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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04318613
Other study ID # 5944-5-3-2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2019

Study information

Verified date June 2020
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 45221
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Emergency, Surgical Intensive Care Units,medical, pulmonary, coronary, neonatal, and pediatric ICUs-Zagazig University Hospitals Zagazig Sharkia

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

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. — View Citation

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. Review. — View Citation

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.

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

van Hauwermeiren E, Iosifidis E, Kärki 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. — View Citation

Vincent JL, Bassetti M, François 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. Review. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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