Clinical trial NCT04318613: Antibiograms of Intensive Care Units at an Egyptian Tertiary Care Hospital
Official title: Antibiograms of Intensive Care Units at an Egyptian Tertiary Care Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-03-24
Enrollment: 45221
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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).

Eligibility 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

Primary outcomes:
measure: Prevalence of micro-organisms at an Egyptian Tertiary Care Hospital
timeFrame: one year
measure: generation of ICU specific antibiogram
timeFrame: one year
measure: the incidence of antibiotic susceptibility and resistance pattern of these micro-organisms
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Emergency, Surgical Intensive Care Units,medical, pulmonary, coronary, neonatal, and pediatric ICUs-Zagazig University Hospitals
state: Sharkia
Study officials:
affiliation: Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
name: Sherif M Mowafy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University
name: Essamedin M Negm, MD
role: STUDY_DIRECTOR
affiliation: Clinical Pathology Department, Faculty of Medicine, Zagazig University
name: Ahmad A Mohammed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chest Department, Faculty of Medicine, Zagazig University
name: Tarek H Hassan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Pathology Department, Faculty of Medicine, Zagazig University
name: Marwa G Amer, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical pharmacist, Zagazig University Hospitals
name: Ahmed E Tawfik, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: 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.
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.
citation: 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.
citation: 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.
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.
citation: Cheesbrough M. District laboratory practice in tropical countries part II. 2. NewYork: Cambridge University Press; 2006.
citation: 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.
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.