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CompletedNCT05002647Updated Dec 27, 2024

Relationship Between the Clinical Pharmacist & Antibiotic Use by Using the Electronic Program

An observational study in Clinical Pharmacists and Electronic Medical Record, sponsored by Alexandria University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Alexandria University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,601
Sex
All
01

Study 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.

Read the detailed 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.
02

Conditions studied

  • Clinical Pharmacists
  • Electronic Medical Record

Keywords

  • clinical pharmacist
  • antibiotic consumption
  • antibiotic use
  • cost-saving
03

In context

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients who administered antimicrobials

Inclusion criteria

  • All inpatient with infectious disease (disorders caused by organisms as (bacteria, viruses, fungi, or parasites).

Exclusion criteria

Exclusion Criteria:

  • Any other cause of hospital admission other than infectious disease.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,601 participants (actual)
Patient registry
No

Groups and cohorts

  • exposure group

    Data from electronic clinical pharmacist records of two infectious disease hospitals

    Other: NO intervention

  • Non-exposure group A

    Data from medical records of the hospital with no clinical pharmacy.

    Other: NO intervention

  • Non-exposure group B

    Data from a medical record of the hospital with clinical pharmacy, but the department did not cover by the clinical pharmacy

    Other: NO intervention

Interventions

  • OtherNO intervention

    There is no intervention

06

What researchers measure

Primary outcomes

  1. Antimicrobial consumption

    consumption of antimicrobials (defined daily doses / 100 patient-days)

    Time frame: 2 years

  2. Days of therapy (DOT)

    Number of days of each antimicrobial received for therapy

    Time frame: 2 years

  3. Length of therapy(LOT)

    The number of days a patient takes an antibacterial drug, regardless of the number of different medications

    Time frame: 2 years

Secondary outcomes

  1. cost savings

    (initial treatment cost × days before intervention) - (cost after intervention × days with this treatment),

    Time frame: 2 years

  2. Mortality rate

    in-hospital mortality rate (%)

    Time frame: 2 years

  3. 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.

    Time frame: 2 years

  4. The incidence of adverse reaction of antimicrobial

    An unexpected medical problem that happens during treatment with antimicrobial.

    Time frame: 2 years

07

Study locations

1 site
  • Ministers of health
    Alexandria, 22511, Egypt
08

References and documents

Publications

  • 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. PubMed 30981652 ↗
  • 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. PubMed 28882725 ↗
  • 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. PubMed 31323427 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05002647
Lead sponsor
Alexandria University
Collaborators
Ministry of Health and Population, Egypt
Responsible party
Sponsor
First posted
Aug 12, 2021
Start date
Sep 15, 2021
Primary completion
Jan 1, 2022
Completion
Mar 10, 2022
Last update
Dec 27, 2024

Study contacts

Amira zidane
principal investigator · Ministry of Health and Population, Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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