescription at ICUs of zagazig university hospitals by data record base cross sectional study

  one year

• the incidence of antibiotic susceptibility and resistance pattern of these micro-organisms

  the incidence of each antibiotic susceptibility and resistance pattern of micro-organisms at Zagazig University Hospitals' ICUs by record base study.

  one year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Emergency, Surgical Intensive Care Units,medical, pulmonary, coronary, neonatal, and pediatric ICUs-Zagazig University Hospitals

Zagazig, Sharqia Province, 44111, Egypt

Location

Related Publications (11)

• Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.

  PMID: 19952319 BACKGROUND

• van Hauwermeiren E, Iosifidis E, Karki T, Suetens C, Kinross P, Plachouras D. Development of case vignettes for assessment of the inter-rater variability of national validation teams for the point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals. J Hosp Infect. 2019 Apr;101(4):455-460. doi: 10.1016/j.jhin.2019.01.018. Epub 2019 Jan 23.

  PMID: 30682398 BACKGROUND

• Law T, Chibabhai V, Nana T. Analysis and comparison of cumulative antibiograms for the Charlotte Maxeke Johannesburg Academic Hospital adult intensive care and high-care units, 2013 and 2017. S Afr Med J. 2019 Dec 12;110(1):55-64. doi: 10.7196/SAMJ.2019.v110i1.13841.

  PMID: 31865944 BACKGROUND

• Vincent JL, Bassetti M, Francois B, Karam G, Chastre J, Torres A, Roberts JA, Taccone FS, Rello J, Calandra T, De Backer D, Welte T, Antonelli M. Advances in antibiotic therapy in the critically ill. Crit Care. 2016 May 17;20(1):133. doi: 10.1186/s13054-016-1285-6.

  PMID: 27184564 BACKGROUND

• Campion M, Scully G. Antibiotic Use in the Intensive Care Unit: Optimization and De-Escalation. J Intensive Care Med. 2018 Dec;33(12):647-655. doi: 10.1177/0885066618762747. Epub 2018 Mar 13.

  PMID: 29534630 BACKGROUND

• Brusselaers N, Vogelaers D, Blot S. The rising problem of antimicrobial resistance in the intensive care unit. Ann Intensive Care. 2011 Nov 23;1:47. doi: 10.1186/2110-5820-1-47.

  PMID: 22112929 BACKGROUND

• Hughes MA, Dosa DM, Caffrey AR, Appaneal HJ, Jump RLP, Lopes V, LaPlante KL. Antibiograms Cannot Be Used Interchangeably Between Acute Care Medical Centers and Affiliated Nursing Homes. J Am Med Dir Assoc. 2020 Jan;21(1):72-77. doi: 10.1016/j.jamda.2019.07.016. Epub 2019 Sep 16.

  PMID: 31537479 BACKGROUND

• Kollef MH, Bassetti M, Francois B, Burnham J, Dimopoulos G, Garnacho-Montero J, Lipman J, Luyt CE, Nicolau DP, Postma MJ, Torres A, Welte T, Wunderink RG. The intensive care medicine research agenda on multidrug-resistant bacteria, antibiotics, and stewardship. Intensive Care Med. 2017 Sep;43(9):1187-1197. doi: 10.1007/s00134-017-4682-7. Epub 2017 Feb 4.

  PMID: 28160023 BACKGROUND

• Cheesbrough M. District laboratory practice in tropical countries part II. 2. NewYork: Cambridge University Press; 2006.

  BACKGROUND

• 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.

  BACKGROUND

• Magiorakos AP, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, Harbarth S, Hindler JF, Kahlmeter G, Olsson-Liljequist B, Paterson DL, Rice LB, Stelling J, Struelens MJ, Vatopoulos A, Weber JT, Monnet DL. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect. 2012 Mar;18(3):268-81. doi: 10.1111/j.1469-0691.2011.03570.x. Epub 2011 Jul 27.

  PMID: 21793988 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sherif M Mowafy, MD

  Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University

  PRINCIPAL INVESTIGATOR

• Essamedin M Negm, MD

  Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 24, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

EG (1)