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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05002647
Other study ID # 14-2021/13
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 15, 2021
Est. completion date July 1, 2022

Study information

Verified date August 2021
Source Alexandria University
Contact Amira zidane
Phone 00201024585329
Email amira.zidan2yahoo@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective cohort study to explore the association between clinical pharmacists' interventions and antibiotic consumption through the use of the medical electronic reports and to identify mortality and cost savings in hospital infectious disease.


Description:

The role of clinical pharmacist includes : 1. a check of suitable selection and dosing of antimicrobials according to the diagnosis, type of infection, antimicrobial cultures as possible, comorbidities of patients (renal or hepatic function, etc), adverse effect, and drug interaction with other drugs. 2. Documentation of the clinical intervention, cost-saving, adverse effect,, antimicrobial culture and antimicrobial consumption on the electronic program (CPC "clinical patient care"). 3. The clinical pharmacist inspector reviews the data recorded on CPC.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3000
Est. completion date July 1, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All inpatient with infectious disease (disorders caused by organisms as (bacteria, viruses, fungi, or parasites). Exclusion Criteria: - Any other cause of hospital admission other than infectious disease.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
NO intervention
There is no intervention

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Alexandria University Ministry of Health and Population, Egypt

References & Publications (3)

Dyar OJ, Huttner B, Schouten J, Pulcini C; ESGAP (ESCMID Study Group for Antimicrobial stewardshiP). What is antimicrobial stewardship? Clin Microbiol Infect. 2017 Nov;23(11):793-798. doi: 10.1016/j.cmi.2017.08.026. Epub 2017 Sep 4. Review. — View Citation

Karakonstantis S, Kalemaki D. Antimicrobial overuse and misuse in the community in Greece and link to antimicrobial resistance using methicillin-resistant S. aureus as an example. J Infect Public Health. 2019 Jul - Aug;12(4):460-464. doi: 10.1016/j.jiph.2019.03.017. Epub 2019 Apr 10. Review. — View Citation

Ourghanlian C, Lapidus N, Antignac M, Fernandez C, Dumartin C, Hindlet P. Pharmacists' role in antimicrobial stewardship and relationship with antibiotic consumption in hospitals: An observational multicentre study. J Glob Antimicrob Resist. 2020 Mar;20:131-134. doi: 10.1016/j.jgar.2019.07.009. Epub 2019 Jul 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Antimicrobial consumption consumption of antimicrobials (defined daily doses / 100 patient-days) 2 years
Primary Days of therapy (DOT) Number of days of each antimicrobial received for therapy 2 years
Primary Length of therapy(LOT) The number of days a patient takes an antibacterial drug, regardless of the number of different medications 2 years
Secondary cost savings (initial treatment cost × days before intervention) - (cost after intervention × days with this treatment), 2 years
Secondary Mortality rate in-hospital mortality rate (%) 2 years
Secondary Antimicrobial resistance resistance defined as resistance to at least one antimicrobial from the panel for all organisms, and for a subset of organisms belonging to the ESKAPE group (Enterococcus faecium, S. aureus, Klebsiella pneumonia, Acinetobacter baumannii, Pseudomonas aeruginosa , and Enterobacter spp. 2 years
Secondary The incidence of adverse reaction of antimicrobial An unexpected medical problem that happens during treatment with antimicrobial. 2 years
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